CALGARY , June 13, 2012 /CNW/ - Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) announced today that a paper entitled "Cell Carriage, Delivery, and Selective Replication of an Oncolytic Virus in Tumor in Patients," has been published in the latest issue of the journal Science Translational Medicine (Vol. 4 Issue 138 138ra77).

The paper covers findings from a U.K. translational clinical trial (REO 013) investigating intravenous administration of REOLYSIN in patients with metastatic colorectal cancer prior to surgical resection of liver metastases. The paper was jointly first-authored by researchers from the Leeds Institute of Molecular Medicine, University of Leeds , UK and The Institute of Cancer Research, London , UK.

The trial was an open-label, non-randomized, single centre study of REOLYSIN given intravenously to patients for five consecutive days in advance of their scheduled operations to remove colorectal cancer metastasis in the liver. Ten patients were treated with intravenous REOLYSIN at 1x1010 TCID50, one to four weeks prior to planned surgery. After surgery, the tumor and surrounding liver tissue were assessed for viral status and anti-tumor effects.

The researchers demonstrated that even though all the treated patients had preexisting immunity to the virus, intravenously administered reovirus could still specifically target and infect metastatic liver tumors in 90% of the patients. The researchers were able to determine that reovirus was able to evade these neutralizing effects of the immune system by binding to specific blood cells that would in turn deliver the virus to the tumor. Analysis of surgical specimens demonstrated greater, preferential expression of reovirus protein in malignant cells compared to either tumor stroma or surrounding normal liver tissue. There was evidence of viral factories within tumor and recovery of replicating virus from tumor (but not normal liver) in all four patients from whom fresh tissue was available. This is the first time that researchers have been able to demonstrate in patients treated with intravenously delivered oncolytic virus, that a virus could cloak itself from neutralizing antibodies after systemic administration through blood cell carriage and specifically target tumor tissue.

"These are key findings that directly further our understanding of how REOLYSIN interacts with the human immune system and retains its cytotoxicity in the body following intravenous administration," said Dr. Brad Thompson , President and CEO of Oncolytics. "It also highlights the reovirus' unique ability to target cancer cells, and create viral factories within tumor cells, without harming normal, healthy tissue."

"We believe this trial is a key step forward for virotherapy," said Dr. Alan Melcher , Professor of Oncology and Biotherapy at the University of Leeds , UK. "For the first time it shows in patients that intravenously injected reovirus selectively targets cancer, but not normal tissue, for replication and tumor cell killing. It also shows that even when anti-viral antibodies are present in the circulation, the virus can evade neutralization by "hitch-hiking" on blood cells to reach its tumor target."

One of the UK's largest medical, health and bioscience research bases, the University of Leeds delivers world leading research in medical engineering, cancer, cardiovascular studies, epidemiology, molecular genetics, musculoskeletal medicine, dentistry, psychology and applied health. Treatments and initiatives developed in Leeds are transforming the lives of people worldwide with conditions such as diabetes, HIV, tuberculosis and malaria. http://www.leeds.ac.uk.

The Institute of Cancer Research (ICR) is one of the world's most influential cancer research institutes. Scientists and clinicians at the ICR are working every day to make a real impact on cancer patients' lives. Through its unique partnership with The Royal Marsden Hospital and 'bench-to-bedside' approach, the ICR is able to create and deliver results in a way that other institutions cannot. Together the two organisations are rated in the top four cancer centres globally. The ICR has an outstanding record of achievement dating back more than 100 years. It provided the first convincing evidence that DNA damage is the basic cause of cancer, laying the foundation for the now universally accepted idea that cancer is a genetic disease. Today it leads the world at isolating cancer-related genes and discovering new targeted drugs for personalised cancer treatment. As a college of the University of London , the ICR provides postgraduate higher education of international distinction. It has charitable status and relies on support from partner organisations, charities and the general public. The ICR's mission is to make the discoveries that defeat cancer. For more information visit http://www.icr.ac.uk.

The Royal Marsden NHS Foundation Trust The Royal Marsden opened its doors in 1851 as the world's first hospital dedicated to cancer diagnosis, treatment, research and education. Today, together with its academic partner, The Institute of Cancer Research (ICR), it is the largest and most comprehensive cancer centre in Europe treating over 44,000 patients every year. It is a centre of excellence with an international reputation for groundbreaking research and pioneering the very latest in cancer treatments and technologies. The Royal Marsden also provides community services in the London boroughs of Sutton and Merton and in June 2010 , along with the ICR, the Trust launched a new academic partnership with Mount Vernon Cancer Centre in Middlesex. Since 2004, the hospital's charity, The Royal Marsden Cancer Charity, has helped raise over 50 million to build theatres, diagnostic centres, and drug development units. Prince William became President of The Royal Marsden in 2007, following a long royal connection with the hospital. For more information, visit http://www.royalmarsden.nhs.uk.

About Oncolytics Biotech Inc. Oncolytics is a Calgary-based biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics. Oncolytics' clinical program includes a variety of human trials including a Phase III trial in head and neck cancers using REOLYSIN, its proprietary formulation of the human reovirus. For further information about Oncolytics, please visit: http://www.oncolyticsbiotech.com.

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Oncolytics Biotech® Inc. Announces Publication of Translational Clinical Trial Results in Science Translational Medicine

Newswise Bethesda, MD, June 13, 2012: the Association for Molecular Pathology (AMP) announced a record-breaking number of abstract submissions for the AMP 2012 Annual Meeting on Genomic Medicine, marking a 40% increase over last year. The Meeting will be held October 25-27, 2012 in Long Beach, CA. An increase in the number of meeting attendees and exhibitors is anticipated as well. "The record growth in every phase demonstrates clearly how well-recognized it is that AMP offers the meeting of the year in molecular diagnostics and genomics," stated Iris Schrijver, MD, AMP President.

Growth in recent years and the spike in this years AMP Annual Meeting participation mirror the marked growth in the field of molecular pathology. AMP has had consistent growth in the number of abstracts submitted and number of attendees at the annual meeting, but the increase this year blew the lid off even our expectations, noted Mary Steele Williams, Executive Director, The AMP 2012 Annual Meeting on Genomic Medicine promises to be jam-packed with attendees and exciting scientific exchange.

As the only organization dedicated solely to the practice and science of molecular pathology, it is natural that the AMP Annual Meeting serves as the showcase for translational research, clinical practice, and practical technical discussions in all aspects of molecular diagnostics and genomic medicine. Abstract topics submitted for this years meeting span the breadth of molecular diagnostics, including the use of next generation sequencing in a clinical setting; novel tools for the detection of infectious agents; development and validation of new molecular tests; detection and analysis of various biomarkers in cancer.

Session topics chosen for this years meeting include; integrating pharmacogenomics into health care, utility of next generation sequencing, new molecular pathology CPT codes, and many more. AMP expects a record number of poster presentations at this years AMP Annual Meeting. With 400+ posters plus more than 30 hours of educational sessions and 55 presentations, this years event is expected to be the largest to date.

ABOUT AMP: The Association for Molecular Pathology (AMP) is an international medical professional association dedicated to the advancement, practice, and science of clinical molecular laboratory medicine and translational research based on the applications of molecular biology, genetics, and genomics. For more information, please visit http://www.amp.org.

CONTACT: Mary Steele Williams mwilliams@amp.org (301) 634-7921

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AMP Receives 40% Increase in Abstract Submissions

OTTAWA The Ottawa Hospital is looking to gain a foothold in the fast-growing field of personalized medicine, which involves using gene sequencing to help doctors predict which drugs would work best for a particular patient.

