New Article from North County Times – BIOTECH: International Stem Cell Clears Debt, Gets Patent

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By BRADLEY J. FIKES - bfikes@nctimes.com | Posted: June 15, 2010 3:21 pm |

OCEANSIDE ---- For the first time in years, International Stem Cell Corp. has cleared its balance sheet of debt and has enough cash to last for "another year or so," the company's chairman said in a conference call Tuesday.

The improved finances means International Stem Cell can focus more attention on advancing its technology to create stem cells from unfertilized, or "parthenogenetic," human egg cells, said chairman Kenneth Aldrich.

"We've not had that kind of financial security of knowing we could see forward for 12 months without having to go back to the markets since probably the summer of '07, so it's a most welcome change for us," Aldrich said in the conference call.

The company said in a June 14 filing that it struck debt-reduction deals with investors Socius CG II Ltd. and Optimus Capital Partners LLC. The deals exchanged stock previously issued to the investors for promissory notes, with no cash changing hands.

Aldrich said the company reached another important milestone earlier this month when the U.S. Patent and Trademark Office granted it a patent for its parthenogenetic stem cell technology. The patent is the first of several pending, Aldrich said.

Stem cells are the "ancestral" cells that turn in the various kinds of cells in the body. Companies are studying how to use them for disease treatments, or to screen drugs before they're tested in humans.

International Stem Cell says its stem cells have the advantage of being immune-matched to large segments of the population. That means any replacement tissues or organs created from them will be less likely to be rejected after transplant, the company says.

Also, because they are not derived from human embryos, the cells don't raise the ethical issues that concern many about embryonic stem cells, taken from days-old embryos.

The patent, number 7,732,202, applies to the company's method of creating its parthenogenetic stem cells. Other pending patents concern how to make stem cells that can be immune-matched.

International Stem Cell trades over the counter under the ticker ISCO.

Visit http://www.internationstemcell.com or call 760-940-6383.

Call staff writer Bradley J. Fikes at 760-739-6641. Read his blogs at bizblogs.nctimes.com.

SOURCE: http://www.nctimes.com/business/article_7c49ef56-a04f-5cad-98cc-1b99790dc223.html

Heightened Interest from the Medical Research Community and New Funding of International Stem Cell Corporation's (ISCO) Therapeutic Research

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International Stem Cell Corporation (OTCBB: ISCO), http://www.internationalstemcell.com, announced today that the recent presentation entitled "Hepatocyte-like cells derived from patient-specific human parthenogenetic stem cells possess functions of mature human hepatocytes including P450 activity" has been identified as an "AASLD Presidential Poster of Distinction" in the Stem Cells session of The Liver Meeting, the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), in Boston, MA, one of the most prestigious annual medical and scientific conferences. The abstract of the presentation is published in the peer-reviewed supplement to Hepatology, volume 52, number 4 (SUPPL), Oct. 2010, pg 965A, the official journal of the AASLD.

ISCO's CEO Andrey Semechkin, Ph.D., said, "For our cell biologists to have received this award from the leading society in the U.S. focused on treating liver diseases, demonstrates the high caliber of research being carried out at ISCO, and that human parthenogenetic stem cells and their differentiated derivatives are becoming of greater interest to the medical research community as a potential source of therapeutically valuable cells."

ISCO also announced today the initiation of the first in a series of animal studies designed to demonstrate whether hepatocytes and their progenitors derived from the human parthenogenetic stem cells show any disease modifying activity in vivo.

Dr. Nikolay Turovets, ISCO's Director of Research and Therapeutic Development said, "ISCO's continued focus on therapeutic development is critical to show that hepatocytes derived from stem cells can reproduce missing liver function in a diseased organism. Our first series of experiments are designed to test the ability of our cells to engraft and survive in vivo. A second set of experiments will investigate the functional activity of successfully engrafted cells. Data from these studies will also be used to guide the development of future IND submissions."

In other research news, ISCO announced that a grant in which ISCO is a partner, was recently funded by the Qualified Therapeutic Discovery Project Grants Program created under the healthcare reform legislation enacted last March. The study is led by Paul H. Chen, M.D. to investigate healing after corneal surgery using ISCO's corneal epithelial cells developed by ISCO's wholly-owned subsidiary Lifeline Cell Technology. ISCO's cells, combined with a proprietary surgical device developed by Dr. Chen, may provide safer and better long term results than LASIK. By utilizing ISCO's human corneal cells, ISCO and Dr. Chen believe that cellular enhanced PRK could eventually replace LASIK for many of the hundreds of thousands of patients who require corrective eye surgery.

According to Dr. Chen, "This collaborative work with ISCO could lead to a safer and more effective treatment that hopefully will provide quicker visual recovery, less pain, and an improved refractive correction outcome."

ABOUT INTERNATIONAL STEM CELL CORPORATION (ISCO.OB)

International Stem Cell Corporation is a California-based biotechnology company focused on therapeutic and research products. ISCO's core technology, parthenogenesis, results in creation of pluripotent human stem cells from unfertilized oocytes (eggs). These proprietary cells avoid ethical issues associated with use or destruction of viable human embryos and, unlike most other major stem cell types, can be immune matched and be a source of therapeutic cells with minimal rejection after transplantation into hundreds of millions of individuals of differing racial groups. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary, Lifeline Cell Technology, and is developing a line of cosmeceutical products via its subsidiary, Lifeline Skin Care. ISCO is advancing novel human stem cell-based therapies where cells have been proven to be efficacious but traditional small molecule and protein therapeutics have not. More information is available on ISCO's website, 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 therapeutic applications, the potential benefits of collaborations, affiliations, 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" could", "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, uncertainty in the results of clinical trials or 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.

