Public release date: 17-May-2012 [ | E-mail | Share ]

Contact: Raymond MacDougall macdougallr@mail.nih.gov 301-402-0911 NIH/National Human Genome Research Institute

People have increasing opportunities to participate in genetic testing that can indicate their range of risk for developing a disease. Receiving these results does not appreciably drive up or diminish test recipients' demand for potentially costly follow-up health services, according to a study performed by researchers at the National Institutes of Health and colleagues at other institutions.

The study in the May 17, 2012 early online issue of Genetics in Medicine was done by investigators with the Multiplex Initiative, a multi-center collaborative initiative involving investigators from the National Institutes of Health's Intramural Research Program, Group Health Cooperative in Seattle, and the Henry Ford Health System in Detroit.

The tests are available from a growing number of commercial producers, and health care providers have been uncertain whether people who received information only about risk would follow up by demanding diagnostic testing to monitor for predicted illnesses.

The study is the first to use electronic health records -- rather than self-reported behavior -- to measure the impact of genetic testing on the subsequent consumption of health services by commercially insured, healthy adults. Self reports, which can be affected by memory lapses and other problems, tend to be less accurate.

"We need to understand the impact of genomic discoveries on the health care system if these powerful technologies are going to improve human health," said Dan Kastner, M.D., Ph.D., scientific director and head of the National Human Genome Research Institute's (NHGRI) Division of Intramural Research. "We are still learning how to integrate new genomic discoveries into clinical care effectively and efficiently."

"There are a lot of unanswered questions about how genetic test results can be used to guide people towards making positive lifestyle and health behavior changes," said Colleen McBride, Ph.D., chief of NHGRI's Social and Behavioral Research Branch. "This study goes a long way towards bringing data to these debates and shows that people are not likely to make inappropriate demands of health delivery systems if they are properly informed about the limitations of genetic tests."

Genetic tests, such as those used in this study, can detect common variants of genes associated with modest alterations in the chances of developing particular diseases. The term multiplex refers to simultaneously performing multiple genetic tests on a single blood sample.

The study included 217 healthy people between the ages of 25 and 40 who elected to participate in genetic susceptibility testing offered by their health plan. The researchers analyzed health care usage by the participants in the 12 months before genetic testing and the 12 months following the testing. They also compared the test group's behavior with a group of about 400 similar plan members who declined the testing offer.

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NIH-led study finds genetic test results do not trigger increased use of health services

Recommendation and review posted by Bethany Smith

Medical experts feared personal genetic test results might drive overuse of expensive medical care

The study in the May 17, 2012 early online issue of Genetics in Medicine was done by investigators with the Multiplex Initiative, a multi-center collaborative initiative involving investigators from the National Institutes of Health's Intramural Research Program, Group Health Cooperative in Seattle, and the Henry Ford Health System in Detroit.

The tests are available from a growing number of commercial producers, and health care providers have been uncertain whether people who received information only about risk would follow up by demanding diagnostic testing to monitor for predicted illnesses.

The study is the first to use electronic health records -- rather than self-reported behavior -- to measure the impact of genetic testing on the subsequent consumption of health services by commercially insured, healthy adults. Self reports, which can be affected by memory lapses and other problems, tend to be less accurate.

"We need to understand the impact of genomic discoveries on the health care system if these powerful technologies are going to improve human health," said Dan Kastner, M.D., Ph.D., scientific director and head of the National Human Genome Research Institute's (NHGRI) Division of Intramural Research. "We are still learning how to integrate new genomic discoveries into clinical care effectively and efficiently."

"There are a lot of unanswered questions about how genetic test results can be used to guide people towards making positive lifestyle and health behavior changes," said Colleen McBride, Ph.D., chief of NHGRI's Social and Behavioral Research Branch. "This study goes a long way towards bringing data to these debates and shows that people are not likely to make inappropriate demands of health delivery systems if they are properly informed about the limitations of genetic tests."

Genetic tests, such as those used in this study, can detect common variants of genes associated with modest alterations in the chances of developing particular diseases. The term multiplex refers to simultaneously performing multiple genetic tests on a single blood sample.

The study included 217 healthy people between the ages of 25 and 40 who elected to participate in genetic susceptibility testing offered by their health plan. The researchers analyzed health care usage by the participants in the 12 months before genetic testing and the 12 months following the testing. They also compared the test group's behavior with a group of about 400 similar plan members who declined the testing offer.

The researchers counted the number of physician visits and laboratory tests or procedures the people received, particularly those services associated with four of the eight conditions tested by the multiplex panel. Most of the procedures or screening tests that were counted are not among those currently recommended for people in this age group who don't have symptoms. The researchers found that participants in genetic testing did not change their overall use of health care services compared with those not tested.

All of the individuals who elected to undergo the multiplex test carried at least one at-risk genetic marker, with the majority carrying an average of nine at-risk variants. The tests performed for the Multiplex Initiative include a set of genetic variants reliably associated with an increase in disease risk and for which some corrective health behavior has been shown to prevent illness.

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Genetic Test Does Not Trigger Increased Use of Health Services

Recommendation and review posted by Bethany Smith

May 18, 2012

Connie K. Ho for RedOrbit.com

Recently, genetic tests have been on the rise and are offered by more and more commercial producers. While there are many opportunities for people to participate in genetic testing, this doesnt necessarily mean that people are following up on those services. These are the results found in a study that is published in the May 17 issue of Genetics in Medicine.

The study was a collaborative project by the Multiplex Initiative, which includes researchers from the National Institutes of Healths Intramural Research Program, the Group Health Cooperative, and the Henry Ford Health System. Researchers analyzed variants of genes related to diseases such as colorectal cancer, coronary heart disease, high blood cholesterol, hypertension, lung cancer, melanoma, osteoporosis, and type 2 diabetes. The study allowed researchers to better understand patients health care needs.

Our study was a best-case scenario, because we chose 15 genes reliably associated with relatively small risks for eight common diseases that health behaviors can affect, remarked lead author Dr. Robert J. Reid in a prepared statement. We hope that testing positive activates patients to make behavior changes that could lower their risk, such as quitting smoking without causing them to make many extra visits to their doctors.

The report was one of the first studies that looked at electronic health records, as opposed to self-reported behavior, to quantify the impact of genetic testing on health services chosen by adults.

We need to understand the impact of genomic discoveries on the health care system if these powerful technologies are going to improve human health, explained Dr. Dan Kastner, scientific director and head of the National Human Genome Research Institutes (NHGRI) Division of Intramural Research, in a statement. We are still learning how to integrate new genomic discoveries into clinical care effectively and efficiently.

Genetic tests are also important because they can find variants of genes related to the changes in the risk of developing a particular disease.

Understanding personalized genetic information is important because it is becoming more readily available and we need to figure out how to integrate it effectively and efficiently into the clinical care we provide, noted coauthor Dr. Eric B. Larson in a prepared statement.

The scientists hope to continue to research consumer interest of genetic testing and how that affects patients long-term health care goals.

The rest is here:
Few Use Follow Up Services After Genetic Testing

Recommendation and review posted by Bethany Smith

Public release date: 17-May-2012 [ | E-mail | Share ]

Contact: Rebecca Hughes hughes.r@ghc.org 206-287-2055 Group Health Research Institute

SEATTLEPeople have more and more chances to participate in genetic testing that can indicate their range of risk for developing a disease. Receiving these results does not appreciably drive up or diminishtest recipients' demand for potentially costly follow-up health services, according to a new study in the May 17, 2012 early online issue of Genetics in Medicine.

The study was done by researchers with the Multiplex Initiative, a multi-center collaborative initiative involving investigators from the National Institutes of Health's Intramural Research Program, Group Health Cooperative in Seattle, and the Henry Ford Health System in Detroit.

The tests are available from a growing number of commercial producers, and health care providers have been uncertain whether people who received information only about risk would follow up by demanding diagnostic testing to check for predicted illnesses.

The study is the first to use electronic health recordsrather than self-reported behaviorto measure the impact of genetic testing on the subsequent use of health services by commercially insured, healthy adults. Self-reports, which can be affected by memory lapses and other problems, tend to be less accurate.