The hospital has drawn up plans to set up a molecular diagnostics lab with the technology to decode hundreds of genes, or even the entire genomes of patients, which could yield new approaches for treating cancer and other serious diseases.

Details of the plan are still being worked out, and no funding has yet been committed to the project. The hospital is looking to raise $380,000 in seed money to get the lab off the ground. Another $1 million would have to be raised to buy the gene-sequencing equipment.

Hospital officials say the lab would mark a key step in making the relatively new technology of DNA sequencing a standard part of medical care. It would also position the hospital for an emerging field in which the medical establishment has placed great hope: studying entire genomes all of a patients DNA and identifying every mutation involved in a particular disease.

Experts say the approach would enable treatments to be customized to an individual patients genetic profile, which is miles away from the traditional trial-and-error method of giving every patient the same drugs in the hope of benefiting the fortunate few.

Down the road, the hospital wants to establish a teaching program that would train a new generation of pathologists with the skills to practise personalized medicine.

This is a very realistic vision, and I want Ottawa to be positioned as a provincial centre of excellence for molecular diagnostics, said Paula Doering, the hospitals vice-president of clinical programs.

Currently, the use of gene sequencing is most advanced in cancer care. Doctors use the information to guide more precise treatment, or to tailor drugs to the genetic traits of patients, with the goal of giving them a better chance of survival.

The idea is to avoid wasting precious time and money on potentially ineffective treatments, which expose countless patients to harmful side effects and inflate the nations drug spending.

Of the 7,000 cancer patients who are treated annually at The Ottawa Hospital, a high proportion receive testing for selective genes or chemical markers, especially if they have certain types of breast, lung, colorectal or gastrointestinal cancer, said Dr. David Stewart, the hospitals head of medical oncology.

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Ottawa Hospital eyes expansion into cutting-edge ‘molecular medicine’

ImmunoSPECT imaging shows that the effectiveness of a newly developed radioimmunotherapy for treating a resistant form of kidney cancer could be diminished when used after another anti-cancer therapy.

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Molecular Imaging Informs Kidney Cancer Treatment

Public release date: 11-Jun-2012 [ | E-mail | Share ]

Contact: Susan Martonik smartonik@snm.org 703-652-6773 Society of Nuclear Medicine

Miami Beach, Fla. (June 11, 2012)A method of molecular imaging that pinpoints hormonally active tissues in the body could change the course of treatment for a remarkable number of neuroendocrine cancer patients, say researchers at the Society of Nuclear Medicine's 59th Annual Meeting.

An investigation of a molecular imaging method used to evaluate neuroendocrine patients prior to treatment was found to change management in more than 35 percent of the patients following imaging.

Patients who were previously considered inoperable went on to have surgery, and patients with previously unknown and extensive cancer who were originally slated for surgery were considered inoperable. Ruling out surgery in cases that are unlikely to be treated successfully with resection saves patients from the stress and potential complications of unnecessary surgeries.

"The study shows that this particular molecular imaging technique does significantly change patient management, identifying operable and curable symptomatic patients or sparing patients from futile surgery," says Niklaus Schaefer, M.D., lead investigator at the University Hospital of Zurich in Zurich, Switzerland. "The positive impact on our patients is also significant. This serves as a model for further use of molecular imaging to assess neuroendocrine tumors."

Neuroendocrine tumors originate from cells of the neuroendocrine system, which regulates the effect of hormones in various organs throughout the body where hormones are active. This is especially the case in the lungs and gastrointestinal tract, where the rates of respiration and digestion are moderated by hormones. Many of these cancers are asymptomatic and metastatic, which means they can develop unnoticed and spread from their original location to other tissues and organs. Clinical decision-making can be a challenge when determining the most appropriate treatment for patients with these cancers.

In this study, investigators were looking at a molecular imaging method that combines positron emission tomography (PET), which provides information about physiological processes in the body, and computed tomography (CT), ideal for imaging structure. PET/CT was performed in conjunction with injection of an imaging probe that works by combining the radionuclide Gallium-68 (Ga-68) with a molecular compound that mimics hormones called somatostatins that regulate the neuroendocrine system. Upon injection, the probe begins interacting with neuroendocrine cellsespecially those within cancerous tumors, because they are more active than healthy cells. These biological processes show up as "hot-spots" on PET scans, letting clinicians know where neuroendocrine cancer is proliferating.

Results of the study indicated that PET/CT and Ga-68 DOTATATE was highly sensitive and specific for assessing neuroendocrine tumors and changed the course of treatment for a large number of patients. Prior to imaging, more than half of the 61 patients who were picked for the study were considered eligible for surgery to remove their cancer. The remaining 29 were determined to be inoperable. Subjects were then imaged using Gallium-68 DOTATATE PET/CT. After molecular imaging, about 36 percent of patients had a change in their management. Of those who were originally classified as operable, 14 were subsequently considered ineligible for surgery. For patients who were at first considered inoperable, 8 patients went on to have surgical resection of their tumors.

"This is the first prospective trial investigating the role of Gallium-68 DOTATATE in a multidisciplinary clinical setting and its impact on further patient management," says Schaefer. "Molecular imaging with this biomarker is already available in several centers around the world, and expansion of its use has the potential to help these patients and their treating physicians, who can use it to set up a clinical plan in one single investigation."

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PET imaging could lead to better care for neuroendocrine cancer

ScienceDaily (June 11, 2012) Out of control competitive aggression could be a result of a lagging neurotransmitter called dopamine, say researchers presenting a study at the Society of Nuclear Medicine's 2012 Annual Meeting. During a computer game against a putative cheating adversary, participants who had a lower capacity to synthesize this neurotransmitter in the brain were more distracted from their basic motivation to earn money and were more likely to act out with aggression.

For many people, anger is an almost automatic response to life's challenges. In clinical psychiatry, scientists look at not only the impact of aggressive behavior on the individual, their loved ones and the community but also the triggers in the brain that lead to aggressive response. The neurobiology of aggression is not well understood, but scientists are aware of a relationship between the neurotransmitter serotonin and certain aggressive behaviors. The objective of this study was to explore whether higher levels of another brain chemical called dopamine, involved in pleasure and reward, increased aggressive response in its subjects. To scientists' surprise, it was not as they first theorized.

"The results of this study were astonishingly opposite of what was previously hypothesized," says Ingo Vernaleken, M.D., lead author of the study and research scientist for the department of psychiatry at RWTH Aachen University in Aachen, Germany. "Subjects with more functional dopaminergic reward-systems were not more aggressive in competitive situations and could concentrate even more on the game. Subjects with lower dopaminergic capacity were more likely to be distracted by the cheating behavior."

In this study, 18 healthy adults in their twenties were tested for aggression using the psychological behavioral task known as the point subtraction aggression paradigm (PSAP). Participants were asked to play a computer game that required them to press a bar multiple times with the incentive of winning money, but they were also told that an adversary in the next room who is able to cheat may steal some of their winnings. What the paranoid participants did not know was that there was no adversary. The computer program is designed to perform randomized deductions of the subjects' monetary reward to simulate the cheating competitor.The participant had three choices to react: punish the cheater, shield against the adversary by repeatedly pressing a defense button, or continue playing the game in order to maximize their ability to win cash, which indicated resilience.