Key Words: Stem cells, parthenogenesis, biotechnology, hepatocytes, liver disease

International Stem Cell Corporation
Jeffrey D. Janus
Sr. Vice President, Operations
1-760-940-6383
jjanus@intlstemcell.coma>
or
Nikolay Turovets, Ph.D.
Director of Research and Therapeutic Development
nturovets@intlstemcell.com

IOM Panel Ends California Visit With No Mainstream Media Coverage

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The blue-ribbon Institute of Medicine panel examining the performance of the $3 billion California stem cell agency has quietly concluded its first public hearing in California without so much as a smidgen of daily coverage in the mainstream media.

Instead, the big state news in California yesterday was a lawsuit filed by lawmakers against the state's top fiscal officer to prevent him from cutting their pay again when they fail to pass a balanced budget.

It would have been extremely unlikely, however, to have seen any daily coverage of the IOM session. The mainstream media generally ignores the affairs of the California stem cell agency.

Other than what has appeared on the California Stem Cell Report, the most comprehensive look at the $700,000, IOM examination of CIRM was provided on Tuesday by Marcy Darnovsky of the Center for Genetics and Society, which has followed CIRM, and the ballot measure that created it, since 2004.

Darnovsky brought her readers on the Biopolitical Times up to speed on CIRM matters. She noted that CIRM will need more cash in a few years when its bond funding runs out. She concluded,

"But ballot measure or no ballot measure, CIRM will continue to disperse the public money it controls - another billion and a half dollars. This is a public agency spending increasingly scarce public resources. It is funding a field of research in which we place great hopes for medical and scientific advances. These factors make it all the more crucial that CIRM follow the basics of good governance and public accountability, and eschew the hyperbole and exaggerated promises that have tainted stem cell research for so long."

The California Stem Cell Report emailed a 1,370-word statement to the panel. The study director of the IOM panel said the statement would be placed in the panel's record.

The document provided perspective on the formation of CIRM, the political context in which it operates and discussed some of the potential pitfalls of CIRM's necessary but delicate courting of industry. Suggestions were offered for changes to ease potential conflicts of interest and to open to the public the statements of the economic interests of the grant reviewers who make the de facto decisions on CIRM's funding.

Here is the full statement from the California Stem Cell Report.
CSCR Statement to IOM-CIRM Performance Inquiry

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

Magazine Survey on CIRM Shows Mixed Results

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The magazine GEN this week produced two relatively lengthy articles dealing with the current state of affairs and the future of the $3 billion California stem cell agency.

Much of the material is familiar to readers of the California Stem Cell Report, but GEN, which says it reaches "221,035 biotech and life science professionals, also produced an online survey that asked its readers: "How helpful has CIRM been in advancing stem cell science?"

At the time of this writing, the results showed that 40.9 of respondents said CIRM was "very helpful."  An identical percentage said "not very" or were undecided. The survey showed 18.2 percent as ranking the agency "somewhat" helpful. The number of respondents was not disclosed.

The two articles (see here and here)by Alex Philippidis also discussed the possibility of a bond issue in a "few years," before CIRM runs out of cash in 2017. Philippidis wrote,

"By then CIRM hopes to have won what ICOC (the CIRM governing board) chairman Jonathan Thomas, Ph.D., has called the 'communications war' the agency is fighting with California newspapers and the CIRM-focused blog California Stem Cell Report. Both have criticized the agency over a host of governance and pay issues."

For the record, the California Stem Cell Report has not criticized the agency in connection with the level of its executive pay. We have pointed out that many California voters have a highly negative and visceral reaction to high public salaries, which is a matter that CIRM must deal with in connection with retention of public confidence. We have also noted that the salaries represent a tiny, tiny fraction of CIRM spending.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

International Stem Cell Corporation Provides Strategic Update on its Skin Care Program

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OCEANSIDE, California - April 8, 2010 - International Stem Cell Corporation (ISCO.OB), http://www.internationalstemcell.com, announces today that it’s wholly owned subsidiary, Lifeline Skin Care Inc., has achieved positive results in human safety tests of its cosmetic products and is moving forward with arrangements with Cosmetic Enterprises Ltd. for the manufacture of three cosmetic products. These developments allow Lifeline Skin Care to plan a launch of its cosmetic product line in the late summer or fall of 2010.

Cosmetic face products developed by Lifeline Skin Care Inc., contain extracts from human parthenogenetic stem cells (hpSC) combined with a vitamin complex and other active ingredients. The products utilize a form of nanotechnology to deliver concentrated active ingredients to damaged skin. Laboratory tests show that an active “complex” of stem cell extract has the ability to rejuvenate skin. Also, early human trials show that these cosmetic products moisturize skin and strongly indicate the ability to decrease the depth of wrinkles and provide factors that lead to anti-aging effects.