"Our study was a best-case scenario, because we chose 15 genes reliably associated with relatively small risks for eight common diseases that health behaviors can affect," said the study's first author Robert J. Reid, MD, PhD. Dr. Reid is Group Health's associate medical director of research translation and an associate investigator at Group Health Research Institute. Those diseases were type 2 diabetes, coronary heart disease, high blood cholesterol, hypertension, osteoporosis, lung cancer, colorectal cancer, and melanoma. "We hope that testing positive activates patients to make behavior changes that could lower their risk, such as quitting smoking," he added, "without causing them to make many extra visits to their doctors."

"Understanding personalized genetic information is important because it is becoming more readily available and we need to figure out how to integrate it effectively and efficiently into the clinical care we provide," said coauthor Eric B. Larson, MD, MPH, Group Health Cooperative's vice president for research and Group Health Research Institute's executive director.

"There are a lot of unanswered questions about how genetic test results can be used to guide people toward making positive lifestyle and health behavior changes," said Colleen McBride, PhD, chief of the Social and Behavioral Research Branch at the National Human Genome Research Institute (NHGRI). "This study goes a long way toward bringing data to these debates and shows that people are not likely to make inappropriate demands of health delivery systems if they are properly informed about the limitations of genetic tests."

Genetic tests, such as those used in this study, can detect common variants of genes associated with modest changes in the chances of developing particular diseases. "Multiplex" means simultaneously performing many genetic tests on one blood sample.

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Genetic testing may not trigger more use of health services

Recommendation and review posted by Bethany Smith

MONT-SAINT-GUIBERT, Belgium, May 18, 2012 /PRNewswire/ --

The Belgian biotechnology company, Cardio3 BioSciences (C3BS), a leader in the discovery and development of regenerative and protective therapies for the treatment of cardiovascular diseases, today announces that the final results of its Phase II clinical trial of C3BS-CQR-1 is will be presented at the late breaking clinical trial session at the European Society of Cardiology 2012 Heart Failure Congress in Belgrade, Serbia taking place on May 19-22.

Andr Terzic, M.D., Ph.D, Director at Center of Regenerative Medicine, Mayo Clinic, the co-lead investigator on the trial, will present new final follow up data on the Company's stem cell therapy for heart failure, C3BS-CQR-1, which is based on "Cardiopoiesis" proprietary technology. The presentation will be held on Sunday, May 20th in Belgrade, Serbia.

Dr. Christian Homsy, CEO of Cardio3 BioSciences, said: "Being selected to present the final follow-up data in the late breaking clinical trial session at this prestigious cardiology congress highlights the quality of our technology and reiterates our belief in C3BS-CQR-1 as a potential treatment for patients with heart failure, a condition with a significant unmet medical need. We look forward to advancing the product into Phase III."

About Cardio3 BioSciences

Cardio3 BioSciences is a Belgian leading biotechnology company focused on the discovery and development of regenerative and protective therapies for the treatment of cardiac diseases. The company was founded in 2007 and is based in the Walloon region of Belgium. Cardio3 BioSciences leverages research collaborations in the US and in Europe with Mayo Clinic and the Cardiovascular Center Aalst, Belgium.

The Company's lead product candidate C3BS-CQR-1 is an innovative pharmaceutical product consisting of autologous cardiac progenitor stem cells. C3BS-CQR-1 is based on ground breaking research conducted at Mayo Clinic that allowed discovery of cardiopoiesis, a process to mimic in adult stem cells the natural signals triggered in the early stages of life during the cardiac tissue development. Cardio3 BioSciences has also developed C-Cath, the next-generation injection catheter with superior efficiency of delivery of bio therapeutic agents into the myocardium.

C3BS-CQR-1, C-Cure, C-Cath, Cardio3 BioSciences and the Cardio3 BioSciences and C-Cath logos are trademarks or registered trademarks of Cardio3 BioSciences SA, in Belgium, other countries, or both. Mayo Clinic holds equity in Cardio3 BioSciences as a result of intellectual property licensed to the company. In addition to historical facts or statements of current condition, this press release contains forward-looking statements, which reflect our current expectations and projections about future events, and involve certain known and unknown risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. These forward-looking statements are further qualified by important factors, which could cause actual results to differ materially from those in the forward-looking statements, including timely submission and approval of anticipated regulatory filings; the successful initiation and completion of required Phase III studies; additional clinical results validating the use of adult autologous stem cells to treat heart failure; satisfaction of regulatory and other requirements; and actions of regulatory bodies and other governmental authorities. As a result, of these factors investors and prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or review any forward-looking statement, whether as a result of new information, future events or otherwise.

For more information contact:

Cardio3 BioSciences: http://www.c3bs.com Dr Christian Homsy, CEOTel : +32-10-39-41-00 Anne Portzenheim, Communication Manager aportzenheim@c3bs.com

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Cardio3 BioSciences Has Been Selected to Present C3BS-CQR-1 Trial Data in Late Breaking Clinical Trial Session at ...

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(Phys.org) -- By investigating the existence of an unusual four-stranded structure of DNA in human cells, scientists have opened the door to novel cancer therapeutics and a new era for personalised medicine.

When Watson and Crick discovered the double helix structure of DNA in 1953, they declared they had found the secret of life. However, as in all pursuits of science, the story did not end there. Less than 60 years later, a team led by chemist Professor Shankar Balasubramanian and cancer biologist Professor Steve Jackson has found that an unusual four-stranded configuration of DNA also forms at sites across the human genome in living cells.

Although known about by scientists for decades, the structure was considered to be something of a structural curiosity rather than a feature found in nature. It forms in regions of DNA that are rich in one of its building blocks, guanine (G), when a single strand of the double-stranded DNA loops out and doubles back on itself, forming a four-stranded handle in the genome.

G-quadruplexes have been known to occur at the ends of chromosomes in the regions known as telomeres, but it wasnt until a strong association had been noticed with genes responsible for cell proliferation that Balasubramanian and others began to suspect that G-quadruplexes might be a potential target for cancer therapy. If you synthesize a quadruplex-binding molecule and put it into cancer cells, it can impair the growth of these cells, he said. Weve come such a long way from thinking that we understand the genome and it appeared that this structure could tell us something new.

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Protecting the genetic code

At the heart of the new discovery is an innovative way of locating the structures in living cells and then capturing them for further examination. The scientists discovered that when pyridostatin binds to G-quadruplex DNA it causes a double-strand break in the double helix when the cell tries to replicate and copy its genes: Pyridostatin binding to G-quadruplexes is a major impediment to copying the genome so if a cell tries to replicate, this will generate breaks in the DNA, said Jackson.

Over the years, Jacksons lab has found that there are certain proteins in the cell that act as molecular policemen, patrolling the nucleus of the cell looking for damaged DNA. If they detect damage, they start making repairs, and at the same time set off alarm signals to alert the rest of the cell that theres a problem.

When there is no DNA damage, these molecular policemen are distributed evenly throughout each cells nucleus. But when cells are treated with pyridostatin, they congregate in specific locations on the DNA, indicating regions of damage, and showing up as dots under the microscope. The field really jumped on the idea that these dots represent telomeres that have G-rich sequences and in vitro have the potential to form G-quadruplexes, said Jackson. But we stained the dots for telomere proteins and found there was only a small amount of overlap. So clearly, this pyridostatin compound is inducing DNA damage in lots of other places, and we were faced with the issue: if they are not telomeres, what are they?

This confirmed an earlier finding in Balasubramanians lab by Julian Huppert, then a PhD student, who devised a computational search algorithm to map out every spot in the entire human genome that had potential to fold into a G-quadruplex. He found there were close to 350,000 of them.

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A new dimension to DNA and personalized medicine of the future

Recommendation and review posted by sam

NEW YORK & PARIS--(BUSINESS WIRE)--

Bionest Partners, a premier strategy and management consulting firm for the life science industries, and a recognized leader in personalized medicine (PM) strategy consulting, announces the publication of an article in a recent issue of Nature Reviews Drug Discovery (NRDD).

This article, a result of the FDA Personalized Medicine Initiative a consortium effort across the FDA, industry and academia analyzes the key value drivers of PM development and commercialization strategies, elucidates a comprehensive approach for evaluating these strategies, and employs various modeling tools to support decision-making.

