CIRM’s Thomas Blogs on Geron and the Stem Cell Business

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The chairman of the $3 billion California stem cell agency has made his second entry into the blogosphere, this time adding a bit more on Geron's abandonment of what would have been its historic hESC clinical trial.

Jonathan Thomas, a Los Angeles bond financier, wrote yesterday on the CIRM research blog, which has recently been the site of more spritely and relevant items.

Geron's action has particular relevance for CIRM, which awarded the company a $25 million loan last May to help with the clinical trial.

Thomas said CIRM's "immediate concern" when officials heard the surprise news was for the patients and the families involved in the trials. Thomas continued,

"However, Geron is a business. The company decided that their cancer therapies were farther along than the stem cell trial and when they held the stem cell program against the prism of economic reality they made a business decision to end the trial."

Thomas also minimized the importance of Geron to CIRM. He said,

"CIRM’s award to Geron was just one of the 44 projects in 26 disease areas that are in various stages of working toward clinical trials."

It was a somewhat different story last May when former stem cell agency chairman Robert Klein said in a widely distributed CIRM news release,

"Supporting the Geron trial is a landmark step for CIRM."

Regardless of the spin on Geron from either CIRM or others who are more skeptical, Thomas' entry into the world of electronic media is to be applauded as is what appears to be a new direction in the research blog.

The CIRM blog is now newsier, more lively with more variety and more voices. All of which should redound, albeit modestly, to CIRM efforts to improve its communications with the public and opinion makers. The difficult thing about blogs, however, is the time and effort required to sustain them, and the task could be something of a communications test for CIRM. Blogs constantly need to be fed. Indeed, blogs are voracious, sort of like the carnivorous plant called Seymour in "The Little Shop of Horrors." As many of you may recall, Seymour had a simple but insistent refrain, "Feed me, feed me, feed me."

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Stem Cell Awards of the Year: From Geron to iPS ‘Warts’

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The end of the year is a traditional time for the media to come up with lists of both the dubious and meritorious events and personages of the year. This year's nominations from a California stem cell researcher include Geron, Roman Reed and the new chairman of the California stem cell agency.

Paul Knoepfler, a stem cell scientist at UC Davis and one of the few stem cell scientists who blogs regularly, today revealed his awards for 2011. They ranged from the political cartoon of the year to the stem cell scientific issue of the year.

Geron was named in the "misstep of the year." Knoepfler wrote,

"You guys really screwed up by dropping your stem cell program in this manner. I believe this bordered on the unethical. I commend the actual stem cell scientists at Geron, but the person(s) who as leaders pulled the trigger on killing the stem cell program did wrong."

Roman Reed was named "stem cell activist of the year." Reed is the man who came up with the CIRM motto several years ago, "Turning stem cells into cures." He has long been active on stem cell issues, along with his equally hard-working father, Don Reed.

Jonathan Thomas, the relatively new chairman of the stem cell agency, was named "stem cell leader of the year." Thomas was elected chairman of the agency in June, replacing Bob Klein, who stepped down. Knoepfler wrote that Thomas "has impressed the stem cell community and made some very positive changes at CIRM to make an awesome organization even better."

Knoepfler has much more,  including the stem cell biotech of the year –
Advanced Cell Technology of Santa Monica, Ca. – which Knoepfler said has two hESC trials on track and an "impressive scientific leadership." Not to be overlooked is the stem cell scientific issue of the year – "warts" or genetic changes -- at least possible ones involving iPS cells. Knoepfler points out that the subject has drawn a vast number of citations in journal articles.

We should not forget the stem cell blog of the year, which came in as a tie between Stem Cell Network of Canada and Stem Cell Assays by William Gunn of San Diego and Alexey Berseney of Philadelphia. Knoepfler also mentioned the CIRM Research Blog, overseen by Amy Adams, and the California Stem Cell Report. Knoepfler said the California Stem Cell Report "is read by a who’s who of the stem cell world, and is a source of important information about CIRM," although Knoepfler said he wished the blog was more balanced "in terms of positive and critical stories." However, Knoepfler did note that several more positive items have appeared recently, but this analyst warns of the perils of excessive exuberance.

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The CIRM ‘Debt’ to George Bush and Disgraced Korean Researcher

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It was brief but pointed comment on the differences in the stem cell world of 2004 compared to the stem cell world of 2011.

Larry Ebert, a patent attorney, made the remark on his blog, IPBiz. He was writing about an observation on this website that without George Bush and his restrictions on federal hESC research, there would have been no California stem cell agency.

Ebert said,

"IPBiz notes that when the California voters voted Prop. 71 in, scientists thought Huang Woo Suk's work on hESC was real. In 2011, the current state of the art is still not up to what Huang Woo Suk falsely reported in the journal Science. Californiastemcellreport should give Huang Woo Suk some credit for the passage of Prop. 71."

Consider Woo Suk duly credited.

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Los Angeles Times: ‘Geron Fiasco’ Poses Questions About California Stem Cell Agency

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The Los Angeles Times, California's largest circulation newspaper with more than 900,000 subscribers, today said the "Geron fiasco" raises questions about the conduct of business at the California stem cell agency and whether it "does a disservice to patients and taxpayers."

The comments came in a column by Pulitzer Prize-winning journalist and author Michael Hiltzik, who wrote about Geron's abandonment of its hESC trial only five months after the firm was awarded a $25 million loan by the stem cell agency. Hiltzik said,

"So we're talking at least about months of wasted effort by CIRM and Geron's researchers, crushing disappointment for those patients and conceivably a major setback for stem cell science generally. (CIRM Chairman Jonathan) Thomas observes that Geron said it made its decision strictly on financial grounds, not because of scientific reversals. But for an R&D company financial considerations always encompass scientific judgments, and Geron plainly concluded that the prospect for profits from stem cell therapies was receding.

"The Geron fiasco underscores the old questions, and raises new ones, about what CIRM is supposed to accomplish, how it does business and whether its addiction to hype does a disservice to patients and taxpayers."

Hiltzik's column contained brief remarks from Thomas. The columnist wrote,

"'There are going to be fits and starts,' its chairman, Jonathan Thomas, told me last week. Even so, he maintained, 'we remain unwavering in our commitment to pursuing the science.'"

Hiltzik has followed CIRM since the 2004 ballot initiative campaign that created the $3 billion enterprise. The effort was headed by real estate investment banker Robert Klein, who later served as CIRM's chairman for seven years. Hiltzik wrote,

"CIRM loves to compare itself to the federal government's biomedical research agency, the National Institutes of Health, but the two bodies are very different. The responsibilities of NIH are broad enough for it to make disinterested judgments about programs and scientific approaches. CIRM, however, was designed from the start (by Klein, who oversaw the drafting of Proposition 71) to focus on a very narrow field of biomedical science — embryonic stem cell research — and to promote that research in California as a sort of economic development tool.

"These two goals have always been ethically and scientifically incompatible, and the Geron case points to why."

Hiltzik said evidence exists to show that CIRM "downplayed legitimate questions about the state of Geron's science and the design of the clinical trial" in its efforts to fulfill the excessive promises of the electoral campaign. The issues, he said, included over-promising results, questions by other researchers about the trial and whether a spinal cord injury was the best subject for the first tests of stem cell therapies on humans.