Lifeline Skin Care is working with Cosmetic Enterprises, Ltd., located in California, to formulate and package its unique skin care product. Cosmetic Enterprises is a well-known OTC drug licensed manufacturer with over 30 years of experience. Lifeline Skin Care’s “parthenogenetic stem cell complex” the product’s active ingredient, is made in Lifeline Skin Care’s laboratory in Oceanside, California.

According to Gregory S. Keller, MD, FACS, “These positive safety studies in human testing are important, especially considering that preliminary human trial data show that products of the production of International Stem Cell’s parthenogenetic stem cells have significant beneficial effects on the skin and might also provide long term benefits in reducing wrinkles and other visible signs of aging. These results are a significant step forward in making this unique product available to the public.” Dr. Keller was named the 2007 “Specialist of the Year in Facial Cosmetic Surgery” in Strathmore’s “Who’s Who”.

The results of recent human safety tests show there were no identifiable signs or symptoms of sensitization (contact allergy). Safety testing is a series of tests to insure the product does not cause negative reactions such as irritation to the skin. This completed round of testing allows Lifeline Skin Care to move forward confidently with its commercial manufacturing plans.
International Stem Cell Corporation is a pioneer in development of a new class of stem cells called “human parthenogenetic stem cells” which avoid critical ethical issues by eliminating the need to use fertilized embryos and can be immune-matched to large segments of the population. As of today, ISCO has successfully derived 10 hpSC lines. One of these lines (hpSC-Hhom-4), carries the most common immune type found across racial groups within the US population and can be immune-matched to millions of people.

ABOUT INTERNATIONAL STEM CELL CORPORATION (ISCO.OB):
International Stem Cell Corporation is a California-based biotechnology company focused on therapeutic and research products. ISCO’s core technology, parthenogenesis, results in 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 sexes, ages and racial groups. This offers the potential to create the first true stem cell bank, UniStemCell™, while avoiding the ethical issue of using fertilized eggs. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology. More information is available at ISCO’s website, 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 technological developments and therapeutic applications, and other opportunities for the company and its subsidiary, 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," "should," "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, uncertainty in the results of clinical trials or 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 these forward-looking statements.

Key Words: Skin Care, Stem Cells, Biotechnology, Parthenogenesis

CONTACTS:
International Stem Cell Corporation
Kenneth C. Aldrich, Chairman
760-940-6383
kaldrich@intlstemcell.com
Or
Lifeline Skin Care Inc.
Ruslan Semechkin, PhD, CEO
760-940-6383
ras@intlstemcell.com

Short-term Borrowing to Continue to Provide California Stem Cell Cash

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The California stem cell agency will continue to be funded with short-term borrowing -- commercial paper -- provided through the state treasurer's office, J.T. Thomas, chairman of the agency's governing board, said today. 

Until late last year, the $3 billion agency was funded through state bond funds, but California Gov. Jerry Brown is trying to reduce the state's long-term debt load, which has skyrocketed in the last decade. 
Thomas told directors this morning that short-term funding comes at "the lowest possible interest rate." He said the arrangement leaves the agency in "very good shape."
The state will provide the funding to CIRM on a month-to-month basis in addition to providing a two month cushion, Thomas said. 
At some point, the short-term debt is likely to covered by state bonds.  As of June 30, CIRM
had $50.9 million on hand, down $42 million from April 30. During the fiscal year ending June 30, the agency paid out $232.7 million compared to $201.4 million in the previous fiscal year. 

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

The California Stem Cell Agency and the ACT Opportunity

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A promising, positive story on stem cell research in California popped up in the news this week, involving improvements in vision as the result of the only hESC clinical trial in the nation.

The story came after Jonathan Thomas, chairman of the $3 billion California stem cell agency, said in the San Francisco Business Times that what he likes least about his job is that "the coverage in the press chooses to focus on items besides the extraordinary work that our scientists are doing."

The good news about the eye research appeared in the New York Times, Los Angeles Times and across the nation. However, it did not involve work at the stem cell agency, probably for reasons that likely have to do in good part with CIRM. The research involves a firm headquartered in Santa Monica, Ca., Advanced Cell Technology, that moved its base to the Golden State in hopes of securing CIRM funding. ACT has applied more than once for CIRM cash but has never received a grant. And it is one of the rare companies that has complained publicly to the CIRM governing board about a conflict of interest on the part of a CIRM reviewer. In ACT's case, its complaints received a public brushoff at a CIRM board meeting in 2008.

ACT's results in its clinical trial are quite tentative. They involve only two persons. One of the UCLA scientists involved said part of the results could have been the result of a placebo effect. Nonetheless, the reports carried the kind of story line that CIRM yearns for. Indeed, Thomas stressed the need for positive news when he told CIRM directors last June that the agency is in a "communications war" that is tied to its ultimate fate. (The agency runs out of cash in 2017.)

The New York Times' Andy Pollock wrote,

"Both patients, who were legally blind, said in interviews that they had gains in eyesight that were meaningful for them. One said she could see colors better and was able to thread a needle and sew on a button for the first time in years. The other said she was able to navigate a shopping mall by herself."

On its research blog, CIRM described the ACT results as a "milestone." CIRM's Amy Adams wrote,

"It’s the first published paper showing that—at least in this small number of patients for the first few months—the cells are safe."