The publication of this article is timely, given the significant and increasing commitment to PM by pharmaceutical companies, highlighted by recent PM launches such as Xalkori and Zelboraf, and notable PM candidates in the pipeline including T-DM1 (Roche/Genentech, for Her2 positive breast cancer), Dabrafenib (GSK, for BRAF V600E positive melanoma), and Afatinib (BI, for EGFR mutation positive NSCLC).

Dr. Sean X. Hu, Head of Bionest USA and Managing Partner, North America, a co-lead author of the article, and the only representative from the management consulting industry serving in the FDA PM Initiative consortium, points out that the key to successful decision-making around whether and how best to incorporate biomarkers into drug development and commercialization depends on an in-depth understanding of multiple disciplines: the underlying science, clinical trial design and development paths, regulatory requirements, partnership and coordination between drug and diagnostic partners, drug and diagnostic commercialization, pricing and market access, and decision-making in the context of many uncertainties. This article identifies key value drivers and risk factors associated with PM drug and diagnostic development and commercialization. In addition, it presents a coherent approach to tie these factors together, and describes the use of financial modeling tools to arrive at such metrics as risk-adjusted net present value (NPV) and return on investment (ROI) metrics that companies often use to make key investment decisions for their products.

Dr. Federico Goodsaid, who co-authored the article while at the FDA and is currently VP of Strategic Regulatory Intelligence at Vertex Pharmaceuticals, adds: This consortium, with the participation of FDA, academic institutions and many pharmaceutical companies, was a unique opportunity to advance the field of PM by tackling one of the bottlenecks in optimizing decision-making on PM development and commercialization strategies how to quantify the commercial value of a potential biomarker-based strategy. Sean and his team made this work possible with their knowledge about PM, advanced modeling tools, and rigor in the application of decision-analysis methods to assess the value of PM strategic options and to account for their corresponding risks and uncertainties.

Bionest is attending the upcoming ASCO 2012 Annual Meeting in Chicago, June 1 5, 2012. For further discussions with Dr. Hu and his Bionest team on PM strategies, either at ASCO 2012 or another occasion, please contact Dr. Rachel Laing (rlaing@bionest.com).

Bionest is a powerhouse in PM strategy consulting, experienced in a broad spectrum of project types, from corporate level PM business models, commercialization capability building, R&D and commercialization business processes, and organizational structure, to development and commercialization strategies for individual drug assets and companion diagnostics.

In addition, Bionest has been driving thought leadership on PM, with many articles published or in development on the strategic, commercial and technical aspects of PM, including a recent article in collaboration with the Personalized Medicine Coalition (PMC) in the December 2011 supplement issue of Science which describes the approaches for optimization of PM decision-making.

For more details, please visit http://www.bionest.com, and navigate to section Strategic/Practices/Personalized Medicine Strategy.

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Bionest Publishes Landmark Article on Quantitative Financial Analysis of Personalized Medicine Strategies

Recommendation and review posted by sam

NEWARK, Calif., May 17, 2012 (GLOBE NEWSWIRE) -- StemCells, Inc. (Nasdaq:STEM - News) today announced completion of the first planned interim safety review of the Company's Phase I/II spinal cord injury clinical trial, which indicated that the surgery, immunosuppression and the cell transplants have been well-tolerated. The trial, which is designed to evaluate the safety and preliminary efficacy of the Company's proprietary HuCNS-SC(R) cells (purified human neural stem cells), represents the first time that neural stem cells have been transplanted as a potential therapeutic agent for spinal cord injury. A summary of the data will be presented by Armin Curt, M.D., principal investigator for the clinical trial, at the Interdependence 2012 Global SCI Conference, which is being held in Vancouver, British Columbia, from May 15 to 17, 2012.

The interim data is from the first cohort of patients, all of whom suffered a complete spinal cord injury in which there is no neurological function below the level of the injury. All patients enrolled were transplanted with a dose of 20 million cells at the site of injury in the thoracic spinal cord. There were no abnormal clinical, electrophysiological or radiological responses to the cells, and all the patients were neurologically stable through the first four months following transplantation of the cells. Changes in sensitivity to touch were observed in two of the patients. The data from multiple evaluations of the patients during this four month period have been reviewed by an independent Data Safety Monitoring Committee, which has recommended that the study advance to enrollment of patients with incomplete neurological injury. Enrollment is now underway and is open to patients in Europe, the United States and Canada with incomplete spinal cord injury. The trial, which is being conducted at Balgrist University Hospital, Zurich, Switzerland, is the only ongoing clinical trial evaluating neural stem cell transplantation in spinal cord injury.

"We are very encouraged by the interim safety outcomes for the first cohort," said Dr. Curt, who is Professor and Chairman of the Spinal Cord Injury Center at the University of Zurich, and Medical Director of the Paraplegic Center at Balgrist University Hospital. "The patients in the trial are being closely monitored and undergo frequent clinical examinations, radiological assessments by MRI and sophisticated electrophysiology testing of spinal cord function. The comprehensive battery of tests provides important safety data and is very reassuring as we progress to the next stage of the trial."

The Interdependence 2012 Global SCI Conference is intended to bring together international healthcare and research facilities to showcase their work through presentations, workshops and exhibits and to discuss how to advance research, implement new best practices and shape the next generation of spinal cord injury research. Interdependence 2012 is jointly organized by the Rick Hansen Institute, a Canadian not-for-profit organization committed to accelerating the translation of discoveries and best practices into improved treatments for people with spinal cord injuries, and the Rick Hansen Foundation.

About the Spinal Cord Injury Clinical Trial

The Phase I/II clinical trial of StemCells, Inc.'s HuCNS-SC(R) purified human adult neural stem cells is designed to assess both safety and preliminary efficacy. Twelve patients with thoracic (chest-level) neurological injuries at the T2-T11 level are planned for enrollment. The Company has dosed the first three patients all of whom have injuries classified as AIS A, in which there is no neurological function below the injury level. The second and third cohorts will be patients classified as AIS B and AIS C, those with less severe injury, in which there is some preservation of sensory or motor function. The injuries are classified according to the American Spinal Injury Association Impairment Scale (AIS). In addition to assessing safety, the trial will assess preliminary efficacy based on defined clinical endpoints, such as changes in sensation, motor and bowel/bladder function.

All patients will receive HuCNS-SC cells through direct transplantation into the spinal cord and will be temporarily immunosuppressed. Patients will be evaluated regularly in the post-transplant period in order to monitor and assess the safety of the HuCNS-SC cells, the surgery and the immunosuppression, as well as to measure any recovery of neurological function below the injury site. The Company intends to follow the effects of this therapy long-term, and a separate four-year observational study will be initiated at the conclusion of this trial.

The trial is being conducted at Balgrist University Hospital, University of Zurich, a world leading medical center for spinal cord injury and rehabilitation, and is open for enrollment to patients in Europe, Canada and the United States. If you believe you may qualify and are interested in participating in the study, please contact the study nurse either by phone at +41 44 386 39 01 or by email at stemcells.pz@balgrist.ch.

Additional information about the Company's spinal cord injury program can be found on the StemCells, Inc. website at http://www.stemcellsinc.com/Therapeutic-Programs/Clinical-Trials.htm and at http://www.stemcellsinc.com/Therapeutic-Programs/Spinal-Cord-Injury.htm, including video interviews with Company executives and independent collaborators.

About Balgrist University Hospital

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StemCells, Inc. Reports Positive Interim Safety Data From Spinal Cord Injury Trial

Recommendation and review posted by sam

SAN DIEGO, May 17, 2012 /PRNewswire/ -- Cardium Therapeutics (NYSE MKT: CXM) today announced that Christopher J. Reinhard, Chairman & CEO will present a corporate overview and participate in a Regenerative Medicine Panel being held at the Sachs 2012 Science, Partner, and Investment Forum: Gateway for the Global Life Sciences in West Palm Beach, FL May 21 22, 2012. The Regenerative Medicine Panel, chaired by Bernard Siegel, Executive Director, Genetics Policy Institute and Jeffrey Cohen, Director, Ladenburg Thalmann & Co, Inc., will take place on May 22 at 9:15 a.m. ET and Cardium's investor presentation is scheduled for 10:40 a.m. ET on the same day in Ballroom B.