"The PSAP focuses on aggressive reaction within a competitive situation," says Vernaleken. "Aggression and its neurobiological mechanisms in humans have been only moderately investigated in the past. Furthermore, most of the previous studies mainly covered the more reactive part of aggression, which merely reflects impulsive behavior and appears to be associated merely with the serotonin system. This investigation focuses on the association with the dopaminergic reward-system, which reflects goal-directed aggression."

Subjects' brains were imaged using positron emission tomography, which provides a range of information about physiological functions inside the body, depending on the imaging probe used. In this investigation, F-18 FDOPA, a biomarker that lights up enzymes' ability to synthesize this transmitter, was used and the uptake of this drug in the brain was analyzed to gauge the correlation between the participants' dopamine synthesis capacity and aggressive behavior.

Results of the study showed a significant impact on aggressive response in areas in the brain where dopamine synthesis was present, especially in the basal ganglia, which among other functions include the motivation center. Minimized aggression was associated with higher dopamine levels in both the midbrain and the striatum, which plays a role in planning and executive function. People with greater capacity for dopamine synthesis were more invested in the monetary reward aspect of the PSAP, instead of acting in defense or with aggression against their perceived adversary, whereas subjects with lower capacities had a higher vulnerability to act either aggressive, defensive or both.

"Thus, we think that a well-functioning reward system causes more resilience against provocation," says Vernaleken. "However, we cannot exclude that in a situation where the subject would directly profit from aggressive behavior, in absence of alternatives, the correlation might be the other way around."

Further research is required to explore the link between dopamine and a range of aggressive behavior. More insight into these relationships could potentially lead to new psychological therapies and drug treatments to moderate or prevent aggressive response.

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Molecular imaging finds link between low dopamine levels and aggression

Public release date: 11-Jun-2012 [ | E-mail | Share ]

Contact: Susan Martonik smartonik@snm.org 703-652-6773 Society of Nuclear Medicine

Miami Beach, Fla. (June 11, 2012)Patients with cardiovascular disease will now benefit from a powerful new molecular imaging tool to detect disease in the main arteries supplying oxygen to the heart, say researchers presenting studies at the Society of Nuclear Medicine's 2012 Annual Meeting.

When an active heart needs more oxygen, blood vessels have a natural ability to open more so that greater amounts of blood can flow. The maximum dilation possible is the coronary flow reserve or CFR. This is an important reference, because it is one of the earliest signs of coronary artery disease, which is caused by atherosclerosis, a narrowing or hardening of these arteries due to a build-up of cholesterol and scar tissue. Diseased coronary arteries are unable to dilate as fully as healthy blood vessels, potentially limiting oxygen supply to the heart muscle.

The World Health Organization considers cardiovascular disease the number one cause of death and disability across the globe. Coronary artery disease is just one of a range of these diseases that can cause serious problems, including heart attack, if left untreated.

In two studies presented at the meeting, investigators examined quantitative imaging data to determine the true extent of coronary artery disease. In one study, researchers tested a molecular imaging method called myocardial perfusion imaging, also known as a stress test, conducted with positron emission tomography (PET). They then measured the CFR and calculated the precise dilation of blood vessels at rest and under stress. The objective of the study was to compare this technique's ability to predict arterial disease to a more conventional imaging method called angiography. In the other study, researchers used a PET stress test and measured CFR to determine whether age is always a risk factor for arterial disease.

"The quantification of CFR with molecular imaging provides a substantial advantage for unmasking coronary artery disease, even in patients who would otherwise be considered healthy with normal myocardial perfusion imaging," says Michael Fiechter, M.D., lead investigator of one study in cardiac imaging at the department of radiology for University Hospital Zurich, Zurich, Switzerland.

Measuring CFR goes beyond traditional myocardial perfusion imaging, which is based on visual interpretation of the differences between blood flow at rest and under stress, and instead actually quantifies coronary artery disease using imaging data acquired during scanning. The molecular imaging technique is made possible with PET, which uses injected imaging probes that emit signals picked up by a specialized scanner. Coronary artery disease is often evaluated using angiography, an X-ray procedure that involves catheterization and the injection of a dye into the coronary arteries in order to image blood flow and structure of the vessels, and echocardiography, which uses sound waves to image the heart.

"Although different studies revealed a prognostic value of CFR, this study is the first that systematically assessed the diagnostic value of CFR against invasive coronary angiography as a standard of reference for detection of coronary artery disease," says Philipp Kaufmann, M.D., a lead author of one of the studies in the department of radiology and cardiac imaging at University Hospital Zurich, Zurich, Switzerland.

In the two presented studies, a total of 777 elderly participants underwent myocardial perfusion imaging with PET and either Rb-82 or N-13-ammonia as an imaging biomarker to evaluate quantitative CFR as an indicator for coronary artery disease. One study of 73 participants concluded significant improvements across five different reference points including sensitivity, positive predictive value, and accuracy of myocardial perfusion imaging compared to imaging studies without CFR measurements.

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Molecular imaging 'sees' inside coronary arteries to measure disease

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Contact: Susan Martonik smartonik@snm.org 703-652-6773 Society of Nuclear Medicine

Miami Beach, Fla. (June 11, 2012)An arsenal of Alzheimer's research revealed at the Society of Nuclear Medicine's 59th Annual Meeting indicates that beta-amyloid plaque in the brain not only is involved in the pathology of Alzheimer's disease but may also precede even mild cognitive decline. These and other studies advance molecular imaging for the early detection of beta-amyloid, for which one product is now approved in the United States , as a major push forward in the race for better treatments.

"Diagnosis of Alzheimer's disease can now be made when the patient first presents symptoms and still has largely preserved mental function," says Christopher Rowe, M.D., a lead investigator for the Australian Imaging, Biomarkers and Lifestyle study of aging (AIBL) and professor of nuclear medicine at Austin Hospital in Melbourne, Australia. "Previously there was an average delay of three years between consulting a doctor over memory concerns and the diagnosis of Alzheimer's, as the diagnosis required the presence of dementia. When used as an adjunct to other diagnostic measures, molecular imaging can help lead to earlier diagnosis. This may give the patient several years to prepare for dementia while they still have control over their destiny."

According to the World Health Organization, Alzheimer's disease affects an estimated 18 million people worldwide, and incidence of the disease is expected to double by the year 2025 to 34 million. The National Institute on Aging estimates that as many as 50 percent of Americans aged 85 or older are affected.

Alzheimer's disease is a chronic and currently incurable neurodegenerative disease. Beta-amyloid burden can begin to build in the brain several years, if not more than a decade, before an individual shows any sign of dementia. Those who go on to develop Alzheimer's disease not only lose their ability to remember their loved ones but also have difficulty with essential bodily functions such as breathing and swallowing in the late stages of disease.

In one study, researchers used a molecular imaging technique called positron emission tomography (PET), which images physiological patterns in the body. PET was combined with an imaging agent called F-18 florbetaben, which binds to amyloid in the brain. This and other PET agents are drawn to targets in the body and emit a positron signal that is picked up by a scanner. Here molecular imaging was performed in conjunction with clinical and neuropsychological testing in order to better understand the long-term effects of beta amyloid plaques in the brains of older individuals with mild cognitive impairment. Those of the 45 subjects in the study who showed high levels of imaging agent binding during imaging and atrophy of the hippocampus, the memory center, had an 80 percent chance of developing Alzheimer's disease within two years, researchers said.

"Molecular imaging is proving to be an essential part of Alzheimer's disease detection," says Rowe. "This and other amyloid imaging techniques will have an increasing role in the earlier and more accurate diagnosis of neurodegenerative conditions such as Alzheimer's disease due to their ability to measure the actual underlying disease process."