She quoted Hank Greely of Stanford as saying that the news from ACT is "at least, a little exciting – and in a field that saw its first approved clinical trial stopped two months ago, even a little exciting news is very welcome."

Greely's reference, of course, was to Geron's sudden abandonment in November of its hESC trial, only three months after CIRM gave the firm a $25 million loan. It was widely believed that ACT was one of the initial applicants in the round that provided funding for Geron, although CIRM does not release the names of non-funded applicants.

Last week, CIRM directors spent a fair amount of time discussing the agency's future. The talk was of priorities, hard choices and generating results that would resonate with the people of California.

This week's news from a company that was not funded by CIRM will give them more to ponder.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

Third Researcher Appealing Grant Rejection to Stem Cell Agency Board

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The director of robotics and biosurgery
at UC Davis is appealing rejection of his application for a
$4.9 million grant from the California stem cell agency.

The scientist, W. Douglas Boyd,
noted that his proposal was given a scientific score of 67, which was
one point below the cutoff for most grants approved by CIRM's
Grants Working Group. Thirteen grants fell in the 68 to 53
range, including Boyd's. Reviewers approved four in that range,
including two with scores of 53.
Boyd's letter was brief, focusing on a
letter of support from an Indiana firm, Cook Biotech, Inc.,
that would supply the "material and technical expertise to
create a new bioengineered cardiac patch
material."
The appeal letter, along with other
appeals(see here and here), will be given to CIRM directors in the agenda material for their meeting tomorrow in San Francisco. The
board does not have to act on the petitions or discuss them.
Researchers can also appear before the board to make a case.

Claire Pomeroy, CEO of the UC
Davis Health Systems, is a member of the CIRM board. She
will be barred from taking part in any discussion of Boyd's
application or voting on it.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

California Stem Cell Directors Open Meeting

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Today's session of the governing board of the $3 billion California stem cell agency has begun. The major item on the agenda is a $243 million grant round that has triggered a record pace for appeals by rejected applicants. At the request of the California Stem Cell Report, the agency has provided the conflict of interest list used by the agency to determine which directors will not be allowed today to vote or participate in the discussion of specific applications.  The list can be found below. Conflict of Interest List  -- CIRM Directors Meeting 7-26-12ound below.  

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

Researcher Alert: First Look at Proposed Rules for California's Stem Cell Bank

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The California
stem cell agency today unveiled initial details of how it plans to
run its $30 million bank of reprogrammed adult stem cells.

The proposed
regulations are the first step this year in the $3 billion agency's
project to make IPS cells available worldwide at low cost. It is part
of an effort to stimulate the science and develop commercial cures by
removing research roadblocks.
As Amy Adams,
CIRM's communications manager wrote earlier this year on the agency's research blog,

"One way for CIRM to accelerate research is by creating more of a library system
for stem cells – except we don’t want the cells back."

The agency expects
to issue its first RFA next month in the stem cell banking initiative, which consists of three grant rounds to be approved by
the CIRM board no later than Feburary of next year.

To clear the way
for the first round, CIRM plans to revise its IP regulations to
ensure that they don't hamper the distribution of stem cells in its bank and their wide use.  The revisions will come before the CIRM directors'
IP/Industry Subcommittee next Tuesday. The six-member panel is
co-chaired by co-chaired by Stephen Juelsgaard, former executive vice
president of Genentech, and Duane Roth, CEO of Connect in San Diego,
a nonprofit that supports tech and life sciences entrepreneuers.
Sites where the public can participate in the meeting will be
available in San Francisco, La Jolla, Los Angeles and two in Irvine.
Under the new IP rules, CIRM will retain ownership of the cells in its bank instead
of the grantee, as the current IP rules state.
In a memo to
directors, Elona Baum, general counsel for the agency, said,

"This permits
CIRM to have complete control of this valuable resource and is
consistent with the practice of NIH’s Center for Regenerative
Medicine which is also creating a repository for iPSC lines and
derived materials."

Baum also said,

"The (current) IP
regulations were drafted to address conventional drug discovery
activities and did not contemplate creation of a comprehensive
repository of cell lines intended for broad distribution. As a
result, the IP regulations contain a number of provisions which are
either not applicable or worse could impede the success of the hiPSC
bank. For instance, IP regulations permit the exclusive licensing of
CIRM funded inventions and technology. This would be
counterproductive to the goals of the hiPSC repository which are
predicated on wide spread access."

Baum provided the
following summary of the $30 million banking initiative:

"These lines
will serve as valuable tools in drug discovery and will be available
to researchers worldwide. The Tissue Collection RFA No. 12-02 will
fund clinicians and other scientists to identify, recruit and consent
sufficient numbers of affected individuals within a disease
population so as to effectively represent the disease’s
manifestations. Tissues will be collected and appropriate clinical,
medical or diagnostic information, will be obtained to enable
informed discovery of disease-related phenotypes and drug development
activities using hiPSC-based models. These tissue samples will be
provided (without charge) to the recipient of the CIRM hiPSC
Derivation Award (RFA No. 12-03) for the production of the hiPSC
lines. Once derived, characterized and released, the lines will be
deposited in the CIRM hiPSC bank funded under RFA No. 12-04."