(Logo: http://photos.prnewswire.com/prnh/20051018/CARDIUMLOGO)

An updated investor presentation is now available on Cardium's website at http://phx.corporate-ir.net/phoenix.zhtml?c=77949&p=irol-presentations.

About Cardium

Cardium is a health sciences and regenerative medicine company focused on the acquisition and strategic development of new and innovative bio-medical product opportunities and businesses with the potential to address significant unmet medical needs that have definable pathways to commercialization, partnering and other economic monetizations. Cardium's current medical opportunities portfolio, which is focused on health sciences and regenerative medicine, includes the Tissue Repair Company, Cardium Biologics, and the Company's in-house MedPodium Health Sciences healthy lifestyle product platform. The Company's lead commercial product Excellagen topical gel for wound care management recently received FDA clearance for marketing and sale in the United States. Cardium's lead clinical development product candidate Generx is a DNA-based angiogenic biologic intended for the treatment of patients with myocardial ischemia due to coronary artery disease. In addition, consistent with its capital-efficient business model, Cardium continues to actively evaluate new technologies and business opportunities. In July 2009, Cardium completed the sale of its InnerCool Therapies medical device business to Royal Philips Electronics, the first asset monetization from the Company's biomedical investment portfolio. News from Cardium is located at http://www.cardiumthx.com.

Forward-Looking Statements

Except for statements of historical fact, the matters discussed in this press release or the referenced investor presentation are forward looking and reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond our control and may cause actual results to differ materially from expectations. For example, there can be no assurance that results or trends observed in one clinical study or procedure will be reproduced in subsequent studies or in actual use; that new clinical studies will be successful or will lead to approvals or clearances from health regulatory authorities, or that approvals in one jurisdiction will help to support studies or approvals elsewhere; that the company can attract suitable commercialization partners for our products or that we or partners can successfully commercialize them; that our product or product candidates will not be unfavorably compared to competitive products that may be regarded as safer, more effective, easier to use or less expensive or blocked by third party proprietary rights or other means; that the products and product candidates referred to in this report or in our other reports will be successfully commercialized or will enhance our market value; that new product opportunities or commercialization efforts will be successfully established; that third parties on whom we depend will perform as anticipated; that we can raise sufficient capital from partnering, monetization or other fundraising transactions to maintain our stock exchange listing or adequately fund ongoing operations; or that we will not be adversely affected by these or other risks and uncertainties that could impact our operations, business or other matters, as described in more detail in our filings with the Securities and Exchange Commission. We undertake no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof.

Copyright 2012 Cardium Therapeutics, Inc. All rights reserved.

For Terms of Use Privacy Policy, please visit http://www.cardiumthx.com.

Cardium Therapeutics, Generx, Cardionovo, Tissue Repair, Gene Activated Matrix, GAM, Excellagen, Excellarate, Osteorate, MedPodium, Appexium, Linee, Alena, Cerex, D-Sorb, Neo-Energy, Neo-Carb Bloc, Neo-Chill, and Nutra-Apps are trademarks of Cardium Therapeutics, Inc. or Tissue Repair Company.

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Cardium to Present at Sachs Associates 2012 Science, Partner, and Investment Forum: Gateway for the Global Life Sciences

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Posted May 17, 2012

Awards to advance regenerative medicine address diverse, debilitating diseases and conditions

COLUMBIA, Md. - The Maryland Stem Cell Research Commissionhas completed its review of the 179 applications received in response to its three FY 2012 Requests for Applications (RFAs). The board of directors of the Maryland Technology Development Corporation (TEDCO) approved the Commission's recommendation to fund 40 new proposals with the Maryland Stem Cell Research Fund's (MSCRF) $12.4 million FY 2012 budget.

"We are pleased to announce our grant awards for FY 2012," said Margaret Conn Himelfarb, MPH, chair of the Commission. "These projects address a diverse array of debilitating and costly diseases and conditions, some of which are traditionally underfunded. Maryland's investment in cutting-edge stem cell research continues to advance the field and strengthens our State's national leadership position in the life sciences. We are grateful to Governor Martin O'Malley and the Maryland General Assembly for recognizing the tremendous economic and humanitarian benefits of this pioneering research."

This funding cycle, the Commission gave priority to proposals that focus on advancing regenerative medicine by selecting promising research that targets sickle cell anemia, schizophrenia, type 1 diabetes, nerve injury, Parkinson's disease, Crohn's disease, multiple sclerosis (MS), heart disease, osteoarthritis, Lou Gehrig's disease (ALS), retinal disease, and other debilitating medical conditions. Continuing the collaboration initiated last year with the California Institute of Regenerative Medicine (CIRM), the MSCRF will also support a Maryland researcher working with CIRM-funded scientists to study stem cell differentiation and bone repair.

This year's MSCRF awards include:

9 Investigator-Initiated Research Grants (RFA-MD-12-1) - providing up to $600,000 in direct costs over a maximum of three years to investigators with preliminary data to support their hypotheses.

17 Exploratory Research Grants (RFA-MD-12-2) - providing up to $200,000 in direct costs over a maximum of two years to researchers with novel approaches, mechanisms or models that may differ from current thinking in the field and/or new hypotheses that have little or no preliminary data.

14 Post-Doctoral Fellowship Research Grants (RFA-MD-12-3) - providing post-doctoral fellows up to $55,000 per year, for up to two years.

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Maryland Stem Cell Research Commission Funds 40 New Proposals in FY 2012

Recommendation and review posted by sam

IRVINE, Calif.--(BUSINESS WIRE)--

California Stem Cell, Inc. (CSC) announced today that well-known stem cell & regenerative medicine industry veteran Gregory A. Bonfiglio, J.D. has joined its Board of Directors.

Gregory Bonfiglio has over 25 years of experience working with technology companies, and was an early investor in the stem cell industry. He is Managing Partner of Proteus Venture Partners, an investment & advisory firm he founded in early 2006 to provide venture funding and strategic advisory services in the stem cell & regenerative medicine space. Mr. Bonfiglio is on the Boards of VistaGen Therapeutics and StemCyte, Inc.; he is the Chairman of the Board of the Centre for Commercialization of Regenerative Medicine (RM Translation Center in Toronto, Canada). In addition, Mr. Bonfiglio sits on the Advisory Board and Finance Committee of the International Society for Stem Cell Research (ISSCR); he is on the Commercialization Committee of the International Society for Cellular Therapy (ISCT).

Mr. Bonfiglio brings to CSC an extensive background in strategic consulting, having held partnership positions with various legal and venture firms, and having successfully led a team that took pioneering stem cell company Advanced Cell Technology public in early 2005. Were thrilled to welcome to our board someone with the breadth of industry experience that Greg has, and are very much looking forward to his participation in the continued growth of this Company, said COO Chris Airriess.

This appointment coincides with a ramp up of commercial product sales as well as advancements of CSCs active Phase II clinical trial in metastatic melanoma.

About California Stem Cell

California Stem Cell Inc. (CSC) is an Irvine, CA based company which has developed proprietary methods to generate human stem cell lines, expand them to clinically and commercially useful numbers, and differentiate them at extremely high purity using fully-defined, proprietary media and GMP processes. CSC is able to supply its human cell populations to companies and institutions worldwide for use in the development of therapies, efficacy screening or the creation of toxicity profiles for candidate drugs, and experimental research tools.

CSC is focused on the development of stem cell based therapies for spinal muscular atrophy (SMA), amyotrophic lateral sclerosis (ALS, or Lou Gehrigs Disease), and metastatic cancers.

Follow us on Twitter: http://twitter.com/castemcell

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Industry Consultant Gregory Bonfiglio Joins California Stem Cell Board of Directors

Recommendation and review posted by sam

ANN ARBOR, Mich., May 17, 2012 (GLOBE NEWSWIRE) -- Aastrom Biosciences, Inc. (Nasdaq:ASTM - News), the leading developer of patient-specific expanded multicellular therapies for the treatment of severe chronic cardiovascular diseases, today announced that company president and CEO Tim Mayleben will be presenting at the World Stem Cells & Regenerative Medicine Congress at the Park Plaza hotel in London, UK. The presentation entitled "Phase 3 Development of a Cellular Therapy Product" will take place on Monday, May 21, 2012 at 4:40 pm (BST).