Hiltzik continued,

"None of these issues were aired publicly in the run-up to the vote, because CIRM didn't disclose in advance that Geron was the loan applicant. Nor did it disclose that its own scientific review panel had awarded the Geron trial a scientific score of only 66 out of 100; that fact, along with other details of the board's consideration of the Geron loan, was pried out of CIRM later by David Jensen, the tireless proprietor of the indispensable California Stem Cell Report.

"CIRM told Jensen that although it customarily discloses its reviewers' scientific scoring of funding proposals, it didn't in this case because it was using 'new criteria' and thus the public might not find the result 'meaningful.' Call me a cynic, but I'd bet that if the score were, say, 90 out of 100, CIRM would have shouted it from the rooftops, rather than pleading that Californians were too dumb to understand what the number meant."

Hiltzik concluded,

"Another problem illuminated by the Geron case is that CIRM remains infected by the hype virus. Only a week after Geron parachuted out of the stem cell business, Thomas issued a statement bemoaning the public impression that CIRM isn't making any progress toward therapies. He declared: 'CIRM is turning stem cells into cures.'

"Well, no it isn't, not yet. Geron's now-halted project was the most advanced human clinical trial in CIRM's portfolio; yet it was at an extremely early stage, involved all of five human subjects and might still have been years away from showing that a cure was even possible. CIRM needs to take a good look at whether it pushed too hard for the Geron loan and overplayed the significance of the trial; otherwise its path toward building credibility with the public will only get longer."

The California Stem Cell Report has asked CIRM Chairman Thomas if he would like to respond in more detail to the Los Angeles Times column, with a commitment to carry his remarks verbatim.

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$30 Million ‘Disease-in-Dish” Plan Wins Go-ahead from California Stem Cell Agency

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Directors of the California stem cell agency today approved a $30 million program that could generate "disease-in-a-dish models" that "have the potential to make drug discovery faster, more efficient and more personalized to individual patients."

The "human pluripotent stem cell (hPSC) initiative" is aimed at generating high quality stem cell-based tools for use by the researchers and drug developers.

The proposal includes four elements, one of which is a $300,000 collaboration with the NIH to develop cell lines from patients with Huntington’s Disease, Parkinson’s Disease, and Amyotrophic Lateral Sclerosis. The plan includes a $4 million disease line award round, a $16 million core hiPSC derivation round and a $10 million stem cell bank round. The RFAs would go out in May of next year with funding expected early in 2013.

The initial staff memo on the initiative did not mention human embryonic stem cells, but a spokeswoman for the agency said they were not excluded from the effort.

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The Ins and Outs of CIRM’s Push to Keep the Geron hESC Effort Alive

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The $3 billion California stem cell agency has confirmed that it is looking for companies to take over Geron's hESC business, but remained vague on the details of just what it is proposing as well as any financial incentives.

A certain ambiguity may appropriate because Prop. 71, the ballot initiative that created CIRM seven years ago, constrains the state research effort, which is engaged in an aggressive push to bring stem cell therapies into the marketplace.

After last week's New Scientist article in which CIRM President Alan Trounson said he was talking to at least three companies, the California Stem Cell Report emailed this inquiry to the agency:

"Re Trounson's comments about CIRM trying to find an enterprise to pick up the Geron hESC business, what form is that taking? Are CIRM officials contacting companies, asking them to consider the Geron business? Are promises being made that Geron's loan would be passed along to a new company? Are CIRM officials giving any sort of assurance that the new enterprise would be looked on favorably in terms of possible CIRM financing help, even a wink or some such thing?"

In response, Maria Bonneville, executive director to the CIRM board, said yesterday,

"Dr. Trounson is encouraging companies to take a hard look at the potential of this project. If any companies express a solid desire to continue the project, they would be thoroughly vetted through CIRM's existing procedures."

The stem cell agency is limited by law in what it can do encourage a deal for Geron's orphan business. Nonetheless it will have to move quickly if it wants to keep Geron's hESC team intact. Otherwise, those folks will be heading for more secure employment.

With some crafty lawyering, however, CIRM might be able to move its $25 million Geron loan over to a some sort of new entity if the clinical trial remains virtually identical.

The agency might also find a way to use a newly created $30 million "strategic partnership" program to support a deal involving Geron's stem cell program. CIRM's new program is industry friendly and aimed at early stages of clinical development.

However, by law, only a public vote of the 29-member board of directors can approve a loan or grant. That vote is taken in what is supposed to be a blind process in which the names of the applicants are not known. However, it is clear from last May's approval of the Geron loan that the directors knew the identity of the applicant although it was not announced publicly until after the formal 16-1 vote. The agency's procedures also call for action prior to the board vote by its grant review group, which makes the de facto decisions on grants.

The timeline on normal award rounds is lengthy – more than a year from concept to finish – and may not be appropriate in this case. Plus the rounds are open to more than one applicant.

CIRM's current award rounds for business involve loans not grants. The loan policy was developed, in part, because businesses objected to the financial hooks in grants. Originally, the loan program was created to fund business projects that otherwise could not find funding. The program was originally slated to run as high as $500 million. The interest was expected to finance additional research.

The agency also has geographic constraints. It cannot pay for work outside of California. So that would mean that a potential buyer probably would need a substantial presence in California unless the agency could put together a deal in which Geron is still in the game and doing some of the work.

The agency can receive warrants in loan deals but does not make stock investments. It probably cannot legally directly buy a stake in a company and thus provide a cash infusion.

A new arrangement for Geron's hESC business would need some likelihood of a substantial stream of cash over the next several years, based on what Geron said last week. But the current environment for early stage biotech investment is quite difficult. And then there is the FDA, which authorized the clinical trial and is likely to have something to say about who operates it.

Whether CIRM can overcome all these obstacles would seem to be problematic. But, of course, Geron is also shopping its business around. And some buyers might be attracted by a bargain basement price enhanced by the expectation of continued cash from the California stem cell agency.

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California Stem Cell Agency Takes Initiative in PR ‘War’

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Jonathan Thomas, chairman of the $3 billion California stem cell agency, took to the blogosphere today with an item promoting CIRM's progress, declaring that it is a record of which Californians can be proud.

In his debut performance as a blogger, Thomas declared that the agency has 43 research projects that are in various stages of moving towards clinical trials. He wrote on CIRM's research blog,

"Given that it normally takes a decade or longer for a basic science discovery to reach clinical trials, 43 projects seemed to me like quite an achievement – an achievement that the people of California should take pride in supporting. Not only is CIRM driving stem cell science in our state, but through our national and international collaborations California has become a stem cell hub that accelerates stem cell progress worldwide."

Thomas, a Los Angeles bond financier, pointed to a new document from CIRM, titled "Funding therapies: Fueling Hope." It summarizes some of the agency's work and touts the "incredible potential" of stem cells.

The document also explains the laborious process for creating a therapy before it can be brought to market and actually used to treat patients. The document said,

"Altogether, carrying out the basic research, translational work and preclinical data leading up to a clinical trial can take a decade or longer, and that's just to start the clinical trial. CIRM’s funding approach speeds that timeline by providing stable funding that eliminates pauses in the research to raise new funds, by strategically funding areas thought to be barriers to the clinic and by forming teams of researchers who work in parallel rather than sequentially to reach clinical trials faster."

When Thomas was elected chairman of the agency last June, he told directors that the agency was in a "communications war" in which its record was not fully appreciated by the public. He made telling the CIRM story one of his top priorities.