Specific addresses
for the public meeting locations can be found on the agenda.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

Kudos to CIRM: Stem Cell Agency Sticks with Full Financial Disclosure

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A key panel of directors of the $3
billion California stem cell agency yesterday voted unanimously to
retain full public disclosure of the financial interests of its
directors and top executives.
The director's Governance Subcommittee
bypassed a proposal that would have substantially weakened disclosure at a time when the agency is moving closer to industry in an effort
to develop cures.
"Because of CIRM's unique mission
and the agency's longstanding commitment to transparency," said
Kevin McCormack, the agency's spokesman, "they believed that
CIRM should continue to set an example by requiring the broadest
disclosure of members of the board and high level staff."
Currently CIRM board members and top
executives must disclose all their investments and income – in a
general way – along with California real property that they hold.
Under the rejected changes, disclosures would have instead been
required only "if the business entity or source of income is of
the type to receive grants or other monies from or through
the California Institute for Regenerative Medicine." 
The proposed changes would also have
relieved CIRM officials of reporting investment in or income from
venture capital or other firms that may be engaged in financing
biotech or stem cell enterprises, since the firms do not receive cash
from CIRM or engage in biomedical research.

The subcommittee's action will go before the full CIRM board later this month, where it is expected to be ratified. 

Our take? The Governance Subcommittee
took the right action and is to be commended for going beyond the
letter of the law. The integrity and credibility of CIRM are
paramount. As the California Stem Cell Report wrote last week, narrowing disclosure would only have engendered suspicion and
unnecessarily raised questions about the conduct of the agency as it
embarks on an aggressive push for stem cell cures.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

LA Times: Deck Stacked at the IOM Hearing

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The Los Angeles Times web site today carried a sharply worded piece about the upcoming Institute of Medicine hearing on the performance of the $3 billion California stem cell agency.

Written by Pulitzer-prize winning columnist Michael Hiltzik, the item was headlined,

"Stacking the deck on the stem cell program."

The piece referred to Tuesday's meeting of the Institute of Medicine panel looking into the stem cell agency's affairs. The Times article was based largely on a piece yesterday on the California Stem Cell Report that reported that six of the 11 witnesses at the IOM hearing were coming from institutions that had received $418 million from CIRM. The item also reported that the only other witnesses were either CIRM employees or on its governing board.

Hiltzik wrote,

"The insular character of the stem-cell research community always has made objective evaluations of CIRM difficult -- most of the experts in the field are in a position to seek grants from the program or work with it on grant review. The IOM study could have been a counterbalance to that. But that doesn't look like it's about to happen."

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

Conflict of Interest: Chair of California Stem Cell Agency Grant Review Group Resigns

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A conflict of interest on a grant application before the $3 billion California stem cell agency last year led to the resignation of the grant review committee's longstanding chairman, John Sladek of the University of Colorado.

The incident occurred last April but was not publicly disclosed by CIRM until the California Stem Cell Report (CSCR) raised a question earlier this month.

Sladek is professor of neurology, pediatrics and neuroscience at the University of Colorado in Denver and a former president of Cal Lutheran University in the Los Angeles area. He had served on the stem cell agency's grant review group since 2005 and as its chairman from 2009 until April of last year.

Responding to an email from CSCR, James Harrison of Remcho, Johansen and Purcell of San Leandro, Ca., outside counsel to the stem cell agency, said that CIRM's staff uncovered the conflict in April after the grant review session was concluded on March 17. Harrison described it as a "technical violation."

He said,

"While preparing the public summary for Basic Biology III (grant round)applications, CIRM staff discovered that Dr. John Sladek was one of several co-authors on scientific publications with a researcher who was listed as a consultant on a CIRM grant application."

Harrison said,

"This is a technical violation of CIRM's conflict of interest rules, which prohibit a member of the Grants Working Group ("GWG") from participating in the review of an application if the member has co-authored papers with a salaried investigator listed on a CIRM application within a three year window."

Harrison said Sladek's conflict did not violate the state's political reform act nor did he have a financial interest in the application.

Harrison continued,

"Nonetheless, in the spirit of setting an example of strict compliance, Dr. Sladek tendered his resignation from the GWG."

Asked for comment, Sladek said that Harrison's account was accurate and that he had nothing to add. (Both Harrison's and Sladek's verbatim comments can be found here.)

In December, the CIRM board of directors approved, on a unanimous voice vote of the 21 directors present out of 29, a resolution commending Sladek for serving in "exemplary fashion."

The stem cell agency disclosed specifics of the conflict of interest violation after the California Stem Cell Report discovered a vague reference to it in the transcript of the January meeting of the Citizens Financial Oversight and Accountability Committee, the only state entity specifically charged with oversight of the agency and its directors.

Members of the committee had raised questions about conflicts of interests at CIRM. At one point, Harrison said,

"We have also had occasion where we have had a conflict of a very technical nature on the grants working group which we addressed pursuant to our procedure and reported to the legislature."

It was that remark that triggered the request for more details.

Asked about the report to the legislature, Harrison said CIRM wrote a letter to the legislative leadership about the incident. We have asked for a copy of the letter, which we will carry when we receive it.

As of this writing, the review summary for the grant application (RB3-02119) in question was not available on the CIRM web. Normally all the summaries are posted. We have queried the agency concerning its absence.

Harrison also said that in the seven-year history of CIRM no other instances exist of grant review committee members having been determined to be in a conflict of interest after participation in a review.