The Aastrom presentation will cover the benefits of a special protocol assessment and offer insights on achieving manufacturing readiness. The presentation will also address the role of clinicians and patients in the Phase 3 development process.

About Aastrom Biosciences

Aastrom Biosciences is the leader in developing patient-specific, expanded multicellular therapies for use in the treatment of patients with severe, chronic cardiovascular diseases. The company's proprietary cell-processing technology enables the manufacture of ixmyelocel-T, a patient-specific multicellular therapy expanded from a patient's own bone marrow and delivered directly to damaged tissues. Aastrom has advanced ixmyelocel-T into late-stage clinical development, including a Phase 3 clinical program to study patients with critical limb ischemia and a planned Phase 2b clinical trial in patients with ischemic dilated cardiomyopathy. For more information, please visit Aastrom's website at http://www.aastrom.com. For more information on the pivotal REVIVE Phase 3 clinical trial, please visit the trial website at http://www.revivecli.com.

The Aastrom Biosciences, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3663

This document contains forward-looking statements, including, without limitation, statements concerning clinical trial plans and progress, objectives and expectations, clinical activity timing, intended product development, the performance and contribution of certain individuals and expected timing of collecting and analyzing treatment data, all of which involve certain risks and uncertainties. These statements are often, but are not always, made through the use of words or phrases such as "anticipates," "intends," "estimates," "plans," "expects," "we believe," "we intend," and similar words or phrases, or future or conditional verbs such as "will," "would," "should," "potential," "could," "may," or similar expressions. Actual results may differ significantly from the expectations contained in the forward-looking statements. Among the factors that may result in differences are the inherent uncertainties associated with clinical trial and product development activities, regulatory approval requirements, competitive developments, and the availability of resources and the allocation of resources among different potential uses. These and other significant factors are discussed in greater detail in Aastrom's Annual or Transition Report on Form 10-K or 10-K/T, Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. These forward-looking statements reflect management's current views and Aastrom does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this release except as required by law.

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Aastrom Biosciences to Present at World Stem Cells & Regenerative Medicine Congress

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MARLBOROUGH, Mass.--(BUSINESS WIRE)--

Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that chairman and CEO Gary Rabin will be presenting at the World Stem Cells and Regenerative Medicine Conference, May 21-23, in London.

Mr. Rabins presentation, titled Successes and ongoing advancements of human clinical trials for the treatment of AMD & Stargardts Disease, will be given on Monday, May 21 at 5:05 p.m. BST (London time). Mr. Rabin will provide an update on ACTs three ongoing human clinical trials in the U.S. and E.U. for Dry Age-Related Macular Degeneration (Dry AMD) and Stargardts Macular Dystrophy (SMD).

ACT recently announced Data and Safety Monitoring Board (DSMB) approval to move forward with enrollment and treatment of additional patients with SMD in its U.S. SMD trial, and to treat the final two patients to round out the initial dosing arm in its European trial. All three of the companys ongoing clinical trials use human embryonic stem cell (hESC)-derived retinal pigment epithelial (RPE) cells.

About SMD, Dry AMD and Degenerative Diseases of the Retina

Stargardts Macular Dystrophy (SMD) is one of the most common forms of macular degeneration in the world. SMD causes progressive vision loss, usually starting in children between 10 to 20 years of age. Eventually, blindness results from photoreceptor loss associated with degeneration in the pigmented layer of the retina, called the retinal pigment epithelium or RPE cell layer.

Degenerative diseases of the retina are among the most common causes of untreatable blindness in the world. As many as thirty million people in the United States and Europe suffer from macular degeneration, which represents a $25-30 billion worldwide market that has yet to be effectively addressed. Approximately 10% of people ages 66 to 74 will have symptoms of macular degeneration, the vast majority the dry form of AMD which is currently untreatable. The prevalence increases to 30% in patients 75 to 85 years of age.

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc., is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit http://www.advancedcell.com.

Forward-Looking Statements

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Advanced Cell Technology to Present at World Stem Cells & Regenerative Medicine Congress in London

Recommendation and review posted by sam

Pluristem Therapeutics Ltd. (Nasdaq:PSTI; DAX: PJT: PLTR) today reported that the cardiac function in a diabetic-induced diastolic dysfunction in animals improved following PLacental eXpanded (PLX cells) administration.

The study was conducted as part of the European Commission's Seventh Framework Program (FP7) in collaboration with Prof. Doctor Carsten Tschope and his staff at the Charite Universitaetsmedizin Berlin, Berlin-Bradenburg Center for Regenerative Therapies (BCRT), Berlin, Germany.

Dr. Tschope said, "Currently, there are limited treatment options for diastolic dysfunction and even fewer options for diabetic induced diastolic dysfunction. This study holds promise that PLX cells might be able to inhibit diabetic induced diastolic dysfunction progression as well as possibly repair the existing damage, hypotheses that will be further explored in future studies."

Diabetes was induced in thirty-six mice resulting in the development of diastolic heart failure. After seven days, the animals received either PLX cells from two separate batches or placebo (12 subjects in each of the three groups). Ten mice were not treated (controls).

After three weeks, several cardiac parameters were assessed and found to be significantly improved following the treatment with PLX cells. Important measurements included the cardiac ejection fraction and the left ventricular (LV) relaxation time constant, believed to be the best index of LV diastolic function and a determination of the stiffness of the ventricle. Cardiac ejection fraction improved 19%, the left ventricular relaxation time constant fell 16% and stiffness of the ventricle fell 19%.

Administration of either batch of PLX cells also resulted in a significant anti-inflammatory effect.

Pluristem chairman and CEO Zami Alberman said, "As we demonstrated last week with the announcement that our cells successfully treated the seven year old patient suffering from aplastic bone marrow disease, our strategy is to develop a minimally invasive cell therapy solution that can be used to treat a wide range of life-threatening diseases. Our initial testing of a treatment for diastolic heart disease opens a new potential indication where our cells can be used and potentially positions Pluristem as a "first-line of defense" for diastolic dysfunction."

Pluristem's share price jumped 5.6% in pre-market trading on Nasdaq to $3.01, giving a market cap of $126.33 million. The share rose 10.6% on the TASE today to NIS 11.50.

Published by Globes [online], Israel business news - http://www.globes-online.com - on May 15, 2012

Copyright of Globes Publisher Itonut (1983) Ltd. 2012

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Pluristem trial finds stem cells improve cardiac dysfunction

Recommendation and review posted by Bethany Smith

Cell surface protein blows potent cells cover; targeted drug works in preclinical tests

Newswise HOUSTON Breast cancer stem cells wear a cell surface protein that is part nametag and part bulls eye, identifying them as potent tumor-generating cells and flagging their vulnerability to a drug, researchers at The University of Texas MD Anderson Cancer Center report online in Journal of Clinical Investigation.

Weve discovered a single marker for breast cancer stem cells and also found that its targetable with a small molecule drug that inhibits an enzyme crucial to its synthesis, said co-senior author Michael Andreeff, M.D., Ph.D., professor in MD Andersons Departments of Leukemia and Stem Cell Transplantation and Cellular Therapy.

Andreeff and colleagues are refining the drug as a potential targeted therapy for breast cancer stem cells, which are thought to be crucial to therapy resistance, disease progression and spread to other organs.

Its been difficult to identify cancer stem cells in solid tumors, Andreeff said. And nobody has managed to target these cells very well.

The marker is the cell surface protein ganglioside GD2. The drug is triptolide, an experimental drug that Andreeff has used in preclinical leukemia research. The team found triptolide blocks expression of GD3 synthase, which is essential to GD2production.

Triptolide stymied cancer growth in cell line experiments and resulted in smaller tumors and prolonged survival in mouse experiments. Drug development for human trials probably will take several years.

Cancer stem cells are similar to normal stem cells

Research in several types of cancer has shown cancer stem cells are a small subpopulation of cancer cells that are capable of long-term self-renewal and generation of new tumors. More recent research shows they resist treatment and promote metastasis.

Cancer stem cells are similar to normal stem cells that renew specialized tissues. The breast cancer findings grew out of Andreeffs long-term research in mesenchymal stem cells, which can divide into one copy of themselves and one differentiated copy of a bone, muscle, fat or cartilage cell.