Today's blog posting by Thomas and, more particularly the "Fueling Hope" document, will be useful to CIRM in dealing with the overblown expectations of rapid cures that were generated by the hype of the 2004 ballot initiative campaign that created the stem cell research program.

The campaign generated impressions among voters that cures – specifically human embryonic stem cell cures – were just around the corner and that the Bush Administration, with its restrictions on hESC research, was the only thing standing in the way. Indeed, without George Bush, there would be no state stem cell agency  since his stand against hESC created an apparent need for alternative funding. For voters who expected instant cures, however, CIRM must be a sad disappointment since it has developed no therapy that is being used to treat people.

Managing expectations is a critical task for CIRM, which will run out of funds in 2017 and which is expected to be asking voters for another multibillion dollar bond measure sometime in the next few years.

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Possible Buyers for Geron’s Stem Cell Business: BioTime, Pfizer, Celgene

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The mainstream media is climbing all over the Geron story today with more analysis and a  discussion of firms that might snag the San Francisco area firm's orphan stem cell business.

Reporter Peter Loftus of the Wall Street Journal mentioned Pfizer, which is involved an hESC project with researcher Peter Coffey, who was lured from the UK this fall to UC Santa Barbara. Among the incentives was a $4.9 million grant from the California stem cell agency, which also financed Geron to the tune of $25 million.

Matthew Perrone of The Associated Press had this to say about buyers:

"Analysts say Geron's stem cell business could be acquired by Alameda, Calif.-based BioTime, a company founded by former Geron scientists. Other potential acquirers could include larger pharmaceutical companies like Celgene Corp., Pfizer Inc. and Teva Pharmaceuticals, which have dabbled in stem cells without making major investments."

BioTime's shares were up 7 percent today, closing at $4.52. Geron's shares were down as much as 28 percent and hit a five-year low. It closed at $1.71, down 22 percent.

The AP also wrote,

"Joseph Pantginis, an analyst with Roth Capital Partners, said it would have taken five to ten years before Geron's lead stem cell product reached the market.

"'This is still very much a fledgling space and some people would even consider stem cells to be a science experiment, so there's still a long way to go,' said Pantginis.

"University of Wisconsin professor Alta Charo said Geron's move 'may suggest that a different business model is needed, one with a longer timeline for return on investment.'"

Charo had close ties early on with the $3 billion California stem cell agency, which loaned $25 million to Geron just six months ago. The loan was part of an aggressive effort to produce clinical results that will help extend the agency's life beyond 2017, when funds are expected to run out. Currently CIRM is financed through California state bonds, which will need to be approved by voters again if CIRM is to continue.

Here are more excerpts from today's coverage.

Gretchen Vogel of Science magazine wrote,

"Some observers had reservations about the trial from the start, worrying that the animal results were not strong enough to justify a human trial. But many had been pulling for the company nonetheless. 'It's with a sense of loss that I see this news,' says Roger Pedersen of the University of Cambridge in the United Kingdom, who was one of the researchers to receive funding from Geron in the mid-1990s to attempt to derive hES cells. He says the company may be reacting not only to the long timeline to bring cell therapies to the clinic, but also to a possible weakening of its intellectual property portfolio. The development of induced pluripotent stem (iPS) cells, which are adult cells genetically reprogrammed to resemble embryonic ones, means that Geron's exclusive licenses may be worth less. 'Advances in the stem cell field are disruptive innovations that have the potential to supercede earlier innovations, hES cells being one of those. I don't know if Geron looks at it that way, but I do,' Pedersen says."

Ben Hirschler and Kate Kelland of Reuters reported:

"A decision by one of the biggest names in stem cell research to throw in the towel will not stop other pioneering work that could yet produce cures for blindness and help mend broken hearts.

Scientists were shocked by U.S. biotech company Geron Corp's decision on Monday to quit embryonic stem cell research -- a move it blamed on a lack of money and the complexities of getting regulatory approval....

"Robert Lanza, chief scientific officer of ACT, is not giving up hope on the embryonic front but said Geron's exit put more pressure on his firm to succeed.

"'Of course, it's the second mouse that often gets the cheese,' he said."

Sarah Boseley of The Guardian in the UK wrote:

"The dream of Superman actor Christopher Reeve and others of paralysed people being able to walk again after injections of stem cells has receded, following the announcement by biotech company Geron in the US that it is to abandon the first-ever human trial of its kind."

Jef Akst of The Scientist magazine wrote:

"'It’s certainly going to have a very chilling effect,' said Robert Lanza, chief scientific officer at Advanced Cell Technology, the only other company currently engaged in clinical trials involving hESCs. 'There’s a lot of exciting potential here in this field, and it would just be a real shame for this not to move ahead full steam.'...

"One thing working in the field’s favor is the fact that Geron helped pave the regulatory way for other stem cell therapies, said Sheng Ding, a stem cell biologist at the Gladstone Institutes and the University of California, San Francisco. 'Geron’s past efforts had cleared out a FDA path for pluripotent stem cells,” he wrote in an email to The Scientist."

The Financial Times of London altered its original story by Andrew Jack without notifying its readers that the story was changed or why. The old version began.

"Geron, the pioneering stem cell therapy company, has dealt a powerful blow to one of the most hyped areas of medicinal research by withdrawing entirely from the field."

The new version, posted at least 12 hours later, begins:

"Geron, the Californian biotech company, is abandoning its pioneering embryonic stem cell work, after concluding that the costs and length of further development were too great."

Matthew Herper of Forbes published a comment from Jamie Thomson of the University of Wisconsin, whose hESC discoveries were financed in part by Geron. Thomson wrote,

"Geron’s decision to discontinue their stem cell work reflects how genuinely difficult it is to build a business around embryonic stem cell-based transplantation therapies. They also chose a particularly challenging target for the first therapeutic application. They are to be commended, however, for blazing a trail that others can follow in getting the first clinical trial approved by the FDA, as such approvals should be easier in the future."

Herper continued,

"Thomson initially shied away from the idea of building businesses around embryonic stem cells or their successors, induced pluripotent stem cells, which don’t involve destroying embryos. (He told me three years ago, 'I really believe personally that the value of these cells is not in transplantation,' and that '90% of the value of these cells will be in things that don’t make the front pages.') When Thomson did decide to become an entrepreneur, it was through a Madison, Wisconsin-based startup called Cellular Dynamics International, which uses the cells to create better ways of testing the safety and effectiveness of experimental drugs. Drug giants including Roche, Pfizer, and AstraZeneca have taken their own steps toward embracing stem-cell-based research. This field is slowly gaining steam just as the one Geron is abandoning its own attempts to heal the lame."

Brian Orelli on the MotleyFool investment web site wrote,

"Geron is giving up on stem cells. That's like Krispy Kreme Doughnuts without glazed treats, or Apple without Macintosh."

Adam Feuerstein on thestreet.com wrote:

"Geron's  decision to shut down its embryonic stem cell research programs is a blow to the controversial research field and a painful reminder that only dreamers and fools invest in embryonic stem cell stocks....But does anyone believe that Geron would jettison stem-cell research if the ongoing clinical trial in spinal cord injury were helping patient recover neurological or motor function?"

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Geron hESC Withdrawal ‘Real Blow’ to California Stem Cell Agency, Says CGS

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In a sharp-edged analysis of Geron's abandonment of stem cell research, the Center for Genetics and Society yesterday described the action as a "real blow" to the California stem cell agency.