Our comment: CIRM is to be commended for taking care of this situation quickly last April. Sladek correctly resigned promptly. However, failure to disclose the incident at the time does not reflect well on the California stem cell agency nor does it inspire confidence in the agency's now improving openness and transparency.

CIRM is an enterprise that has substantial built-in conflicts of interests – all legal courtesy of Prop. 71, the ballot initiative that created CIRM. Institutions linked to CIRM directors have received $1.1 billion of the $1.2 billion the agency has given away. A display of reticence in this conflict-of-interest case does little to quell the suspicions of those who have criticized the agency for "cronyism," including the journal Nature and some in the biotech business community and elsewhere. As for the description of the incident as a "very technical" violation, that amounts to a bit of PR. Either it is a violation or it isn't.

Sladek's violation is the sort of thing not well understood by the public. Most public attention is focused on financial conflicts of interest in science. However, professional conflicts of interest involving scientists are among the most invidious. The California Stem Cell Report regularly hears complaints and suspicions about such dealings at CIRM: Big-name scientists receiving favored treatment, academic researchers unfairly evaluating applications from business researchers, younger researchers being shunted to background and more. All this as a billion dollars worth of applications have been evaluated behind closed doors with no public disclosure of the economic or professional interests of the reviewers. The stem cell agency would do well to improve its openness and transparency, particularly as it moves into ticklish and expensive relationships with industry. The first step would be to post on its web site the disclosure forms filed by its grant reviewers but withheld from the public by CIRM.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

Conflict of Interest: California Stem Cell Agency Releases More Documents in Sladek Violation

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The California stem cell agency today released its letter to leaders of the California legislature concerning the conflict of interest violation by the scientist who was then chairman of the panel that makes the de facto decisions on hundreds of millions of dollars in research grants.

The agency also posted the review summary of the application involved in the conflict of interest, which had been missing from its web site.

The incident occurred last April, but was not publicly disclosed by the $3 billion research enterprise until questions were raised this month by the California Stem Cell Report. The case involved John Sladek of the University of Colorado in Denver, then chairman of the CIRM grant review group, which makes decisions on the hundreds of grant applications. The CIRM board of directors has final approval but it almost never overturns a favorable recommendation from the grant panel.

Sladek resigned from the review group after CIRM staff discovered the conflict following the March 17 review session. CIRM called it a "technical violation."

The information provided today by CIRM added some details to the matter, including Sladek's statement that the conflict was inadvertent on his part.

The June 15 letter to the speaker of the state Assembly and the leader of the state Senate was labelled "confidential disclosure." Signed by then CIRM Chairman Robert Klein, it said,

"While preparing the public summary for Basic Biology III Awards Application No. RB3-02119, CIRM staff discovered that Dr. Sladek had co-authored two papers in the last three years with a researcher on the application. Although the researcher’s name was included on the CIRM conflict of interest form, Dr. Sladek did not disclose these publications to CIRM."

As reported earlier, Sladek's participation did not affect the outcome on the application, which was not recommended for funding.

As is CIRM's practice, the review summary of the grant application did not identify the scientist seeking funding. The summary listed one reviewer with an unspecified conflict, Ali Brivanlou of Rockefeller University.

The letter was provided by CIRM at the request of the California Stem Cell Report, which also asked for the review summary of the grant application after discovering it was missing. James Harrison, outside counsel to the agency, said in an email that the summary was not posted because of a "programming error."

The summary can be found here. Here is the letter.Sladek/CIRM Conflict of Interest Letter to California Legislative Leadership

Source:
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International Stem Cell Corporation Launches New Marketing Campaign for Lifeline Skin CareTM Products

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International Stem Cell Corporation (OTCBB: ISCO) today announced the Company's near-term marketing plans for products manufactured by its Lifeline Skin Care™ (Lifeline) subsidiary. Following the highly successful launch in late 2010 of Lifeline's first two products with sales that greatly exceeded expectations, Lifeline has now commenced a new phase in the marketing plan for its skin care products.

The first step in these initiatives is a series of briefings being conducted in New York City this week with editors at beauty magazines whose readership reflects the target user base for Lifeline's anti-aging skin care products. This will be followed by a series of targeted email offerings developed by Lifeline's marketing partner, The Mauldin Companies, culminating in a larger offering in June.

Lifeline's anti-aging products were developed by ISCO's scientific research team in collaboration with internationally recognized cosmetic experts. The first two products, a Day Serum and a Night Serum, both contain an extract from ISCO's proprietary human parthenogenetic stem cells which, in combination with vitamin complexes, provides major rejuvenating effects, including improvement in skin tone and elasticity, and improvement in the appearance of fine lines and wrinkles. These effects have been substantiated by clinical studies performed at industry-leading independent testing organizations.

Lifeline's premium product line includes the Recovery Night Moisture Serum and the Defensive Day Moisture Serum/SPF-15. These products are most commonly ordered together in a 2-pack, and can be purchased by visiting Lifeline's website athttp://www.lifelineskincare.com. The products are also available at selected luxury spas and physician's offices in the United States.

Dr. Ruslan Semechkin, President and CEO of Lifeline Skin Care, added that Lifeline plans to launch additional skin care products later this year, including an eye cream formulated with a proprietary stem cell derivative and a cleanser.