Another AIBL study included 194 healthy participants, 92 people with mild cognitive impairment and 70 subjects with Alzheimer's disease, and used another imaging agent called C-11 PiB (Pittsburgh compound B) with PET to gauge amyloid burden in the brain. Researchers showed that, in this study group, widespread amyloid plaque build-up preceded cognitive impairment, and those with extensive amyloid burden were at higher risk of cognitive decline.

This and another study mark two of the first studies of their kind focusing on beta amyloid in healthy subjects. In the other study, 137 adults with normal cognitive function aged 30 to 89 years were imaged using PET with F-18 florbetapir, now FDA-approved for the detection of beta amyloid plaques, as well as functional magnetic resonance imaging in order to explore how amyloid build-up affects connections in specific areas of the brain involved in cognition, namely the default mode and salience networks, which are responsible for different states of wakeful rest and alertness. Those with increased amyloid burden in these neural networks were prone to impaired cognitive performance.

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Molecular imaging detects signs of Alzheimer's in healthy patients

Public release date: 8-Jun-2012 [ | E-mail | Share ]

Contact: Julie Armour julie.armour@ketchum.com 908-656-5887 Ketchum New York

Miami Beach, Fla., June 8, 2012: Piramal Imaging SA, a subsidiary of Piramal Healthcare Limited [NSE: PIRHEALTH, BSE: 500302], will present data on several compounds from its molecular imaging portfolio at the Society of Nuclear Medicine's 59th annual meeting in Miami Beach, Fla., from June 9 - 13. Data from five florbetaben studies will be featured, including results from a pivotal Phase III trial which will provide the basis for regulatory submission later this year.

Earlier this spring, Piramal Imaging was formed through the acquisition of worldwide rights to the molecular imaging research and development portfolio of Bayer Pharma AG. Florbetaben, a late-stage amyloid imaging agent being studied as a potential tool to aid in the diagnosis and assessment of Alzheimer's disease, is the lead compound in the portfolio.

Historically, the only way to definitively diagnose Alzheimer's disease has been after death at autopsy through analysis and identification of beta-amyloid in brain tissue. The global Phase III trial employed a unique and rigorous study design comparing in vivo brain positron emission tomography (PET) imaging with florbetaben to post-mortem analysis of the brain tissue. Another study compared florbetaben scans of people with mild cognitive impairment (MCI) over time to assess their risk of developing Alzheimer's disease.

"What better way to introduce Piramal Imaging to the nuclear medicine community," says Dr. Ludger M. Dinkelborg, CEO Piramal Imaging. "We believe we have the richest molecular imaging portfolio in the industry today, and the range of research we are presenting here reflects the depth, diversity and clinical relevance of our pipeline." Before co-founding Piramal Imaging, Dr. Dinkelborg served as Head of Diagnostic Imaging Research and Head of Molecular Imaging at Bayer Healthcare.

Piramal Imaging is developing an innovative and proprietary tracer portfolio to address major clinical needs in Alzheimer's disease, prostate cancer, lung cancer, liver cancer, and cardiovascular disease.

"Our goal is to be a leader in molecular imaging through increased diagnostic accuracy of serious medical conditions to improve patient care," says Dr. Swati A. Piramal, Director, Piramal Healthcare Limited. "On a parallel track with our aggressive clinical development program, we are taking the necessary steps toward bringing our tracers to market through the formation of strategic partnerships." Dr. Piramal was recently elected to the Harvard Board of Overseers and also serves on the Dean's Advisory Board of both the Harvard School of Public Health and Harvard Business School.

At this meeting, research on several of the company's pipeline compounds will be featured, including:

NOTE TO EDITORS: All data is embargoed until the date/time of presentation.

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Piramal Imaging to present data at Society for Nuclear Medicine Annual Meeting

DUBLIN--(BUSINESS WIRE)--

Dublin - Research and Markets (http://www.researchandmarkets.com/research/7m2ls7/european_molecular) has announced the addition of Frost & Sullivan's new report "European Molecular Diagnostics Markets" to their offering.

This Frost & Sullivan research service titled European Molecular Diagnostics Markets provides a comprehensive analysis of key challenges, drivers, and restraints as well as recent venue forecasts. It also examines major trends and initiatives in the molecular diagnostics market. The research covers oncology, genetic diseases, infectious diseases and pharmacogenomics segments.

Market Overview

Automation to Play Important Role in Expansion of Molecular Diagnostics Markets

The potential for enhanced clinical efficiency and reduced costs is fuelling the interest of healthcare stakeholders in personalised and preventive medicine. Molecular diagnostics is a vital tool to support this trend. Available molecular diagnostics technologies can detect diseases at very early stages and help monitor the efficacy of therapies being used in disease treatment. Technology advances, paralleled by the decreasing cost of automated systems, will boost market prospects, notes the analyst of this research. Automation, in particular, will play an increasingly important role in market expansion.

Many molecular diagnostic methods were historically based on steps of manual pipetting. Automated devices are nowadays replacing them and offer numerous advantages. These include faster turn-around time (TAT), manipulation of smaller volumes of liquids as well as more accurate and quantifiable results, compared to manual methods. Automation is currently of interest mostly among large diagnostic laboratories, but it is expected that, over time, automated systems will also be available at smaller laboratories, remarks the analyst. In small and medium-sized laboratories, if automation is implemented at all, it is likely to be based on single function automated devices rather than fully automated, comprehensive systems. However, automation of molecular diagnostics is still considered to be insufficient. This is especially the case in sample preparation and nucleic acid extraction, where the majority of work is performed manually. This leads to prolonged TAT, which is a challenge, especially when immediate results are required.

Market Sectors

Expert Frost & Sullivan analysts thoroughly examine the following market segments in this research:

- Oncology

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Research and Markets: European Molecular Diagnostics Markets

SALT LAKE CITY, June 6, 2012 /PRNewswire/ -- In May 2012, BC Technical, Inc. acquired Xpert, a Molecular Imaging service company focused on systems, parts and customized service solutions out of Redmond, WA. This acquisition will expand Utah-based BC Technical's customer base and service presence in the Northwest.

(Logo: http://photos.prnewswire.com/prnh/20120510/LA04560LOGO)

Former Xpert CEOs Nick Cecil and Dave Baxter have over 65 years of nuclear medicine imaging experience. Both worked for Siemens before starting Xpert 18 years ago. They brought that expertise to Xpert, primarily servicing Siemens products.

Baxter comments, "[Cecil and I] are excited to bring our experience in Siemens service and sales to strengthen BC Technical's Siemens position in the three-state area (Oregan, Idaho, and Washington). We are excited to join BC Technical, and are looking forward to the new chapter in our lives."

BC Technical's President and CEO Mark Alvarez comments, "As we focus on multi-hospital systems and integrated health networks, adding the Xpert team will complement our existing field service engineers in the three-state area, grow our expertise in Siemens nuclear medicine and PET, and will clearly add value. Xpert has an impeccable track record and reputation, and we are so pleased and excited for the Xpert team to join the BC Technical family. With the combination of the two teams, all customers in the three-state area now have a no-compromise option for all their molecular imaging needs."

BC Technical is headquartered in Salt Lake City, UT. Founded in 1995, BC Technical is the leading non-OEM Molecular Imaging Solution Provider of service, support, refurbished systems and parts for the Nuclear Medicine, PET, PET/CT, SPECT, and SPECT/CT market.