Written by Pete Shanks, a regular contributor to the Berkeley center's Biopolitical Times, the piece chronicled some of the history and hype involving Geron and hESC research. The center has long taken a skeptical view of the California stem cell agency and Geron. Shanks wrote,

"Geron has been in trouble for a while. Former CEO Thomas Okarma, who left abruptly in February, was the subject of ridicule for his repeated announcements that ESC-based clinical trials would begin "next year" — that is, 2005, 2006, 2007, 2008 — and the trial they eventually came up with was so dubious that Arthur Caplan called it "nuts and hugely risky." Even experts in the field thought that targeting spinal cord injury in the first ESC trial was dubious, though some seem to be more willing to be critical now it has ended.

"And that was on the scientific and perhaps commercial merits. The ethical problems were much worse, since the trial was intended for people who had recently suffered damage to their spinal cords. Bioethicist Laurie Zoloth (who was once on Geron's ethics advisory board, and basically approved of the study), noted at the time of its announcement that:

"'True informed consent in this very vulnerable population, people who have suffered a devastating and life-changing injury a week prior to being asked to enter the first clinical trial for such long-awaited, highly publicized and desperately needed treatment, is hard to obtain and will need to be carefully thought through.'"

Shanks also wrote,

"What of CIRM's role? After Geron's announcement, they issued a remarkably bland press statement, followed by an internal memo that expressed deep disappointment (the California Stem Cell Report has the text). It's a real blow to them: Geron was the first private company to receive funds from CIRM to run a clinical trial using ESCs.

"This was a loan, not a grant, and was only made, as the indefatigable David Jensen (publisher of the California Stem Cell Report) discovered, after a 'major departure from longstanding procedures.' The proposal received a low score (66/100) that was not publicly revealed until Jensen specifically asked for it. And the other applicants who might have competed for those funds rather surprisingly all withdrew.

"The suspicion arises that CIRM, or some people within it, badly wanted the trial to proceed in the hope that it would give them a therapeutic success to boast about. If so, the decision just backfired."

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International Stem Cell Corporation Comments on WSJ Article “Hope for Stem-Cell Treatment of Parkinson’s”

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“Researchers have used stem cells obtained from human embryos to successfully treat Parkinson's disease in mice and rats, a key step in the quest to develop a similar approach for people.
In a study published Sunday in the journal Nature, scientists described how they converted human embryonic stem cells into nerve cells that produced the brain chemical dopamine. When these nerve cells were transplanted into the brains of mice and rats, they released dopamine and got rid of the animals' Parkinson's symptoms. The cells were also successfully transplanted into rhesus monkeys, whose biology is closer to that of humans.”
SOURCE - To read the complete article on The Wall Street Journal HEALTH site, please click HERE
Comments from International Stem Cell Corporation:

International Stem Cell Corporation (ISCO) announced in July 2011 the initiation of a series of preclinical animal studies of neuronal cells derived from ISCO’s proprietary pluripotent stem cells. The studies will evaluate the in vivo safety and tumorigenicity of neuronal cells derived from ISCO's proprietary human parthenogenetic stem cells (hpSCs), as well as their ability to develop into functioning dopaminergic neuron–like cells, a key milestone towards creating a cell-based therapy for Parkinson's Disease (PD).

Dr. Andrey Semechkin, Co-Chairman and CEO of ISCO, comments: “The ability of neuronal cells to become a specific type of neuron is one of the most important properties that these cells must have to be used in cell-based therapy of neurological disorders. These studies will bring us one step closer to our goal of being able to treat PD.”


Forward-looking Statements
Statements pertaining to anticipated developments, research and development goals and related potential therapeutic treatments, the potential benefits of products, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward- looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates,") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products and the management of collaborations, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.

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$127 Million in ‘Good News’ for San Diego Stem Cell Researchers

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Earlier today, an anonymous reader posted a comment on the California Stem Cell Report wondering where the "good news" was about the stem cell agency. We are not sure whether the reader was wondering about the content of this site or the mainstream media or both.

Sanford Consortium lab from live Webcam shot this weekend
on the Sanford web site. 

But the comment came less than 24 hours after a San Diego area newspaper published a glowing piece about the opening of a new stem cell research building under the auspices of five powerful research organizations – Salk, Scripps, Sanford Burnham, UC San Diego and the La Jolla Institute for Allergy and Immunology, a recent addition to the consortium.

Bradley Fikes of the North County Times wrote the story. He may be the last reporter in California to regularly, albeit infrequently, cover California stem cell issues for a mainstream newspaper.

Fikes' story heralded the $127 million structure. (The cost includes equipment.) He wrote,

"San Diego County's bid for supremacy in the fast-growing field of stem cell research will gain an iconic new image Nov. 29, when a gleaming headquarters for some of San Diego County's top stem cell researchers officially opens.

"The 132,000 square-foot building off in La Jolla will become the headquarters of the Sanford Consortium for Regenerative Medicine...."

The consortium was formed in the wake of voter approval of Prop. 71, which created California's $3 billion stem cell program and provided hundreds of millions of dollars for new labs. Edward Holmes, formerly vice chancellor at UC San Diego, is president and CEO of the consortium. Holmes is also chairman of the National Medical Research Council in Singapore. (For Holmes perspective on the consortium, see this 2010 interview.)

The building was financed with $43 million from the California stem cell agency, $65 million in bonds guaranteed by the University of California and $19 million from T. Denny Sanford, a South Dakota billionaire banker.

After CIRM approved funding for the building in May 2008, the consortium struggled with finding cash beyond what CIRM provided. The roadblocks delayed work on the facility, which was supposed to be completed by May 2010 at a cost of $155 million, according to the stem cell agency.

Like the other new labs assisted by $271 million in stem cell agency construction funds, the San Diego building is touted as conducive to bringing scientists together. Indeed, it has been dubbed a "collaboratory."

Fikes wrote,

"Even the staircases have been designed in keeping with the goal of making as much space as possible serve collaboration. The Sanford Consortium's staircases are wide, open and airy. They connect multiple 'laboratory neighborhoods' on different levels, so that scientists from different labs and floors will inevitably pass each other on their way to work."

Fikes said that at each level the staircases include areas with tables and chairs for quick chats. He quoted Louis Coffman, chief operating officer of the consortium, as saying,

"It's a lively interlude between floors. It creates an interesting space. More than that, it connects the physical locations of two different floors. So whereas people on different floors, who would otherwise be as disconnected as they would be in different buildings, hopefully they're going to make connections."

Source:
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Geron Flight from hESC Research is ‘Powerful Blow’

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The news about Geron's abrupt departure from hESC research is rippling around the world this morning, casting a pall over the entire field.

The Financial Times of London, in a story by Andrew Jack, said,

"Geron, the pioneering stem cell therapy company, has dealt a powerful blow to one of the most hyped areas of medicinal research by withdrawing entirely from the field."

Ron Leuty at the San Francisco Business Times said in an analysis,

"Just why would I want to invest in a space where one of the most promising companies just called it quits."

In a Washington Post article by Rob Stein, a patient advocate expressed bitterness.

"'I’m disgusted. It makes me sick,' said Daniel Heumann, who is on the board of the Christopher and Dana Reeve Foundation. 'To get people’s hopes up and then do this for financial reasons is despicable. They’re treating us like lab rats.'"

Geron, based in the San Francisco peninsula city of Menlo Park, cited financial problems when it announced yesterday that it was giving up on its stem cell efforts in favor of its cancer drug program. Geron is laying off 38 percent of its staff and says it will try to find a buyer for the stem cell program. Geron also settled its accounts with the California stem cell agency, which loaned it $25 million last May amidst considerable publicity.