Lifeline is focusing its marketing on direct-to-consumer channels to highly targeted audiences with traditional print and media promotions planned for later in the year. The Company's goal is to generate favorable word-of-mouth through a network of satisfied customers, thereby building a community of users based on their shared experience of success with Lifeline's proprietary anti-aging products.

Ken Aldrich, Co-founder and Chairman of Lifeline's parent company, International Stem Cell Corporation, said, "The success of Lifeline Skin Care demonstrates that we can make a positive difference in people's lives today, while also providing an important source of revenue to support ISCO's development of stem cell therapies that may in the future result in treatment for many widespread human 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, 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, product introduction and marketing plans and related support, 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.

http://cts.businesswire.com/ct/CT?id=bwnews&sty=20110512005363r1&sid=14230&distro=ftp

International Stem Cell Corporation
Kenneth C Aldrich, Chairman
760-940-6383
kaldrich@intlstemcell.com
or
Lifeline Skin Care, Inc.
Ruslan Semechkin, Ph.D., President & CEO
Vice President, ISCO
ras@intlstemcell.com
or
Lippert/Heilshorn & Associates
Don Markley
310-691-7100
dm
arkley@lhai.com

State Controller to Hold Hearing on Stem Cell Agency Finances

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The only state body specifically charged with oversight of the $3 billion California stem cell agency and its board will meet next Friday in Los Angeles for a look at the enterprise's financial affairs.

The group is the Citizens Financial Accountability and Oversight Committee, chaired by the state's top fiscal officer, Controller John Chiang. It was created by Proposition 71, the ballot initiative that established the stem cell research effort.

The agenda is a tad shy of details on what is likely to be brought up although it does mention a briefing by CIRM on "CIRM’s financial performance, current budget,update of grants awarded and grant process."

CIRM Chairman Jonathan Thomas is expected to attend along with the agency's new and first chief financial officer, Matt Plunkett.

Source:
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"A Little Egg On the Face" – LifeLine Skin Care Stem Cell Cream Article

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"A Little Egg On the Face" by Rebecca Tolin (read San Diego Magazine article here )

Women have been known to slather their faces with fruit, fish oil, foreskin (uh huh, the target of circumcision) and even the neurotoxin that causes botulism?—?all in the name of looking pretty. Now an Oceanside biotech has another novel ingredient for the aging-averse: stem cells from unfertilized human eggs.

“It’s not like a woman donated eggs in Encinitas and three months later it’s in someone’s skin in L.A.,” explains Brian Lundstrom, president of International Stem Cell Corporation (ISSC) in Oceanside, parent company of Lifeline Skin Care. It’s more like this: Women go to in-vitro fertilization clinics to get pregnant. There are often leftover eggs from that process. Researchers select stem cells, grow billions of them, and extract the bits that skin loves, such as growth factors?—?with permission from the donors, of course. Scientists then whip ’em up with antioxidants and sell the stuff in a slick plastic tube for about the cost of a month’s supply of Frappuccinos.

Is this a noncaffeinated fountain of youth? Ruslan Semechkin, the CEO of Lifeline and a biologist by training, says an eight-week study showed the day-and-night serum combo reduced the number and depth of wrinkles and made skin brighter, tighter and moister?—?though he wouldn’t say by how much. (Semechkin is 25, has the olive-tinged skin of a baby and admits a complexion of his variety doesn’t need this heavy hitter.)
Even in the stem cell world, youth is coveted. Lundstrom says stem cells taken from unfertilized eggs?—?the very seeds of life?—?are the youngest around and can become any cell in the human body. This is the first time such stem cell fragments have found their way into beauty cream, he explains. And because the eggs aren’t fertilized, they bypass the embryo controversy.

Someday, movement in the paralyzed and memory in the aged could be restored by using such cells; ISSC has already grown a human cornea that could cure blindness in people with eye damage. These breakthroughs may be dec­ades away, but ISSC’s “cosmeceuticals” are just the beginning. Profits from pocketbooks of the age-obsessed will fund the biotech’s research for other therapeutic drugs. So if you’re considering spending a small fortune to plump things up, you could call it a contribution to science.

Lifeline Defensive Day Moisture Serum sells for $155 and Lifeline Recovery Night Moisture Serum costs $185. It’s available at lifelineskincare.com.

Prostate CSCs sensitive to gamma-tocotrienol?

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Gamma-Tocotrienol Kills Prostate Cancer Stem Cells, PRNewswire, July 25, 2010. Excerpt:

The scientists found that low doses of gamma-tocotrienol cause apoptosis in the prostate cancer stem cells and suppress their colony formation capability. This results in a lower prostate cancer stem cell population (as defined by the protein markers CD133 and CD44). Further tests in mice models were conducted, where mice implanted with hormonal refractory prostate cancer cells were given gamma-tocotrienol orally. The results showed that gamma- tocotrienol not only reduced tumour size formed, but also decreased the incidence rate of tumour formation by 75%, as compared to the control group of mice, which had 100% tumour formation. These results strongly suggest that gamma-tocotrienol could be developed for prostate cancer prevention and treatment.

The news release by Davos Life Science is based on the publication:

Gamma-tocotrienol as an effective agent in targeting prostate cancer stem cell-like population by Sze Ue Luk and 11 co-authors, including Ming-Tat Ling, Int J Cancer 2010(Jul 8) [Epub ahead of print][PubMed citation].