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Scientists Discover Marker to Identify, Attack Breast Cancer Stem Cells

Recommendation and review posted by Bethany Smith

To get your name on a bone marrow donor registry list takes just a couple drops of blood.

STORY HIGHLIGHTS

(CNN) -- Registering to become a bone marrow donor just became as simple as tending to a paper cut.

Help Remedies, a small health care products company, has recently teamed up with DKMS, the world's largest bone marrow donor center, to release Help: I Want to Save a Life. The product contains 16 adhesive bandages and a bone marrow testing kit.

Now when people cut themselves and search for a bandage they can dab their blood with a cotton swab, place it in the pre-packaged envelope, and mail it into the lab. After mailing in the kit, people fill out a brief form online and are instantly added to the United States national bone marrow registry, called Be the Match.

"The magic of this idea is that it just feels like it's part of the process," said Nathan Frank, co-founder and creative director of Help Remedies. "You cut yourself, you dip it [the test] in blood. You don't step out of what you're doing physically or mentally."

According to the National Marrow Donor Program, more than 10,000 people in the United States are diagnosed with diseases every year, the only cure being a bone marrow transplant from an unrelated donor. Patients need donors who are a close genetic match, and ethnicity/heritage are key in making that match.

The Be the Match Registry has more than 9.5 million donors (300,000 of whom are associated with DKMS), but only one in 540 will be matched with a patient in need. Help Remedies and DKMS are hoping to improve those statistics.

Part of this product's appeal is that customers can purchase Help: I Want to Save a Life and satisfy their altruistic side without paying extra. Customers pay $4, the cost of the bandages.

"It is basically an add-on and people can have the benefit of the kit without paying extra," Frank said. "They shouldn't have to pay extra to do something good. We wanted to give this as a gift to people."

Continue reading here:
Get a paper cut, save a life

Recommendation and review posted by Bethany Smith

What if your very own bone marrow stem cells, upgraded with more immune cells, could be used to increase your chances of survival after a heart attack? Sounds like the stuff of science fiction, but according to a study done by Timothy Henry, MD of the Minneapolis Heart Institute and colleagues, it may in fact be possible. The findings, which were presented at the Society for Cardiovascular Angiography, are considered preliminary until they are published in a peer-reviewed journal, but they are definitely promising.

"With stem cells, we've been successful with processes that improve blood flow," Henry told MedPage Today, and added that there is a significant number of class III heart failure patients who don't do well on medications or with devices.

"A therapy that would delay heart failure progression would be a major step forward," he said. "This small trial proved the intervention is safe and all the trends were in the right direction."

The next phase of the trial will begin in the summer. Stay tuned!

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Stem Cells May Help Heart Patients

Recommendation and review posted by Bethany Smith

CARLSBAD, Calif.--(BUSINESS WIRE)--

International Stem Cell Corporation (OTCBB: ISCO.OB - News) (www.internationalstemcell.com) today announced financial results for the three months ended March 31, 2012.

Three Months ended March 31, 2012

Consolidated net revenues for the three months ended March 31, 2012 were $1.08 million compared to $1.52 million in the corresponding period a year ago. The year-over-year decrease in revenues is due to fewer sales generated from the Lifeline Skin Care (LSC) direct sales channel, partially offset by higher Lifeline Cell Technology (LCT) sales generated from larger distributors. LSC and LCT accounted for 51% and 49% of total revenue in the three months ended March 31, 2012 compared to 75% and 25%, respectively, in the comparable period a year ago.

For the three months ended March 31, 2012, development expenses were $3.80 million, representing a decrease of approximately 5% compared to the corresponding period in 2011. The decrease primarily reflects lower general and administrative expenses resulting from decreased stock-based compensation expense and lower laboratory-related expenses. The decrease was partially offset by higher cost of sales ratio resulting from increased sales concentration of lower margin products, and higher marketing and selling expense related to LSC. The Company continued to invest in its sales and marketing infrastructure, including significant enhancements to the e-commerce platforms, increased advertising and strengthening the sales and customer service organization.

Cash and cash equivalents at March 31, 2012 were $6.01 million compared to $1.34 million at December 31, 2011, reflecting an increase of $4.67 million resulting from two financing transactions including the issuance of shares of Series G preferred stock for $5.00 million and issuance of shares of common stock for a total of $2.08 million in the first quarter of 2012.

Q1 2012 Business Highlights:

The Company continued to focus its research and development efforts on the creation of additional parthenogenetic stem cell lines for therapeutic use and on the advancement of the disease area research programs, particularly pre-clinical in vivo safety and efficacy studies in Parkinsons disease and new methods for high-throughput cell culture and stem cell differentiation.

ISCOs wholly-owned subsidiary Lifeline Skin Care drove sales by expanding acquisition of both retail and trade customers, increasing the average order value and enhancing customer loyalty and retention. New retail customers were attracted by an increased social media presence and national exposure on TV shows such as ABCs The Talk and the use of risk-free introductory offers and free sample promotions. In addition, LSC continued to increase the number of strategic marketing partnerships. Although LSC revenue for the quarter was lower than the same period in 2011, the sales were generated from more diversified sources with much greater growth potential and reduced reliance on individual third parties.

Lifeline Cell Technology, ISCOs wholly-owned subsidiary specialized in cells and media research products, grew revenue across all three sales channels including domestic, international and OEM, showing a 39% increase over the same quarter of 2011.

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International Stem Cell Corp Announces First Quarter 2012 Financial Results and Business Highlights

Recommendation and review posted by Bethany Smith

CARLSBAD, Calif.--(BUSINESS WIRE)--International Stem Cell Corporation (OTCBB: ISCO) (www.internationalstemcell.com) today announced that several of its leading scientists will present experimental results from three of ISCOs pre-clinical therapeutic programs.

These results not only show the progress we have made in these important programs, but also demonstrate the broad application of human parthenogenetic stem cells in the development of treatments for incurable diseases

Firstly, the application of A9 dopaminergic neurons derived from human parthenogenetic stem cells (hpSC) for the treatment of Parkinsons disease. Demonstrating functional dopaminergic neurons in vivo represents an important milestone towards the goal of creating well characterized populations of cells that could be used to develop a treatment for Parkinsons.

Secondly, the differentiation of hpSC and embryonic stem cells into cornea-like constructs for use in transplantation therapy and the in vitro study of ocular drug absorption. There are approximately ten million people worldwide who are blind as a result of damage to their cornea. Generating human corneas from a pluripotent stem cell source should increase the likelihood that people will receive treatment in the future even in the absence of suitable tissue from eye banks.

Lastly, the in vivo and in vitro characterization of immature hepatocyte derived from hpSC. Such cells could be used to develop a treatment for individuals with a liver that has been damaged by disease or sufferers of genetic disorders that inhibit normal liver function. In both cases, implanting healthy hepatocyte cells could treat the underlying disease and prolong the life of the individual.

These results not only show the progress we have made in these important programs, but also demonstrate the broad application of human parthenogenetic stem cells in the development of treatments for incurable diseases, says Dr. Ruslan Semechkin, Vice President of Research and Development.

The presentations will take place at the 15th Annual Meeting of American Society of Gene and Cell Therapy, in Philadelphia at 3:30 p.m. on Thursday, May 17th.

About International Stem Cell Corporation

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

To receive ongoing corporate communications, please click on the following link: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0

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International Stem Cell Corporation Scientists to Present Pre-Clinical Research Results at American Society of Gene ...

Recommendation and review posted by Bethany Smith

By Carolyn Y. Johnson, Globe Staff

Two teams of Boston scientists have developed new ways to turn stem cells into different types of lung tissue, surmounting a major hurdle for scientists trying to harness the power of stem cell biology to study and develop treatments for major lung diseases.

One team then used skin cells from cystic fibrosis patients to create embryonic-like stem cells, then working in lab dishes used those cells to grow tissue that lines the airways and contains a defect responsible for the rare, fatal disease. The technique -- essentially a recipe for growing such lung tissue -- could provide a powerful platform to screen drugs and study the biology of the disease.