The stem cell agency and other advocates expressed optimism about the long term potential of the field and noted the difficulties of bringing any therapy to production. Geron produced 21,000 pages of material over a years-long period to get FDA permission to begin only the first step in the long clinical trial process.

But the dominant tone of the news stories was negative. Heidi Ledford of Nature said Geron is "walking out on the field." Steve Johnson of the San Jose Mercury News said the decision casts "a cloud over the commercial viability of stem cell treatments."

Here are other excerpts:

San Francisco Business Times:

"What does this mean for companies that the California Institute for Regenerative Medicine, the state’s stem cell research funding agency, is pushing toward clinical trials? Will they only get so far before they, too, exit the business?" 

Fergus Walsh, medical correspondent for the BBC(see here), wrote:

"The decision does seem to be extraordinary given the huge investment of time and resources. When I visited Geron nearly three years ago, the then chief executive claimed the technology had an incredible future. 

"John Martin, professor of cardiovascular medicine at University College London said: 'The Geron trial had no real chance of success because of the design and the disease targeted. It was an intrinsically flawed study. And for that reasons we should not be describing this as a set back. 

"The first trials of stem cell that will give an answer are our own in the heart. The heart is an organ that can give quantitative data of quality.'"

Ryan Flinn of Business Week wrote,

"Geron fell 16 percent to $1.86 in extended trading. The shares have declined 58 percent this year.  

Robert Lanza, chief scientific officer of Advanced Cell Technology Inc.(of Santa Monica, Ca.), the second company to win permission from the U.S. Food and Drug Administration to test human embryonic stem cells in people, said the news wasn’t surprising, given the small patient population affected with spinal cord injuries. 

"'It was a very difficult choice to go in and treat spinal cord injury,' Lanza said in an interview. 'There was considerable concern in the scientific community that that might not have been the ideal first indication."

As first reported by the California Stem Cell Report, Geron's loan application was scored as a 66 on a scale 100 last May by scientific reviewers for the California stem cell agency. The score was not disclosed publicly at the time CIRM directors approved the award as has been the practice for all the other 400-plus awards that the agency has granted. The Geron approval process departed radically from the agency's regular procedures.

The news coverage in California of the Geron decision was marked by the absence of a story in the Los Angeles Times, the state's largest circulation newspaper. The San Francisco Chronicle carried only a brief story buried on page 6 of its business section. The California stem cell agency is based in San Francisco and the Bay Area contains one of the larger and more important biotech business and academic research communities in the world.

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Patrick Cox’s Breakthrough Technology Alert: International Stem Cell Corp. Progressing Despite Incompetent MSM