Comment:

See also a relevant patent application: (WO/2010/047663) Use of Tocotrienol Composition for the Prevention of Cancer.
Publication Date: 29.04.2010
Applicants: DAVOS LIFE SCIENCE PTE. LTD. [SG/SG]; 16 Tuas South Street 5 Singapore 637795 (SG) (All Except US).
LING, Ming Tat [CN/AU]; (AU) (US Only).
YAP, Wei Ney [MY/SG]; (SG) (US Only).
WONG, Yong Chuan [MY/CN]; (CN) (US Only).
YAP, Yee Leng, Daniel [MY/SG]; (SG) (US Only).

International Stem Cell Corporation and Sristi Biosciences Enter Distribution Agreement for Lifeline Cell Technology's Brand of Human Cell Culture…

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International Stem Cell Corporation (OTCBB:ISCO), http://www.internationalstemcell.com, via its wholly-owned subsidiary, Lifeline Cell Technology® (Lifeline) http://www.lifelinecelltech.com, and Sristi Biosciences, http://www.sristibio.com, have entered into a distribution agreement for the Lifeline® brand of human cell culture products in India.

Lifeline specializes in development, manufacture and distribution of primary human cells and media and growth factors for optimized culturing of cells, including stem cells. These products are being requested by customers internationally, including in India, which represents one of the fastest growing markets for products of this kind.

According to Lifeline's CEO and SVP of Operations at ISCO, Jeffrey Janus, 'Sristi Biosciences is part of one of the most experienced biotechnology companies in India and the first to advance cell therapy into human trials in that country. Their network among academic and corporate researchers and experience and capacity to import and handle primary cell cultures, media and growth factors in India will be highly valuable for Lifeline to continue the international commercial expansion of its brand.'

Lifeline's scientists have over 20 years of experience developing products for the culture of human cells. The company has made significant contributions to the creation and standardization of human cell systems used today for clinical applications and in academic, government and pharmaceutical research laboratories. The group sells over 75 standardized products directly and via its distributors in the US and abroad. It also engages in customized product development for its largest customers.

Dr. Sudhir Reddy, Sristi Biosciences' CEO adds, 'We are pleased to be the first company to introduce the Lifeline products to the growing Indian research market. Our cell culture experience and broad market reach in India will benefit the brand and help Sristi Biosciences further accelerate its commercialization and corporate growth in the biomedical field.'

ISCO recently announced the beginning of a collaboration on its human corneal tissue, CytoCor™, with leading Indian eye hospital and research center, Sankara Nethralaya, and Letter of Intent with Insight Bioventures India (IBVI) to seek funding and establishment of development and manufacturing operations for ISCO's research and pharmaceutical products in India (ISCO India), including the Lifeline products and CytoCor.

'The Lifeline distribution agreement with Sristi Biosciences is central to ISCO's international expansion. Besides facilitating commercialization of the Lifeline products in India, Sristi Biosciences' cell therapy development, regulatory and manufacturing expertise will be important as ISCO and IBVI seek to establish ISCO India with cost-efficient development and manufacturing of research and pharmaceutical products for the Indian and broader Asian markets,' says Brian Lundstrom, ISCO's President.

ABOUT INTERNATIONAL STEM CELL CORPORATION (ISCO.OB)

International Stem Cell Corporation is a California-based biotechnology company focused on therapeutic and research products. ISCO's core technology, parthenogenesis, results in creation of pluripotent human stem cells from unfertilized oocytes (eggs). These proprietary cells avoid ethical issues associated with use or destruction of viable human embryos and, unlike most other major stem cell types, can be immune matched and be a source of therapeutic cells with minimal rejection after transplantation into hundreds of millions of individuals of differing racial groups. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary, Lifeline Cell Technology, and is developing a line of cosmeceutical products via its subsidiary, Lifeline Skin Care. ISCO is advancing novel human stem cell-based therapies where cells have been proven to be efficacious but traditional small molecule and protein therapeutics have not. More information is available on ISCO's website.

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.

ABOUT SRISTI BIOSCIENCES

Sristi Biosciences Private Limited is a result of twelve years of research and corporate development in the therapeutic space and is the healthcare component of leading biotechnology group, SRI Biotech, in India. Sristi Biosciences' two main divisions include Tissue Engineering and Cell Therapy that has pioneered chondrocytes-based cell therapy in India and Drug Discoverythat covers the Indian research product market with natural compound libraries, molecular diagnostics and markers, informatics and cell-based products. Sristi's integrated research and development facility in Hyderabad is state-of-the-art and the company has wide collaborative and commercial presence across the research market in India, including 23 leading biotech institutes and major corporate bodies.

FORWARD-LOOKING STATEMENTS

Statements pertaining to anticipated developments and therapeutic applications, the potential benefits of collaborations, affiliations, 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, uncertainty in the results of clinical trials or 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.

Key Words: Stem Cells, Biotechnology, Parthenogenesis

International Stem Cell Corporation
Kenneth C. Aldrich, Chairman
760-940-6383
kaldrich@intlstemcell.com
Or
Brian Lundstrom, President
760-640-6383
bl@intlstemcell.com