ABOUT BC TECHNICALBC Technical is in a category by itselfthey have the resources, quality and experience expected of the OEMs with the value, flexibility and responsiveness expected of a smaller independent company. BC Technical's ISO 13485 certification ensures quality and consistency with their refurbished systems, service and parts. Customer service and technical support are available 24 hours a day, seven days a week and 365 days a year. BC Technical was established in 1995, and has been backed by one of the country's premier private equity firms since 2009. BC Technical focuses on providing premium Molecular Imaging solutions. For more information or to learn more about BC Technical, please call 888-BCTECH1 (228.3241) or visit us online at http://www.bctechnical.com.

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BC Technical, Inc. Acquires Xpert

Public release date: 6-Jun-2012 [ | E-mail | Share ]

Contact: Garth Hogan ghogan@asmusa.org American Society for Microbiology

Washington, DCJune 6, 2012 Myron M. Levine, M.D., D.T.P.H. has been honored with the Maurice Hilleman/Merck Award, ASM's premier award for major contributions to pathogenesis, vaccine discovery, vaccine development, and control of vaccine-preventable diseases. "Levine pioneered molecular approaches to develop attenuated recombinant Salmonella Typhi and Shigella as live oral vaccines and as live vectors," described his nominator, Harriet Robinson of GeoVax, Inc. "For decades he has engaged in the gamut of vaccine research, including epidemiologic field studies that quantify disease burden, basic laboratory efforts to engineer candidate vaccines, early clinical trials to assess vaccine safety and immunogenicity, large-scale controlled field trials to assess vaccine efficacy, and measurement of public health impact following the introduction of vaccines."

Levine is currently Director of the Center for Vaccine Development (CVD), which he co-founded in 1974, of the University of Maryland School of Medicine. He is also Head of the Division of Geographic Medicine and Betsy & Simon Grollman Distinguished Professor, both in the Department of Medicine, and a Professor in the Departments of Pediatrics, Microbiology & Immunology, and Epidemiology & Public Health.

Levine received his M.D. from the Medical College of Virginia and his D.T.P.H. from the London School of Hygiene & Tropical Medicine, and is board certified in pediatrics and preventive medicine. His extensive time at the University of Maryland includes over twenty years (1984-2005) as Head of the Division of Infectious Diseases & Tropical Pediatrics.

Levine, an advocate for mucosal immunization, has made seminal contributions in basic vaccinology, bacterial pathogenesis, clinical research, field epidemiology and public health. His laboratory research has focused on construction and characterization of attenuated strains of Salmonella Typhi, S. Paratyphi A, non-typhoidal Salmonella serovars and Shigella to serve as live oral vaccines and as live vectors for the expression of foreign antigens. He has applied his extensive experience working on the epidemiology and prevention of infectious diseases in developing countries to his research on pathogenesis and the development and testing of vaccines. He has 42 years of involvement in the conduct of Phase 1, 2, 3 and 4 clinical trials to evaluate the safety, immunogenicity and efficacy of a wide array of vaccines and has pioneered clinical trials in developing countries, including vaccines developed at the CVD. He designed and supervised the performance of large-scale, randomized, controlled field trials investigating the efficacy of live oral typhoid vaccines (which led to licensure of Ty21a by the FDA). His post-licensure work with Haemophilus influenzae type b conjugate vaccine led to early introductions into the routine infant immunization schedule in Chile and Mali (West Africa).

In addition to his research accomplishments, "Levine is an outstanding colleague and leader," says Gary Nabel, Vaccine Research Center, NIAID. "His advice as an external scientific adviser has been invaluable to me personally as an external scientific adviser, and his recommendations have been critical in shaping the direction of our efforts at the Vaccine Research Center." Levine has a long track record in training individuals to pursue careers in basic, clinical and field vaccinology, and many have themselves since made major contributions to vaccinology.

Levine is a member on editorial boards of several journals and consults for many organizations including the World Health Organization, NIH, the Vaccine Research Center, Institute of Medicine, the U.S. Department of Defense, and multiple vaccine biotech companies and vaccine manufacturers. He was a member of the first Working Group of the Global Alliance for Vaccines and Immunization (GAVI Alliance) and was Co-Chair of the GAVI Task Force on Research and Development. He is a member of the Institute of Medicine of the National Academy of Sciences, the Association of American Physicians, the American Society of Clinical Investigation and the American Academy of Microbiology. He is past President of the American Epidemiological Society and the American Society of Tropical Medicine and Hygiene.

Levine's many honors include the Albert B. Sabin Gold Medal Award for lifetime achievement in vaccinology, selection by the editors of Baltimore Magazine as "Baltimorean of the Year," and award of the rank of "Grand Officer of the National Order of Mali" by the President of Mali for efforts in introducing new vaccines to the country's children. "More than any individual accomplishments, what stands out is the focus of Levine's work on the world's most vulnerable populations," Nabel further explains. "His efforts have focused on vaccine discovery for diseases that take their highest toll among children."

Among the 100 most cited researchers in immunology, Levine has 518 publications in refereed journals, 114 book chapters and is Senior Editor of the 4th edition of New Generation Vaccines, a textbook of research vaccinology. Rino Rappuoli, Novartis Vaccines and Diagnostics, describes Levine as "a giant in the field of vaccinology." He continues, "I cannot think of another person today that can match his lifetime contribution to vaccine discovery, vaccine development, and implementation of vaccination. He is not only a great scientist, but also a great entrepreneur of science that uses his science and passion to discover, develop, and make available to people new vaccines."

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The American Society for Microbiology honors Myron M. Levine

CHICAGO--(BUSINESS WIRE)--

bioTheranostics, developer of innovative oncology diagnostic tests and solution provider for metastatic cancer, today announced study results showing that tumor profiling with its CancerTYPE ID molecular test helped guide site-specific chemotherapy and improve overall survival for patients with carcinoma of unknown primary site (CUP). The results were presented at the 2012 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.

The prospective trial, led by John Hainsworth, M.D., and F. Anthony Greco, M.D., of the Sarah Cannon Research Institute, utilized the CancerTYPE ID molecular classifier on 252 previously untreated CUP patients. Of the 194 patients who received assay-directed first-line therapy, results showed that the median overall survival was 12.5 months versus 4.7 months for patients receiving empiric therapy (p=0.02).

This was the first prospective study in which molecular profiling was used to direct site-specific therapy in CUP patients, producing a median overall survival that compares favorably with previous trials of empiric CUP therapy, said bioTheranostics Chief Scientific Officer Mark Erlander, Ph.D. Importantly, evidence from this study supports the use of molecular tumor profiling in the standard management of patients with CUP.

Richard Ding, CEO of bioTheranostics, said this study demonstrates the diagnostic and therapeutic utility of CancerTYPE ID in CUP management. These results show the value of CancerTYPE ID in improving treatment efficacy by directing site-specific therapy, he said. The results strengthen the rationale for molecular profiling in CUP management and show the value of precision medicine.

Ding said the results of this study are supported by two other studies presented at ASCO. This includes the first study to compare molecular classification versus the standard-of-care immunohistochemistry (IHC), which showed that CancerTYPE ID has a higher level of diagnostic accuracy than IHC (Abstract #e21019) in a series of 122 difficult-to-diagnose cases. A second blinded, multi-institutional study with three centers of excellence (UCLA, Mayo Clinic, and Massachusetts General Hospital)the largest validation study of a molecular classifier to date (Abstract #10588)showed that CancerTYPE ID has a high level of accuracy in predicting main tumor type and subtype, as well as stable performance in primary versus metastatic tumors, and in samples where specimen quantity was limited, as is common with core and fine needle biopsies.