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October 11, 2011
International Stem Cell Corp. Progressing Despite Incompetent MSM
Dear Breakthrough Technology Alert Reader,
"American journalism (like the journalism of any other country) is predominantly paltry and worthless. Its pretensions are enormous, but its achievements are insignificant."
Last week, an article by Rob Stein appeared in The Washington Post titled "Scientists Report Possibly Crucial Advance in Human Embryonic Stem Cell Research." Stein, whose credentials include science editor positions at NPR and The Washington Post, describes the use of cloning techniques to turn oocytes, immature eggs, into embryonic cells. The first one-sentence paragraph is as follows:
"Scientists reported Wednesday that for the first time, they had used cloning techniques to generate embryonic stem cells containing the genes of specific patients."
Frankly, I don't know what that sentence means. Somatic cloning of stem cells has been going on for years at places such as the Harvard Stem Cell Institute and the University of California San Francisco. It's not a particularly difficult thing to transfer adult DNA into an embryonic stem cell. Maybe the researchers said that it was the first time that "they" had used cloning techniques to make ESCs and the writer misinterpreted their statements. I have no idea.
Moreover, that sentence includes the word "patients." There were no patients involved in the study. It was a laboratory demonstration of a cloning technique in which DNA from mature cells is transferred into immature eggs, oocytes. Then, the oocytes transformed into stem cells with the implanted genes. The interesting thing about the procedure, which you can access here, is that the DNA from a normal cell, from two parents, was added to a cell with only a mother's genes.
This resulted in a cell with the DNA of three people -- a triploid cell. While fascinating, it also raises all kinds of scientific and safety issues. We have no idea what triploid cells would actually do if they were implanted in a patient. With extra haploid matching points, they might even be immunocompatible with no one.
I do, however, have a great script idea if somebody with money would like to hear the pitch. I'm thinking Species meets Mommie Dearest. Regardless, the possibility that triploid cells will be therapeutically useful in the foreseeable future is very low.
This brings me to the real flaw in the story. Read the second sentence/paragraph:
"The step marks a possibly pivotal advance toward the long-sought goal of creating stem cells that could be used to treat many major diseases, because they would not be rejected by patients' immune systems."
Balderdash. There are at least two solutions already available for dealing with immune rejection -- induced pluripotent stem cells (iPSCs) and human parthenogenic stem cells (hpSCs).
The iPS cell technology uses an individual's own cells to create cells that are functionally equivalent to embryonic stem cells. These would be compatible with the donor. The other solution is the human parthenogenic stem cells developed by International Stem Cell Corp. (OTCBB:ISCO). These, scientists believe, will solve the immune rejection problem on a mass-market basis.
ISCO long ago demonstrated that they have made the "pivotal advance" using oocytes, to which the Post article refers. ISCO scientists discovered and patented the techniques that successfully create human parthenogenic stem cells (hpSCs), which can be programmed to become any other cell type. With ISCO's cell banks, which will match the various HLA profiles of the human species, the immune rejection problem will be solved for the vast majority of the human race.
You will recall from my recent issue about ISCO that the company has already begun collecting oocytes to create these parthenogenic cells lines. It does so with complete approval of regulatory and ethical agencies.
As you know, it took ISCO many years and millions of dollars to accomplish their technological breakthrough. Interestingly, it had previously been done, apparently in an accidental and nonreproducible manner. Stem cell scientist Woo Suk Hwang of Seoul University announced in 2004 that he had produced a stem cell line derived from an embryonic human clone. Later, it was discovered that Hwang did not have a cloned stem cell line. He had a parthenogenic stem cell line.
Though Hwang was disgraced, the irony is that cloned stem cell lines are far easier to produce than hpSC lines. I don't understand all the details about what he did, wrong or right. The irony is this, however: If he had presented his stem cells as hpSCs, he might have been acclaimed a scientific hero, instead of the super-villain he is considered today.
The Washington Post article goes on to cite the usual stem cell controversies. Those opposed to ESC research have voiced opposition to the triploid stem cell technology when asked. They believe the triploid cells are embryonic stem cells. Since they are, in a sense, fertilized, that may be true. It's not at all clear, though, that they could develop into an embryo. I doubt it.
Also, the fact that some fertility therapy patients were paid well for oocytes unneeded in the fertilization process has caused serious concern among feminist commentators. They are seriously concerned. Seriously.
The big point, however, is that this article badly misrepresents the state of the science. ISCO scientists have long had the ability to create pluripotent stem cells using oocytes. More to the point, cells made using their process have none of the ethical issues of these triploid cells. They are not fertilized and cannot become embryos. They require no genetic manipulation. No foreign DNA is inserted into them. The company does not pay for oocytes and has followed every ethical guideline acquiring them.
The Wall Street Journal apparently picked up on the "breakthrough" story and helped spread the disinformation, as did other news outlets and bloggers. I'm not, per se, a journalist, but if I were writing for a nationally read publication that purports to present science accurately, I would have started by checking around to see if there were other perspectives on stem cells from parthenogenic oocytes.
In fact, I did a simple Google search using key words "parthenogenic" (or "parthenogenetic"), "stem" and "cell." The first page yielded this link to ISCO's description of their human technology.
Then, looking around the site, we find a list of respected scientific partners who are assisting in further research on ISCO's hpSCs, as well as some of their research areas.
They include:
Novocell Inc., San Diego, Calif., endocrine pancreas cells.
University of California, San Francisco, Calif., hepatocyte cells.
University of California, Irvine, Calif., retinal pigment epithelium.
University of Wurzburg, Germany, neuronal cells.
The Scripps Research Institute, La Jolla, Calif., characterization of human parthenogenetic stem cells.
None of these organizations is inaccessible. You can find their phone numbers on the innerwebz, and it has been my experience that scientists are more than happy to tell journalists what's really going on. Oh, well.
Having spent so much time in debunking mode, now I feel like I ought to at least bring you up-to-date on some new developments at ISCO. Several important events have, in fact, occurred lately.
ISCO to Expand Cosmeceutical Product Lines
One, ISCO has been perfecting the process of growing and preserving the active ingredient in parthenogenic stem cells used for their cosmeceutical skin care product line. As a result, they've been able to stockpile enough of the growth factors found in stem cells to allow additional marketing efforts. In the past, availability of product has limited those efforts.
Moreover, the company has announced development of several new skin care products, including one designed to work on the sunken area under the eyes. The skin care line, while not cosmically meaningful, is doing very well for the company and is on track to fund serious work, such as ISCO's liver cell science.
Also, ISCO has brought in an experienced corporate executive to help move the company forward. Dr. Andrey Semechkin, currently CEO, will become co-chairman. Kurt May, currently senior vice president, will take the helm as president and CEO.
From the press release:
"Prior to joining ISCO, Mr. May was a senior executive with GTE Corp. and with PriceSmart Inc., and the founder and CEO of a privately owned biotech company, Psynomics, based on medical technology derived from the University of California, San Diego. Mr. May served as a faculty member and assistant dean of UCSD's Rady School of Management from 2005-09.
"During his tenure as PriceSmart's chief operating officer, Mr. May led the company from startup to growth over three years that included establishing 22 stores in 11 countries, reaching annual revenues of more than $500 million, achieving profitability and expanding staff from 356 to more than 4,200.
"'In addition to its therapeutic programs, ISCO is dedicated to building its revenue-generating subsidiaries to high levels of profitability. We view Mr. May's commercial and entrepreneurial skills as an essential part of our business plan for success,' said Kenneth Aldrich, co-founder and co-chairman of ISCO."
Yours for transformational profits,
Patrick Cox
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©2011 Agora Financial, LLC. All Rights Reserved. Protected by copyright laws of the United States and international treaties. This Newsletter may only be used pursuant to the subscription agreement and any reproduction, copying, or redistribution (electronic or otherwise, including on the world wide web) , in whole or in part, is strictly prohibited without the express written permission of Agora Financial, LLC. 808 Saint Paul Street, Baltimore MD 21202.
Wurzburg, Germany, neuronal cells.
The Scripps Research Institute, La Jolla, Calif., characterization of human parthenogenetic stem cells.
None of these organizations is inaccessible. You can find their phone numbers on the innerwebz, and it has been my experience that scientists are more than happy to tell journalists what's really going on. Oh, well.
Having spent so much time in debunking mode, now I feel like I ought to at least bring you up-to-date on some new developments at ISCO. Several important events have, in fact, occurred lately.
ISCO to Expand Cosmeceutical Product Lines
One, ISCO has been perfecting the process of growing and preserving the active ingredient in parthenogenic stem cells used for their cosmeceutical skin care product line. As a result, they've been able to stockpile enough of the growth factors found in stem cells to allow additional marketing efforts. In the past, availability of product has limited those efforts.
Moreover, the company has announced development of several new skin care products, including one designed to work on the sunken area under the eyes. The skin care line, while not cosmically meaningful, is doing very well for the company and is on track to fund serious work, such as ISCO's liver cell science.
Also, ISCO has brought in an experienced corporate executive to help move the company forward. Dr. Andrey Semechkin, currently CEO, will become co-chairman. Kurt May, currently senior vice president, will take the helm as president and CEO.
From the press release:
"Prior to joining ISCO, Mr. May was a senior executive with GTE Corp. and with PriceSmart Inc., and the founder and CEO of a privately owned biotech company, Psynomics, based on medical technology derived from the University of California, San Diego. Mr. May served as a faculty member and assistant dean of UCSD's Rady School of Management from 2005-09.
"During his tenure as PriceSmart's chief operating officer, Mr. May led the company from startup to growth over three years that included establishing 22 stores in 11 countries, reaching annual revenues of more than $500 million, achieving profitability and expanding staff from 356 to more than 4,200.
"'In addition to its therapeutic programs, ISCO is dedicated to building its revenue-generating subsidiaries to high levels of profitability. We view Mr. May's commercial and entrepreneurial skills as an essential part of our business plan for success,' said Kenneth Aldrich, co-founder and co-chairman of ISCO."
Yours for transformational profits,
Patrick Cox 
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©2011 Agora Financial, LLC. All Rights Reserved. Protected by copyright laws of the United States and international treaties. This Newsletter may only be used pursuant to the subscription agreement and any reproduction, copying, or redistribution (electronic or otherwise, including on the world wide web) , in whole or in part, is strictly prohibited without the express written permission of Agora Financial, LLC. 808 Saint Paul Street, Baltimore MD 21202.

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Stem Cell Agency’s Lobbyist Now Ranked No. 1 in California

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The $3 billion California stem cell agency likes to align itself with the very best science. And as of today it is also hooked up with the best lobbyist in California – at least based on earnings.

CIRM hires many firms to perform work, given its unusual needs, rather than building a large and relatively permanent staff. The tasks of the outside contractors range from publishing the annual report to grant review matters. Today Laurel Rosenhall of The Sacramento Bee reported that one of the firms that CIRM has hired now ranks as the No. 1 lobbyist in California, based on its earnings.

The firm of Nielsen, Merksamer, Parrinello, Gross & Leoni pulled down nearly $5 million during the first three quarters of this year. The firm knocked KP Public Affairs out of the top spot, which it had held for at least the last 10 years.

Nielsen has had a contract with CIRM since its earliest days in 2005, but it doesn't amount to much in the scope of Nielsen's business. According to the latest CIRM report on outside contracting, Nielsen was paid $79,984 during the fiscal year 2010-2011 for services that also extended into the current fiscal year. The report did not list payments for earlier years, but it is our recollection that Nielsen was paid about $50,000 every year since 2005. It is not known whether the firm continues to hold a contract for the current fiscal year.

One of Nielsen's partners, Gene Erbin, was one of the drafters of Prop. 71, the ballot initiative that created the California stem cell agency in 2004. Merck and Pfizer, in addition to CIRM, are among the firm's clients.