Growing lung tissue in the laboratory has long been a goal of stem cell scientists, but has been more technically difficult than growing other types of tissues, such as brain cells or heart cells. Such lung tissue is valuable because it could be used to screen potential drugs and more closely probe the problems that underlie diseases such as asthma, emphysema, and rare genetic diseases. Such techniques may also one day help researchers grow replacement tissues and devise ways to restore or repair injured lung tissue.

A team led by Massachusetts General Hospital researchers created lung tissue from a patient with the genetic mutation that most commonly underlies cystic fibrosis and researchers hope the technique will also be a powerful tool to study other diseases that affect the airway tissue, such as asthma and lung cancer. The other team, led by Boston University School of Medicine scientists, was able to derive cells that form the delicate air sacs of the lung from mouse embryonic stem cells. The team is hoping to refine the recipe for making the cells so that they can be used to derive lung tissue from a bank of 100 stem cell lines of patients with lung disease. Both papers were published Thursday in the journal Cell Stem Cell.

Vertex Pharmaceuticals, a Cambridge biotechnology company, earlier this year received approval for Kalydeco -- the first drug to directly target the underlying cause of cystic fibrosis. That compound was discovered by screening massive numbers of potential drugs against cells engineered to carry the same defect that underlies cystic fibrosis.

We had to use engineered cells, and certainly using more native human cells ... would be potentially beneficial, said Dr. Frederick Van Goor, head of biology for Vertexs cystic fibrosis research program. We had to rely on donor tissue obtained from patients with cystic fibrosis, and its a bit more challenging, because the number of donor lungs you can get and the number of cells you can derive from there are more limited.

Van Goor said it was too soon to say whether the company would use the new technology in screening, but noted that the tests the company had used to determine whether a drug was likely to work against the disease had, in some cases, given scientists false leads. Some molecules that worked on the engineered cells did not work in the complicated biology of the lung.

Its a significant event for the lung field, said Dr. Thiennu Vu, associate professor of medicine at the University of California San Francisco, who was not involved in the research. She added that much work remains before such cells could be used to repair or replace damaged tissue, and even before such cells would necessarily be useful for drug screening. It will be important, she said, to refine the recipe to ensure that the technique yields pure populations of the specific types of functional lung cells.

In the competitive world of science, where credit for being the first to do something is crucially important, the two research teams accomplishments are an unusual example of competitors turning into collaborators -- forging a relationship that both teams felt helped speed up progress.

Originally posted here:
Boston scientists grow lung tissue from cystic fibrosis patients’ skin cells

Recommendation and review posted by Bethany Smith

NEW YORK--(BUSINESS WIRE)--

Pfizer Inc announced today that the Phase 3 INTORSECT (B1771003) study, evaluating TORISEL (temsirolimus) in patients with advanced renal cell carcinoma (RCC) whose disease had progressed on or after SUTENT (sunitinib malate) therapy, did not meet the primary endpoint of prolonging progression free survival (PFS) when compared to sorafenib. Although PFS was numerically higher in patients treated with temsirolimus, the difference was not statistically significant. Overall survival, a secondary endpoint in the study, showed statistical significance favoring patients randomized to the sorafenib arm. Adverse events in this study were consistent with the known safety profiles for both drugs. Full efficacy and safety data from this study will be presented at an upcoming major medical congress.

Approximately 270,000 people worldwide are diagnosed with renal cell cancer every year with about 20 percent having advanced disease at the time of diagnosis.1 Between 40 and 65 percent of patients in the U.S. who progress following first-line therapy go on to receive a second-line treatment.2,3,4

This trial advances our knowledge about TORISEL in RCC. TORISEL remains an important drug for treatment of advanced kidney cancer based on its pivotal study in first-line patients with poor prognostic risk, said Dr. Mace Rothenberg, senior vice president of clinical development and medical affairs for Pfizers Oncology Business Unit. TORISEL continues to be an important part of Pfizers portfolio of therapies for advanced kidney cancer.

About TORISEL (temsirolimus)

TORISEL is approved in the US and other countries for the treatment of advanced RCC. TORISEL is approved in the European Union for the first-line treatment of patients with advanced renal cell carcinoma (RCC) who have at least three of six prognostic risk factors. In a pivotal Phase 3 study, TORISEL demonstrated median overall survival (OS) in previously untreated patients of 10.9 months in patients with advanced RCC with poor prognostic risk, compared with 7.3 months for interferon-alpha (IFN-).

TORISEL is the only intravenous mammalian target of rapamycin (mTOR) inhibitor approved for the treatment of advanced RCC. TORISEL remains the only treatment to show a significant improvement in OS in treatment-nave poor risk patients with advanced RCC.5

Based on preclinical studies, TORISEL inhibits the activity of mTOR, an intracellular protein implicated in multiple growth-related cellular functions including proliferation, growth and survival. The inhibition of mTOR also reduces levels of certain growth factors, such as vascular endothelial growth factor (VEGF), which are overexpressed in solid tumors like kidney cancer and are thought to play a crucial role in angiogenesis, the process by which tumors acquire blood vessels, nutrients and oxygen needed for growth.

Important TORISEL (temsirolimus) Safety Information

TORISEL is contraindicated in patients with bilirubin >1.5 x ULN and should be used with caution when treating patients with mild hepatic impairment (bilirubin >1 1.5 x ULN or AST > ULN but bilirubin ULN). If TORISEL must be given to patients with mild hepatic impairment, reduce the dose of TORISEL to 15 mg/week. In a phase 1 study, the overall frequency of grade 3 adverse reactions and deaths, including deaths due to progressive disease, was greater in patients with baseline bilirubin > 1.5 x ULN.

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Pfizer Provides Topline Results From Phase 3 Study Of Torisel® As Second-Line Treatment In Advanced Renal Cell ...

Recommendation and review posted by Bethany Smith

LEUVEN, BELGIUM--(Marketwire -05/15/12)- TiGenix NV (TIG) a leader in the field of cell therapy, today gave a business update and announced the financial results for the first quarter ending March 31, 2012.

Business highlights

Financial highlights

"In the first quarter 2012 we continued to aggressively push our commercial efforts forward," said Eduardo Bravo, CEO of TiGenix. "As a result sales of ChondroCelect are developing in line with the improved traction we observed in the second part of last year. At the same time we are moving ahead of schedule with most of our clinical adipose stem cell programs. We closed the quarter with almost EUR 17 million cash on hand, which is sufficient to execute on our business plan and reach key inflection points."

Business update

ChondroCelect sales increase continues apaceThe Company reports net sales growth for the quarter of 123% compared with the same period of last year, and of 62% compared to Q4, 2011, a positive trend reflecting the uptake in Belgium, where we benefit from national reimbursement. In the Netherlands one of the leading private healthcare insurance companies has made treatment with ChondroCelect compulsory for its insured, and no longer reimburses non-ATMP treatments. Similarly, one of the large private insurers in the UK has expressed its intention to routinely reimburse ChondroCelect going forward. Discussions to obtain full national reimbursement keep advancing in the Netherlands, France, Spain and Germany.

Positive outcome of ChondroCelect compassionate use program published in leading journalPositive outcome data from the ChondroCelect compassionate use program (CUP), involving 43 orthopedic centers in 7 European countries, treating 370 patients with ChondroCelect over the span of four years, were published in advance online in Cartilage, the official journal of the International Cartilage Repair Society. The data show that the implantation of ChondroCelect results in a positive benefit/risk ratio when used in an unselected, heterogeneous population, irrespective of the follow-up period, lesion size and type of lesion treated. In addition, the CUP study significantly expands the data set used to obtain approval for ChondroCelect from the European Medicines Agency in 2009, increasing eight-fold, from 43 to 334, the number of patients with long-term follow up data. To date almost 700 patients have been treated with ChondroCelect.

ADMIRE-CD Phase III trial (Cx601) in complex perianal fistula on schedule The ADMIRE-CD (Adipose Derived Mesenchymal stem cells for Induction of REmission in perianal fistulizing Crohn's Disease) Phase III protocol was submitted to Ethics Committees or Health Authorities in all 8 participating countries, and to date approvals have been received in four of those countries already.