Taken together, these results support the use of the CancerTYPE ID assay as a standardized diagnostic aid when primary tumor site is uncertain, Ding said. They also serve to solidify bioTheranostics position as a partner and solution provider in metastatic cancer.

CancerTYPE ID is being exhibited at bioTheranostics booth, No. 16097. To view the abstract, click here.

About bioTheranostics

bioTheranostics is the leading solution provider for metastatic cancer management, leveraging its unique expertise in expression profiling to develop a growing array of molecular diagnostic tests for cancer patients. The company operates a CLIA-certified, CAP-accredited diagnostic laboratory to perform its proprietary tests: the CancerTYPE ID molecular classification test; PRCISSM Precision Medicine, which includes biomarker profiles for non-small cell lung and colorectal cancers; and Breast Cancer IndexSM, which quantifies risk of recurrence of estrogen receptor positive, lymph node negative breast cancer. bioTheranostics, a bioMrieux company, is based in San Diego. For more information, visit http://www.biotheranostics.com.

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Prospective Study Shows Favorable Overall Survival in Cancer of Unknown Primary Patients With Therapy Directed by ...

INDIANAPOLIS, June 5, 2012 /PRNewswire/ --Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the establishment of a strategic alliance with med fusion LLC in Lewisville, Texas, that designates the company as a Roche Molecular Center of Excellence (MCOE) for the next five years.

As a nationally recognized Roche MCOE, med fusion's molecular diagnostics laboratory will offer physicians and patients some of the latest and most advanced molecular technologies, such as Roche's cobas 4800 BRAF V600 Mutation Test, a companion diagnostic approved by the FDA in 2011 to identify patients who are eligible for treatment with the drug ZELBORAF (vemurafenib) for inoperable or metastatic melanoma, a deadly form of skin cancer.

Established in 2002, Roche's MCOE program is designed to create an alliance network that enables non-competing regional laboratories across the U.S. to collaborate and capitalize on scientific knowledge in molecular testing and, in turn, help accelerate the advancement of new test methods and technology.

"Roche is very pleased to welcome med fusion into the Molecular Center of Excellence alliance," said Whitney Green, senior vice president, molecular diagnostics at Roche Diagnostics Corporation. "We value their expertise and look forward to working together in implementing molecular technologies in the advancement of personalized medicine."

med fusion is one of 35 labs in the U.S. and three in Texas that have received this recognition and joined in this strategic partnership with Roche. "This relationship with Roche will help keep med fusion on the leading edge of technology and help ensure that we are supporting physicians and patients with the most advanced molecular technologies," said Dr. Thomas Lohmann, chief medical officer at med fusion. Keith Laughman, chief executive officer, added that the alliance "further supports med fusion's current and future collaborations as it continues to execute its targeted diagnostics initiatives."

About med fusion Headquartered in Lewisville, Texas, med fusion is an integrated, advanced laboratory and clinical trials service organization providing support to healthcare providers, biotech and pharmaceutical companies, through a patient-centric support model. Based in a 130,000- square foot facility, the company's clinical laboratory includes a dedicated test development and validation team to quickly meet the needs of clients. med fusion currently has over 300 well-trained employees, and a dedicated lab staff with an average of 16 years of experience.

About RocheHeadquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche's personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2011, Roche had over 80,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 42.5 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: http://www.roche.com or http://www.roche-diagnostics.us.

COBAS is a trademark of Roche. All trademarks mentioned in this release are protected by law.

For further information, please contact:

RocheJennifer Zinn Vice President, Communications Roche Diagnostics Corporation Indianapolis, Indiana USA (317) 521-4245 jennifer.zinn@roche.com

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Roche Diagnostics enters strategic alliance with med fusion that recognizes company as a Roche Molecular Center of ...

CHICAGO, June 2, 2012 /PRNewswire/ --

--TLE3 Biomarker Over-expressed in HER2-positive, Hormone Receptor-positive, and Triple-negative Breast Cancers --

-- EGFR status May Facilitate Therapeutic Decision-making in Head and Neck Cancer --

Caris Life Sciences announced today the utility of the company's Caris Target Now evidence-based molecular profiling service in the characterization of breast and head and neck cancers. These data were presented today at the 2012 annual meeting of the American Society of Clinical Oncology (ASCO).

"By combining state-of-the-art genomic sequencing technology with a rigorous review of the clinical literature, Caris Target Now provides tumor-specific biomarker information, enabling physicians to make more informed, individualized treatment decisions for their patients," said Sandeep Reddy, MD, clinical professor of medicine at the David Geffen School of Medicine at the University of California, Los Angeles (UCLA). Loapracticing oncologist and clinical advisor to Caris Life Sciences. "The data presented today have potentially important predictive implications for patients with breast and head and neck cancers, as the molecular profiling information may point the way toward personalizing therapy based on tumor genetics."

Breast Cancer Data

In a poster presentation today, Gargi Basu, Ph.D., and colleagues at Caris Life Sciences, presented results from the first study providing a comprehensive review of transducin-like enhancer of split 3 (TLE3) expression in breast cancer subtypes. They described TLE3 as a transcriptional repressor that influences tumor growth and microtubule stability; its expression in epithelial tumor cells may reflect that these cells require the expression of TL3 to maintain their undifferentiated state. The expression of TLE3 is also associated with response to taxane therapy in patients with breast cancer.

Working with tumor cells collected from 978 breast cancer patients, the investigators employed two different technological platforms used in Caris Target Now -immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) - to gather information on four biomarkers: TLE3 (M-201), ER(1D5), PR(PgR636), and human epidermal growth factor receptor 2 (HER2)/neu (Polyclonal). IHC analysis of the four biomarkers was conducted at the protein level, and FISH was used to determine amplification of HER2/neu. Samples were then sub-classified as hormone receptor (HR)-positive (i.e., estrogen receptor [ER]-positive and/or progesterone receptor [PR]- positive), HER2-positive (either at the protein level or amplified by FISH), or triple-negative (i.e., lacking in ER, PR, and HER2/neu).

Overall, 351 (36%) of the patients were HR-positive, 150 (15%) were HER2-positive, and 477 (49%) were triple-negative. TLE3 was expressed in 82% of the HR-positive patients, 73% of the HER2-positive patients, and 61% of the triple-negative patients. To further investigate TLE3 expression in the patient subtypes, Dr. Basu and colleagues performed a pairwise Fisher's Exact Test between the various pairs; this analysis revealed that for all pairs, the ratios of TLE3-expressing individuals were significantly different. The largest difference was observed between the HR-positives and the triple-negatives (82% vs. 61%, respectively; p=2.509e-10), suggesting that the HR-positives have a higher likelihood of responding to taxane therapy. The HER2-positives, at 73%, had a ratio that was significantly higher than the triple-negatives and significantly lower than the HR-positives.

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ASCO Presentations Highlight Clinical Utility of Caris Target Now™ in Molecular Profiling of Breast and Head and Neck ...

Public release date: 1-Jun-2012 [ | E-mail | Share ]

Contact: Christine Somosi christine.somosi@case.edu 216-368-6287 Case Western Reserve University

Cleveland -- A team of researchers led by Dr. Goutham Narla at Case Western Reserve University School of Medicine in collaboration with scientists at Mount Sinai School of Medicine in New York, have discovered a previously unrecognized signaling network disrupted in lung cancer that can be turned back on by a novel combination of two previously approved FDA drugs. The drug combination targets a pathway to treat advanced/late stage lung cancer. The work highlights how understanding the basic mechanisms regulating cancer development and progression can lead to new uses for existing FDA approved drugs in the treatment of cancer.