Source:
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International Stem Cell Corp. Chairman Kenneth Aldrich Comments on Recent TIME Article “A Stem Cell First: Using the ‘Dolly’ Method on Human Cells”

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“Since we at International Stem Cell Corporation (trading symbol: ISCO.OB) are licensees of some of the key intellectual property necessary to use SCNT in therapeutic products, we were delighted to read about this new discovery.  However, what disappointed us somewhat was the failure of most news reports to mention that a technology already exists that solves the same ethical problems and has the potential also to solve many of the problems of immune rejection that worry scientists who are working with cells obtained from fertilized embryos.
That technology is called "Parthenogenesis" and results in a "cell line" that can provide an essentially unlimited supply of human cells for a wide range of therapeutic purposes, yet does not involve the destruction of any fertilized embryo and results in cells that can be matched to large groups of people who may not even know the patient, much like the way blood from donors can be stored and used by accident victims as needed. Unlike the SCNT cells, parthenogenetic cells require no genetic manipulation or insertion of foreign DNA.
Our scientists at ISCO created and patented the process for making such human parthenogenetic stem cell lines and have already successfully made liver cells, cornea cells, retina cells and nerve cells from those cell lines.  Each of these applications is being studied as a possible future source of transplanted cells to treat diseases such as Parkinson's, Liver Disease, Macular Degeneration, and others. 
To learn more about parthenogenesis, visit our website at http://www.internationalstemcell.com or click on ISCO.OB at any financial web site for information about our company.”
Kenneth C. Aldrich
Chairman
International Stem Cell Corporation
TIME Article – A Stem Cell First: Using the 'Dolly' Method on Human Cells
About International Stem Cell Corporation
International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology, and cell-based skin care products through its subsidiary Lifeline Skin Care. More information is available at http://www.internationalstemcell.com.
To subscribe to receive ongoing corporate communications, please click on the following link:http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0 .
Forward-looking Statements
Statements pertaining to anticipated developments, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates,") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products and the management of collaborations, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.

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International Stem Cell Corporation’s Ken Aldrich Comments on Recent News about SCNT – Somatic Cell Nuclear Transfer

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Last week's newspapers carried the news of what was widely described as a significant “breakthrough” in stem cell science: the first successful human use of a technology known as Somatic Cell Nuclear Transfer (also referred to as SCNT).  This is essentially a variation on a process that was used some years ago to create a cloned sheep named Dolly.  Cloning has since been used commercially in various animal applications.
What is strange about the flurry of publicity about this discovery, however, is the almost total lack of commentary about a method of creating stem cells that has been available to researchers for almost half a decade, holds the same kind of promise as embryonic stem cells for providing cells for the treatment of almost any kind of degenerative disease, is free of ethical issues (including issues with egg donation), and can potentially make immune matched cells available to any patient anywhere in the world, on demand, at a far lower cost.
I am talking about human stem cells derived from a process called, “Parthenogenesis”, developed and first announced in 2007 by a company called International Stem Cell Corporation, whose discoveries were first published in the peer reviewed journal, Cloning and Stem Cells, edited by the scientist who first created “Dolly”, the first cloned animal. 
I realize that I could be accused of bias because I am one of the founders of International Stem Cell, but, in fact, our company also owns license rights to some of the key intellectual property that is required to create cells through SCNT technology and our scientists are very familiar with its promise and its limitations. As a result, International Stem Cell will benefit from the development of either technology, but it is important that the public and the scientific community be fully aware of all alternatives in the field of regenerative medicine, not just the ones that capture public imagination at any particular time.
For that reason, I would like to comment on Parthenogenesis and compare it to SCNT technology and the other options available today. The technology known as "Parthenogenesis" begins with human eggs that are created and used every day throughout the world for in-vitro fertilization (IVF). What is not generally known is that the IVF process can often result in the creation of far more unfertilized eggs than will ever be needed for fertility purposes. It is possible, with informed consent from the IVF patient, to hold back some unfertilized eggs for creation of parthenogenetic stem cells, all at no additional risk to the donor. 
Instead of wasting those eggs, what International Stem Cell does, with the full consent of the donors, is to save those eggs from the trash bin, induce them through a simple, but patented, process to create the small cluster of cells from which a stem cell line can be created that can be used for scientific research and the eventual treatment of patients with such diseases as Parkinson’s, Macular Degeneration, Liver Disease, Diabetes, and possibly many others.
What are critical to understand in thinking about Parthenogenetic stem cells are six things:
Like embryonic stem cells and SCNT cells, these cells can be converted into almost any cell in the human body and thus have enormous potential for human therapy.

Unlike embryonic stem cells, the human eggs used to create parthenogenetic stem cells are never fertilized and cannot become a human being. No viable embryo is ever harmed or destroyed.
Unlike SCNT cells, parthenogenetic stem cells require no genetic manipulation or insertion of foreign DNA.
No donor is every subjected to any additional physical risk beyond what she has already agreed to as part of the IVF procedure in which she elected to participate. In fact, all egg donors voluntarily participate through a very transparent, peer-reviewed, and medically supervised process.  Protocols are approved by Independent Review Boards (IRBs) to protect the safety of donors and by an independent Stem Cell Research Oversight (SCRO) committee to insure compliance with state laws and research ethics, regulations established by the U.S. Food and Drug Administration (FDA) and the U.S. Department of Health and Human Services (HHS) Office for Human Research Protections, in addition to state-level requirements.

The cell lines that are produced from this method, unlike cell lines from embryonic stem cells or from SCNT, can potentially be matched to millions of people in the same way that an organ transplant is matched between donor and patient. In fact, by some estimates, as few as 100 parthenogenetic stem cell lines could provide immune-matched cells to over 50 percent of the world’s population, and could accelerate disease therapies and treatments for severe chronic conditions, including diabetes, spinal cord injuries, liver diseases, blinding diseases such as macular degeneration, and neural diseases such as Parkinson’s and Alzheimer’s.

The possibility of immune-matching to millions of persons can vastly reduce the potential costs relative to SCNT or embryonic stem cell technology, which create stem cell lines that can match only a few persons.
In summary, what we find particularly exciting about Parthenogenesis is that it addresses all the major issues of stem cell therapy. It is free from the traditional bioethical issues that have clouded federal policies towards stem cell research because parthenotes are derived from unfertilized eggs and cannot develop into human beings.  Parthenogenesis is not cloning, and it does not involve the creation or destruction of a viable human life.  Also, the creation of a parthenogenetic stem cell bank will not require a large number of human eggs and many individual donors, as has been a fear surrounding other stem cell approaches.  Parthenogenesis is at once effective and efficient, and one line of parthenogenetic stem cells can be used to create treatments for millions of persons.  This is not a situation where one line must be made for each patient treated.
To learn more about Parthenogenesis, visit http://www.internationalstemcell.com, or click on ISCO.OB at any financial web site for information about our company.

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International Stem Cell’s Research Scientists Successfully Completed the First Series of Preclinical Animal Trials of Neuronal Cells

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International Stem Cell Corporation (OTCBB: ISCO) announces today successful completion of the first series of preclinical studies designed to support the safety and utility of neuronal cells derived from human parthenogenetic stem cell line (hpSC). These initial experiments, demonstrating that the derived neuronal cells were able to survive in mice brains without giving rise to tumors, represent a key milestone towards possible therapeutic applications including treating Parkinson's disease.


Dr. Albrecht Müller, Professor at the Institute of Medical Radiology and Cell Research, Würzburg University (Germany), commented: "Human parthenogenetic stem cells are potentially very promising candidates for use in regenerative medicine primarily because of the possibility that they immune-match a large number of recipients. The result of these safety and survival studies is a very important step along the path towards the clinical use of such cells."