Cx611 Phase IIa in RA passes last safety hurdleOn April 17, upon review of the safety data of the first three patients of the third cohort of the company's Phase IIa clinical trial in rheumatoid arthritis (Cx611), TiGenix received the go-ahead from the independent Safety Monitoring Board to recruit and dose the remaining patients of this cohort. This fact is of major importance. In RA it ensures that the product will not be held back by any dose-limiting factors and that we will be able to move forward with the optimal treatment dose. Of almost equal importance is that, if required, we can expand the dosing range in other indications that we are exploring as well. With 6 months of follow-up, the current RA trial in 53 patients is expected to report meaningful results in H1 2013.

Last patient treated in Cx621 Phase I clinical trialAll 10 healthy volunteers have been recruited and treated in the Phase I study of Cx621. Cx621 investigates the safety and feasibility of intra-lymphatic administration of stem cells. Intra-lymphatic administration of (all) stem cells is patented by TiGenix. The final report of this trial will be available at the end of June.

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TiGenix Reports Business & Financial Results for the First Quarter 2012

Recommendation and review posted by Bethany Smith

JERUSALEM--(BUSINESS WIRE)--

Gamida Cell announced today that it has closed an internal E financing round of $10 million. All major shareholders participated.

The financing will be used to support the global commercialization of the companys lead cell therapy product, StemEx, in development as an alternative therapeutic treatment for patients with blood cancers, such as leukemia and lymphoma, who can be cured by bone marrow transplantation but do not have a matched bone marrow donor. The company is currently seeking a strategic partner to join in the global commercialization of StemEx.

The financing will also support the continued development of the companys pipeline of products, primarily the NiCord clinical trial for sickle cell disease and thalassemia.

Mr. Reuven Krupik, chairman of the board of Gamida Cell said, The investors were unanimous in their decision to reinvest, understanding the importance of bringing StemEx to market as well as maintaining the companys leadership role in the stem cell industry. Gamida Cell is a game changer.

The international, multi-center, pivotal registration, Phase III clinical trial of StemEx completed enrollment in February 2012. Clinical outcome is expected in Q4/2012. The market launch of StemEx is planned for 2013. StemEx is likely to be the first allogeneic stem cell product in the market. StemEx is being developed by the Gamida Cell-TEVA joint venture.

Dr. Yael Margolin, president and chief executive officer of Gamida Cell said, With the continued support of our shareholders and the analysis of the clinical results of the StemEx trial just around the corner, we are now focused on submitting the BLA.

StemEx is a graft of an expanded population of stem/progenitor cells, derived from part of a single unit of umbilical cord blood and transplanted by IV administration along with the remaining, non-manipulated cells from the same unit. Competing products in development use two units. As the average cost of a cord blood unit in the U.S. is $40K, StemEx is expected to be a significantly less expensive treatment option. StemEx is also expected to be available in the market several years before any of the competing products.

About Gamida Cell

Gamida Cell is a world leader in stem cell population expansion technologies and stem cell therapy products for transplantation and regenerative medicine. The companys pipeline of stem cell therapy products are in development to treat a wide range of conditions including blood cancers, solid tumors, non-malignant hematological diseases such as hemoglobinopathies, neutropenia and acute radiation syndrome, autoimmune diseases and metabolic diseases as well as conditions that can be helped by regenerative medicine. Gamida Cells therapeutic candidates contain populations of adult stem cells, selected from non-controversial sources such as umbilical cord blood, bone marrow and peripheral blood, which are expanded in culture. Gamida Cells current shareholders include: Elbit Imaging, Clal Biotechnology Industries, Israel Healthcare Venture, Teva Pharmaceutical Industries, Amgen, Denali Ventures and Auriga Ventures. For more information, please visit: http://www.gamida-cell.com.

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Gamida Cell Closes $10 Million E Financing Round Earmarked to Support the Global Commercialization of the Company’s ...

Recommendation and review posted by Bethany Smith

Public release date: 14-May-2012 [ | E-mail | Share ]

Contact: Juan J. Gomez juanj.gomez@cnio.es 34-917-328-000-4060 Centro Nacional de Investigaciones Oncologicas (CNIO)

A number of studies have shown that it is possible to lengthen the average life of individuals of many species, including mammals, by acting on specific genes. To date, however, this has meant altering the animals' genes permanently from the embryonic stage an approach impracticable in humans. Researchers at the Spanish National Cancer Research Centre (CNIO), led by its director Mara Blasco, have proved that mouse lifespan can be extended by the application in adult life of a single treatment acting directly on the animal's genes. And they have done so using gene therapy, a strategy never before employed to combat ageing. The therapy has been found to be safe and effective in mice.

The results are published today in the journal EMBO Molecular Medicine. The CNIO team, in collaboration with Eduard Ayuso and Ftima Bosch of the Centre of Animal Biotechnology and Gene Therapy at the Universitat Autnoma de Barcelona (UAB), treated adult (one-year-old) and aged (two-year-old) mice, with the gene therapy delivering a "rejuvenating" effect in both cases, according to the authors.

Mice treated at the age of one lived longer by 24% on average, and those treated at the age of two, by 13%. The therapy, furthermore, produced an appreciable improvement in the animals' health, delaying the onset of age-related diseases like osteoporosis and insulin resistance and achieving improved readings on ageing indicators like neuromuscular coordination.

The gene therapy utilised consisted of treating the animals with a DNA-modified virus, the viral genes having been replaced by those of the telomerase enzyme, with a key role in ageing. Telomerase repairs the extremes of chromosomes, known as telomeres, and in doing so slows the cell's and therefore the body's biological clock. When the animal is infected, the virus acts as a vehicle depositing the telomerase gene in the cells.

This study "shows that it is possible to develop a telomerase-based anti-ageing gene therapy without increasing the incidence of cancer", the authors affirm. "Aged organisms accumulate damage in their DNA due to telomere shortening, [this study] finds that a gene therapy based on telomerase production can repair or delay this kind of damage", they add.

'Resetting' the biological clock

Telomeres are the caps that protect the end of chromosomes, but they cannot do so indefinitely: each time the cell divides the telomeres get shorter, until they are so short that they lose all functionality. The cell, as a result, stops dividing and ages or dies. Telomerase gets round this by preventing telomeres from shortening or even rebuilding them. What it does, in essence, is stop or reset the cell's biological clock.

But in most cells the telomerase gene is only active before birth; the cells of an adult organism, with few exceptions, have no telomerase. The exceptions in question are adult stem cells and cancer cells, which divide limitlessly and are therefore immortal in fact several studies have shown that telomerase expression is the key to the immortality of tumour cells.

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CNIO scientists successfully test the first gene therapy against aging-associated decline

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Barbara Netter, co-founder of the Alliance for Cancer Gene Therapy, receives the first-ever ACGT Partnership Award from Savio Woo, chairman of the Alliance's scientific council and professor and founding chair of the Department of Gene and Cell Medicine at Mt. Sinai School of Medicine.

Photo credit: Courtesy of Elaine Ubia

GREENWICH, Conn. The Greenwich-based Alliance for Cancer Gene Therapy celebrated its 10th anniversary of funding cancer gene therapy research with a gala benefit last month.

Thirty of the nations top cancer research scientists and more than 450 Alliance supporters gathered on April 19 to mark the progress made in the field. The event raised more than $1.4 million, all of which will go directly to funding new grants and clinical trails.

The alliance also honored the life of its visionary co-founder, Edward Netter, who died last year, by presenting the first ever ACGT Partnership award to Netter's wife, Barbara, who co-founded the alliance with her husband.

Ed epitomized the innovative thinker and problem solver, and he felt it important to examine the status quo, Barbara Netter said in a prepared statement. He had the perseverance to pursue a better way. Our progress, our recent breakthrough, is proving to be a fitting tribute and legacy to Ed, who worked tirelessly and passionately to this end. Ed Netter was a key figure in accelerating research and bringing us to this point.

Prior to the evenings festivities many of the nations leading cancer researchers held a scientific symposium, where they discussed the alliances progress as a leader in the field, as well as how to bridge the gap between the lab and bringing science to patients.

Robert Bazell, the Emmy award-winning chief science and health correspondent for NBC News, was the keynote speaker. Dr. Dennis Clegg, professor, Department of Molecular, Cellular and Developmental Biology, University of California, Santa Barbara, California, was the featured scientist at the dinner.

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Greenwich Cancer Research Group Raises $1.4M

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