"Because of the financial constraints and length of time it takes to bring new drugs through clinical trials, scientists are moving toward using existing drugs in new ways so that the process of translating the discoveries of today into the treatments of tomorrow can be accelerated," said Goutham Narla, MD, PhD, assistant professor, Department of Medicine, Institute of Transformative Molecular Medicine, Case Western Reserve University School of Medicine. Dr. Narla is also a medical geneticist at University Hospitals Case Medical Center.

"This 'movement' in science toward using existing FDA approved drugs for new purposes in the treatment of cancer has expanded our understanding of the pathways that cause the disease and significantly accelerates our ability to treat a greater number of patients. In many instances, every month makes a difference for a patient when dealing with terminal cancer," said Dr. Narla.

Dr. Narla's laboratory focuses on the identification and characterization of the genes and pathways involved in cancer metastasis. By studying the functional role of the KLF6 tumor suppressor gene, Dr. Narla and his team have identified new signaling pathways regulated by this gene family thus providing new insight into cancer diagnosis and treatment. The team's research found that KLF6 and FOXO1, both tumor suppressor genes, are turned off as cancer spreads through the body. By using a combination of two existing FDA drugs - Erlotinib, a targeted cancer drug, and Trifluoperazine, a medication used to treat schizophrenia - the team developed an understanding of the properties that turn these critical genes back on, initiating tumor cells to die.

Since first discovering the KLF6 gene 13 years ago as a medical student at the Mount Sinai School of Medicine in the laboratory of Dr. Scott Friedman, Dr. Narla has been involved in the identification and characterization of the KLF6 gene and its role in cancer development and the progression of cancer.

###

This study appears online in the Journal of Clinical Investigation.

Additional support for Dr. Narla's research comes from the Case Comprehensive Cancer Center, Case Western Reserve University School of Medicine, Case Western Reserve University Institute for Transformative Molecular Medicine, and the Mount Sinai School of Medicine. Dr. Narla is also supported by an early physician scientist career award from the Howard Hughes Medical Institute (HHMI).

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Researchers discover new combination of 2 previously approved FDA drugs to treat lung cancer

Newswise Cleveland -- A team of researchers led by Dr. Goutham Narla at Case Western Reserve University School of Medicine in collaboration with scientists at Mount Sinai School of Medicine in New York, have discovered a previously unrecognized signaling network disrupted in lung cancer that can be turned back on by a novel combination of two previously approved FDA drugs. The drug combination targets a pathway to treat advanced/late stage lung cancer. The work highlights how understanding the basic mechanisms regulating cancer development and progression can lead to new uses for existing FDA approved drugs in the treatment of cancer.

Because of the financial constraints and length of time it takes to bring new drugs through clinical trials, scientists are moving toward using existing drugs in new ways so that the process of translating the discoveries of today into the treatments of tomorrow can be accelerated, said Goutham Narla, MD, PhD, assistant professor, Department of Medicine, Institute of Transformative Molecular Medicine, Case Western Reserve University School of Medicine. Dr. Narla is also a medical geneticist at University Hospitals Case Medical Center.

This movement in science toward using existing FDA approved drugs for new purposes in the treatment of cancer has expanded our understanding of the pathways that cause the disease and significantly accelerates our ability to treat a greater number of patients. In many instances, every month makes a difference for a patient when dealing with terminal cancer, said Dr. Narla.

Dr. Narlas laboratory focuses on the identification and characterization of the genes and pathways involved in cancer metastasis. By studying the functional role of the KLF6 tumor suppressor gene, Dr. Narla and his team have identified new signaling pathways regulated by this gene family thus providing new insight into cancer diagnosis and treatment. The teams research found that KLF6 and FOXO1, both tumor suppressor genes, are turned off as cancer spreads through the body. By using a combination of two existing FDA drugs - Erlotinib, a targeted cancer drug, and Trifluoperazine, a medication used to treat schizophrenia - the team developed an understanding of the properties that turn these critical genes back on, initiating tumor cells to die.

Since first discovering the KLF6 gene 13 years ago as a medical student at the Mount Sinai School of Medicine in the laboratory of Dr. Scott Friedman, Dr. Narla has been involved in the identification and characterization of the KLF6 gene and its role in cancer development and the progression of cancer.

This study appears online in the Journal of Clinical Investigation.

Additional support for Dr. Narlas research comes from the Case Comprehensive Cancer Center, Case Western Reserve University School of Medicine, Case Western Reserve University Institute for Transformative Molecular Medicine, and the Mount Sinai School of Medicine. Dr. Narla is also

supported by an early physician scientist career award from the Howard Hughes Medical Institute (HHMI).

Recently, Dr. Narla has also been named the first Harrington Distinguished Scholar. This inaugural award provides physician-scientists who have potential breakthroughs with the ability to tap into grant funding, as well as a peer network of innovators and mentors within the University Hospitals Harrington Discovery Institutes infrastructure to support their discovery efforts

Dr. Narla is the principal investigator leading a multidisciplinary team with investigators at both the Mount Sinai School of Medicine and the Case Western Reserve University School of Medicine that includes Jaya Sangodkar, Neil S. Dhawan, Heather Melville, Varan J. Singh, Eric Yuan, Huma Rana, Sudeh Izadmehr, Caroline Farrington, Sahar Mahzar, Suzanna Katz, Tara Albano, Pearlann Arnovitz, Rachael Okrent, Michael Ohlmeyer, David Burstein, David Zhang, Katerina Politi and Analisa DiFeo.

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Researchers Discover New Combination of Two Previously Approved FDA Drugs to Treat Lung Cancer

01.06.2012 - (idw) Ruprecht-Karls-Universitt Heidelberg

How do cells respond to damage and how are disturbances in cellular equilibrium avoided or compensated? These issues are at the heart of a new Collaborative Research Centre funded by the German Research Foundation (DFG) and ready to be launched at Heidelberg University on 1 July 2012. The CRC 1036 Cellular Quality Control and Damage Response is coordinated by Prof. Dr. Bernd Bukau, director of the Center for Molecular Biology of Heidelberg University (ZMBH). In the course of the next four years, this new research venture will receive funding to the tune of over ten million Euros. Press Release Heidelberg, 1 June 2012

New Collaborative Research Centre in Molecular Biology DFG provides over ten million Euros to fund CRC Cellular Quality Control and Damage Response

How do cells respond to damage and how are disturbances in cellular equilibrium avoided or compensated? These issues are at the heart of a new Collaborative Research Centre funded by the German Research Foundation (DFG) and ready to be launched at Heidelberg University on 1 July 2012. The CRC 1036 Cellular Quality Control and Damage Response is coordinated by Prof. Dr. Bernd Bukau, director of the Center for Molecular Biology of Heidelberg University (ZMBH). In the course of the next four years, this new research venture will receive funding to the tune of over ten million Euros.

The 17 research projects constituting CRC 1036 focus on the molecular mechanisms of cellular quality control. Despite their complexity, biological processes normally function with incredible precision, says Prof. Bukau. Nevertheless, the underlying processes are subject to occasional errors aggravated by external chemical or physical stress factors. In response to these mishaps, the cells of all organisms have developed efficient networks of surveillance systems operating at the levels of macromolecules, cellular compartments, cells and organs. These networks minimise and reverse damage caused by process deficiencies and defective molecules, Prof. Bukau adds.