Although most cases of Parkinson's disease occur in people with no family history of the disease, a number of genetic mutations have nevertheless been identified with the disease. While the inheritance pattern is largely unknown, as a condition with a genetic component "autologous" treatment, that is to say treatment using the patient's own cells, is far from ideal and does not offer the potential of a cure. To treat Parkinson's disease successfully a source of cells free of the mutated genes is necessary. Human parthenogenetic stem cells provide this source, as well as superior immune-matching capabilities.


ISCO currently has the world's largest collection of human parthenogenetic stem cells including heterozygous examples, where the cells immune match the donor as is the case with induced pluripotent stem cells (iPS), and homozygous examples which immune-match millions of individuals. ISCO is actively expanding this collection of cell lines and creating a "bank" of homozygous human parthenogenetic stem cells that can be used as a platform to not only reduce the chances of tissue rejection, but also make cellular-based therapies economically more viable.


Dr. Ruslan Semechkin, ISCO's Vice President, commented: "One of ISCO's main therapeutic targets is treatment of Parkinson's disease, a common neurodegenerative disease in the US, where the current standard of care is designed mostly to treat the symptoms, but not the disease. These results clearly represent an important step towards the therapeutic application of human parthenogenetic stem cells derived cells in addressing the basic underlying mechanisms and potentially transforming the treatment of neurodegenerative diseases."


About International Stem Cell Corporation
International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells with minimal immune rejection after transplantation into hundreds of millions of individuals of differing genders, ages and racial background. This offers the potential to create the first true stem cell bank, UniStemCellTM. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology, and cell-based skin care products through its subsidiary Lifeline Skin Care. More information is available at http://www.internationalstemcell.com 


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Forward-looking Statements
Statements pertaining to anticipated developments, research and development goals and related potential therapeutic treatments, the potential benefits of products, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward- looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates,") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products and the management of collaborations, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.


International Stem Cell Corporation
Kenneth C. Aldrich, co -Chairman
760-940-6383
kaldrich@intlstemcell.com
Or:
Dr. Ruslan Semechkin, Vice President
760-940-6383
ras@intlstemcell.com
Or:
Lippert/Heilshorn & Associates
Don Markley
310-691-7100
dmarkley@lhai.com

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International Stem Cell Corporation presents “The Promising Cells” Video

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In this video presentation, see and hear an overview of International Stem Cell Corporation (ISCO.OB). ISCO has developed a process to derive stem cells similar to Embryonic Stem Cells without the need for fertilized embryos and with minimal exposure to non-human cells. These factors provide ISC a unique leadership role in the field of regenerative cell therapy. You'll hear directly from Executive Chairman, Kenneth Aldrich. Lifeline Cell Technology and Skin Care Products, revenue generating units of ISCO are also reviewed.


This presentation was produced by Big Sky Productions, INC (BGSI.OB), Co-Executive Producers Ellis Martin and Bob Lange. 

Unfortunately, this content is currently being updated and will be posted again soon.

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International Stem Cell to Present at the Rodman & Renshaw Annual Global Investment Conference on September 12

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International Stem Cell Corporation (OTCBB: ISCO) announced today that Kenneth Aldrich, Chairman, is scheduled to present at the Rodman & Renshaw Annual Global Investment Conference on Monday, September 12, 2011 at 11:40 a.m. Eastern (8:40 a.m. Pacific). The conference takes place at the Waldorf Astoria Hotel in New York City.
A webcast of the International Stem Cell Corporation presentation can be viewed live at http://www.wsw.com/webcast/rrshq20/isco. The presentation will be archived and available at the same link for 90 days. After the conference, a link to the presentation will also be posted to the ISCO website, http://www.intlstemcell.com.
About International Stem Cell Corporation
International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology, and cell-based skin care products through its subsidiary Lifeline Skin Care. More information is available at http://www.internationalstemcell.com.
To subscribe to receive ongoing corporate communications, please click on the following link: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0.
International Stem Cell Corporation
Kenneth C Aldrich, Chairman
760-940-6383
or
Lippert/Heilshorn & Associates
Don Markley
310-691-7100

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International Stem Cell’s Q2 Revenues Nearly Triple by Deborah Sterescu

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International Stem Cell Corporation (ISCO) (OTCBB:ISCO) reported Wednesday that second quarter sales more than doubled to almost triple, while year-to-date sales jumped a whopping 271%, as the company's operating subsidiaries continue to generate more revenue.
In addition to its hugely potentially valuable stem cell therapy business, the company also two other operations that have reflected revenue growth in the meantime, including Lifeline Cell Technology, which sells its cell-culture products to researchers to grow human cells for pre-clinical research, and Lifeline Skin Care, which sells skin care products based on its parent's stem cell technology.
For the three months ending June 30, International Stem Cell saw revenues rise to $1.1 million, from $0.44 million a year earlier.
Year-to-date revenues totaled $2.6 million, versus $0.7 million for the same period in 2010, helped by a $1.7 million contribution from Lifeline Skin Care, and a $0.9 million addition from Lifeline Cell.
In the last quarter, Lifeline Cell gained over 200 new customers due to new product introductions and the development of distribution channels internationally, a strategy ISCO plans to continue.
Meanwhile, the company's skin care business is coming off a highly successful launch at the end of last year, exceeding its plans to sell 1,000 products, with 7,000 products sold initially. Lifeline Skin plans to aggressively kick start major marketing initiatives again in September.
While these two subsidiaries are busy chalking up revenues, ISCO, whose parthenogenetic stem cell technology can be used to derive pluripotent stem cells, meaning they can be transformed into any cell type in the body, has many important advantages at its fingertips.
Regenerative medicine is a market that is set to boom in the coming years, as more and more companies are developing therapies based on stem cell use. International Stem Cell's long-term goal is to be a universal supplier of stem cells for not just one, but a host of therapies.
The company's parthenogenetic stem cells are derived from unfertilized eggs, avoiding the ethical issues behind the destruction of viable human embryos. Like embryonic stem cells, they also have the capacity to become almost any cell type in the body, but have demonstrated they are better in terms of the immune system, as one single stem cell line can be genetically matched to millions of people, reducing the need for immunosuppressants.
Its plan is to establish a US bank of its clinical-grade human parthenogenetic stem cells that will be capable of being immune-matched to millions of patients, so that a physician could call up and request a specific cell type for people. The company, which recently received approvals to enroll around 3 US donors for its bank, already has a collection of ten human parthenogenetic stem cell lines used for research purposes, which were derived outside the US.
These cell lines could potentially be used to cure a number of diseases, including cancer, heart disease, liver disease, among many others. Already, the company has several trials in the works, and has successfully demonstrated in pre-clinical animal studies that its stem cells can be used to create viable liver cells. It has also started pre-clinical animal trials to create neuronal cells in the brain, to potentially cure Parkinson's disease.
Unsurprisingly, all this work to progress the company's technology has increased expenses, contributing to a $2.5 million loss in the second quarter, or a 3 cent loss per share.
Research and development costs grew on account of greater scientific projects, while general and administrative costs leapt on increased headcount as the company bulks up its management team.
International Stem Cell, with $3.6 million in the bank at the end of the quarter, said that it has not ruled out future capital raising, but it already has a facility that allows it to draw equity as necessary to secure its planned growth.

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