At present, Heidelberg University receives funding for eight Collaborative Research Centres. In addition, there are five CRC/Transregio with key Heidelberg participation, four of them with coordinators from the university. Alongside CRC 1036, the German Research Foundation has also approved the establishment of CRC/TRR 125 Cognition-Guided Surgery starting up on 1 July 2012. Coordinator is the Heidelberg medical scientist Prof. Dr. Markus W. Bchler.

Contact Prof. Dr. Bernd Bukau Center for Molecular Biology of Heidelberg University (ZMBH) Phone: +49 6221 54-6850 direktor@zmbh.uni-heidelberg.de

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New Collaborative Research Centre in Molecular Biology

ScienceDaily (May 31, 2012) The 20 proteins in the Wnt family are some of the most important proteins in controlling how an organism develops and grows, but for 30 years scientists have not known what these vital proteins actually look like. The proteins have eluded standard visualization techniques, in large part because they do not dissolve well in the water-based liquids normally used for biochemical studies. But once Howard Hughes Medical Institute investigator K. Christopher Garcia, and Claudia Janda, a post-doctoral fellow in his Stanford University School of Medicine lab, thought of an approach to make the proteins behave better, they succeeded in solving the first structure of a Wnt protein.

Their work, published online May 31, 2012, in Science Express, reveals an unexpected three-dimensional shape that offers clues to how Wnt proteins function and clarifies the nature of its Frizzled receptor target for drug developers working to design anti-Wnt therapies for cancer and other diseases. "Having finally gained structural access to Wnts, I think this is going to open up a whole new era in molecularly dissecting the role of Wnt proteins in biological processes," says Garcia.

Wnt proteins were discovered 30 years ago by Harold Varmus, the current director of the National Cancer Institute, and Roel Nusse, who is now an HHMI investigator at Stanford University. They observed that Wnt1, the gene for a Wnt protein, was very active in breast cancer cells from mice. Over the past decades, researchers have shown that Wnt proteins play key roles in embryonic development, tissue regeneration, bone growth, stem cell differentiation, as well as many human cancers. In essence, Wnt proteins help give cells their identity and tell them how to behave.

"This is one of the most important ligand-receptor systems in both human and invertebrate biology. Wnts cut across every field, which is why I got involved. But many excellent groups have tried to express them in the lab and solve their structures, so we realized that something non-intuitive would be required to crack the problem," says Garcia.

In 2003, Nusse's team found out why scientists who had been trying to isolate Wnt proteins had been plagued with so many difficulties: the proteins contained lipids, fatty molecules that prevent the protein from dissolving in water-based solutions. Scientists realized they could stabilize the protein by instead keeping it in mixtures that contained detergents, helping pave the way for a plethora of biochemical experiments on isolated Wnts. But such detergent-containing mixtures still present obstacles for crystallizing and visualizing proteins by structural analysis techniques; simply put, the detergents get in the way.

"This really causes a great deal of difficulty in working with these proteins," says Garcia. But he and Janda had an idea: what if they expressed both a Wnt protein, and the receptor it bound to in the same cell? Perhaps, they thought, the receptor would shield the Wnt protein's exposed lipid, making it able to dissolve in the solution they needed.

The technique worked -- they were able to produce Wnt8 bound to Frizzled-8, one of 10 Frizzled receptors that the 20 Wnt proteins bind to to carry out cellular effects.

"It's one of the most unusual protein structures I've ever seen," says Garcia. "It looks like a crab with its two pinchers reaching around and grabbing the Frizzled receptor. When we originally solved this, we could see no relationship between the structure of Wnt8 and any other structure that has ever been described. However, we are beginning to see the evolutionary origins of the Wnt fold. This story is developing."

Garcia expects the other Wnt proteins likely have similar structures, with the respective Frizzled receptors shielding the lipid attached to the protein, meaning their method should work on other Wnts. He now wants to delve into those structures, answering questions about which Wnt-Frizzled pairs are responsible for what biological roles, how co-receptors bind to the pairs, and how the structure can be changed to optimize the interactions.

"What we can see now are some clues in the structure as to why Wnts are so hard to express, because of the exposure of the lipid," says Garcia. "So now we can think about ways to remodel the protein that will solve the expression problem without altering function."

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New molecular structure offers first picture of a protein family vital to human health

IRVINE, Calif. and AMSTERDAM, May 31, 2012 /PRNewswire/ --Agendia, an innovative molecular cancer diagnostics company and leader in personalized medicine, today announced that the company has raised USD $65 million in a private round of equity financing.

"The support we have received in this round of financing is a strong reflection of our recent growth and confidence in the commercialization of our product pipeline in the future," said David Macdonald, CEO of Agendia. "We will use these funds to expand commercialization of our current breast cancer Symphony suite of tests, as well as for development of our personalized medicine pipeline. We have recently launched our Symphony suite in an FFPE format, and we are preparing to launch our ColoPrint recurrence test for stage II colon cancer prognosis and prediction."

The financing round was led by the Debiopharm Group (Debiopharm), a leading drug development company based in Switzerland, with significant support from all of Agendia's current investors, including; The Van Herk Group, ING Corporate Investments, Breedinvest and Gilde Healthcare. Agendia also brought in other new investors for the financing round, including Korys, the investment structure of the Colruyt family and others.

"Debiopharm has been very impressed by the quality of the work and recent substantial progress made by Agendia to overcome the hurdles it faced in the past. Agendia pioneered and advocated the implementation of personalized cancer management strategies. Its offering (both commercially and scientifically) has advanced molecular cancer diagnosis in its growing role. Becoming successful in this still challenging area will lead to substantial improvements for the selection of cancer therapies and, therefore, also enhance the cost-effectiveness of highly innovative and valuable treatments for subsets of patients. In other words, to us, Agendia will support genuine win-win strategies and facilitate the reduction of the gap between the diagnostic and the drug world," said Thierry Mauvernay, Delegate of the Board of Debiopharm.

"We are absolutely delighted to bring Agendia into our investment portfolio," stated Vincent Vliebergh, CEO of Korys. "The company's molecular diagnostic tests for breast cancer, developed and validated in close collaboration with leading academic centers,enable physicians to determine the most effective treatment for each individual patient, leading to better health outcomes and lower costs. As such, we see Agendia as a catalyst in the shift to more personalized medicine, and we look forward to working with the company to make this vision come true."

About Agendia:

Agendia is a leading molecular diagnostic company that develops and markets genomic-based diagnostic products, which help support physicians with their complex treatment decisions. Agendia's breast cancer Symphony suite was developed using unbiased gene selection, analyzing the complete human genome, ensuring 100% definitive results for cancer patients. Symphony includes MammaPrint, the first and only FDA-cleared IVDMIA breast cancer recurrence assay, as well as BluePrint, a molecular subtyping assay, TargetPrint, an ER/PR/HER2 expression assay, and TheraPrint, an alternative therapy selection assay. Together, these tests help physicians determine a patient's individual risk for metastasis, which patients will benefit from chemo, hormonal, or combination therapy, and which patients do not require these treatments and can instead be treated with other less arduous and less costly methods.

In addition to the Symphony suite of tests, Agendia has a rich pipeline of genomic products in development. The company collaborates with pharmaceutical companies, leading cancer centers and academic groups to develop companion diagnostic tests in the area of oncology and is a critical partner in the ISPY-2 and MINDACT trials.

For more information, please visit http://www.agendia.com.

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Agendia Raises $65 Million in a Private Round of Equity Financing