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FDA Clears Life Technologies' OpTmizer™ T-Cell Growth Medium for Use in Clinical Trials

Posted: Published on September 28th, 2012

CARLSBAD, Calif., Sept. 27, 2012 /PRNewswire/ --Life Technologies Corporation (LIFE) today announced it has received FDA 510(k) clearance for its OpTmizer CTS T-Cell Expansion Tissue Culture Medium a reagent that is now cleared as a Class II medical device and offers cost- and time-saving advantages for transitioning studies from the research bench to clinical trials. The OpTmizer CTS T-Cell Expansion Tissue Culture Medium is intended for human ex vivo (outside the body) tissue and cell culture processing application. This means it is designed to efficiently grow large numbers of potentially therapeutic T-cells, whichhave demonstrated promise in clinical studies as an effective treatment for diseases including cancer, infectious diseases such as AIDS, and autoimmune disorders. "We are very pleased to learn of Life Technologies' successful outcome in achieving its FDA 510(k) regulatory clearance for its OpTmizer CTS T-Cell Expansion Tissue Culture Medium, and we value the close working relationship we have established with Life Tech," said Neil K. Warma, President & CEO of Opexa Therapeutics, Inc. "The receipt of 510(k) status for OpTmizer CTS T-cell expansion media simplifies the regulatory path for Opexa as we continue the development of Tcelna, a T-cell immunotherapy for the treatment of patients with multiple sclerosis." … Continue reading →

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RBCC: Stem Cell Market Poised for Billion-Dollar Growth

Posted: Published on September 28th, 2012

NOKOMIS, Fla.--(BUSINESS WIRE)-- As Rainbow BioSciences, the biotech subsidiary of Rainbow Coral Corp. (RBCC), works to acquire licensing for commercial use of NASA-developed stem cell expansion technology, the company received good news from a Wall Street analysts forecast on Wednesday. Writing for Seeking Alpha, George Kesarios predicted major growth for the global stem cell market in coming years. Its estimated that the market will be worth about $64 billion by 2015, up from $21.5 billion in 2010. Kesarios attributed the growth largely to a potential revolution in drug companies research and development made possible by an abundance of induced pluripotent stem cells. With these stem cells, scientists can actually create working facsimiles of living human tissue, introduce diseases and observe how they unfold under a microscope, said RBCC CEO Patrick Brown. Spending a decade on research only to discover in trials that a drug doesnt work could become a thing of the past. Stem cells hold the key to the future of profitable, effective drug development. Thats why RBCC has engaged Regenetech in discussions regarding the potential acquisition of a license to perform cell expansion using that companys Rotary Cell Culture SystemTM. The Rotary Cell Culture SystemTM is a rotating-wall … Continue reading →

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Mayo Clinic finds way to weed out problem stem cells, making therapy safer

Posted: Published on September 28th, 2012

Public release date: 27-Sep-2012 [ | E-mail | Share ] Contact: Jennifer Schutz newsbureau@mayo.edu 507-284-5005 Mayo Clinic ROCHESTER, Minn. -- Mayo Clinic researchers have found a way to detect and eliminate potentially troublemaking stem cells to make stem cell therapy safer. Induced Pluripotent Stem cells, also known as iPS cells, are bioengineered from adult tissues to have properties of embryonic stem cells, which have the unlimited capacity to differentiate and grow into any desired types of cells, such as skin, brain, lung and heart cells. However, during the differentiation process, some residual pluripotent or embryonic-like cells may remain and cause them to grow into tumors. "Pluripotent stem cells show great promise in the field of regenerative medicine; however, the risk of uncontrolled cell growth will continue to prevent their use as a therapeutic treatment," says Timothy Nelson, Ph.D., M.D., lead author on the study, which appears in the October issue of STEM CELLS Translational Medicine. Using mouse models, Mayo scientists overcame this drawback by pretreated stem cells with a chemotherapeutic agent that selectively damages the DNA of the stem cells, efficiently killing the tumor-forming cells. The contaminated cells died off, and the chemotherapy didn't affect the healthy cells, Dr. Nelson … Continue reading →

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Deadly complication of stem cell transplants reduced in mice

Posted: Published on September 28th, 2012

ScienceDaily (Sep. 27, 2012) Studying leukemia in mice, researchers at Washington University School of Medicine in St. Louis have reduced a life-threatening complication of stem cell transplants, the only curative treatment when leukemia returns. About 50 percent of leukemia patients who receive stem cells from another person develop graft-versus-host disease, a condition where donor immune cells attack the patient's own body. The main organs affected are the skin, liver and gut. Now, the scientists have shown they can redirect donor immune cells away from these vital organs. Steering immune cells away from healthy tissue also leaves more of them available for their intended purpose -- killing cancer cells. "This is the first example of reducing graft-versus-host disease not by killing the T- cells, but simply by altering how they circulate and traffic," says John F. DiPersio, MD, PhD, the Virginia E. and Sam J. Golman Professor of Medicine. "Donor T-cells do good things in terms of eliminating the recipient's leukemia, but they can also attack normal tissues leading to death in a number of patients. The goal is to minimize graft-versus-host disease, while maintaining the therapeutic graft-versus-leukemia effect." The study is now available online in Blood. Working with mice, Jaebok … Continue reading →

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Research and Markets: Global Erectile Dysfunction Drug Pipeline Capsule – 2012 Update

Posted: Published on September 28th, 2012

DUBLIN--(BUSINESS WIRE)-- Research and Markets (http://www.researchandmarkets.com/research/5cpl3q/global_erectile) has announced the addition of the "Global Erectile Dysfunction Drug Pipeline Capsule - 2012 Update" report to their offering. Fore Pharma's latest report 'Global Erectile Dysfunction Drug Pipeline Capsule - 2012 Update' provides most up-to-date information on key Research and Development activities (R&D) in the global Erectile Dysfunction market. It covers active Erectile Dysfunction pipeline molecules in various stages of clinical trials, preclinical research, and drug discovery. This report helps executives track competitors pipeline molecules. The information presented in this report can be used for identifying partners, evaluating opportunities, formulating business development strategies, executing in-licensing and out-licensing deals. The report provides information on pipeline molecules by company and mechanism of action across the R&D stages. It also provides information on pipeline molecules developed in leading geographies (North America and Europe). Licensing activities are thoroughly captured in this report. Key Features of the Report: - Erectile Dysfunction: Overview - Erectile Dysfunction Pipeline Overview - Erectile Dysfunction Phase 3 Clinical Trial Pipeline Insights - Erectile Dysfunction Phase 2 Clinical Trial Pipeline Insights Read more: Research and Markets: Global Erectile Dysfunction Drug Pipeline Capsule - 2012 Update … Continue reading →

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Mayo Clinic finds way to weed out problem stem cells, making therapy safer

Posted: Published on September 28th, 2012

Public release date: 27-Sep-2012 [ | E-mail | Share ] Contact: Jennifer Schutz newsbureau@mayo.edu 507-284-5005 Mayo Clinic ROCHESTER, Minn. -- Mayo Clinic researchers have found a way to detect and eliminate potentially troublemaking stem cells to make stem cell therapy safer. Induced Pluripotent Stem cells, also known as iPS cells, are bioengineered from adult tissues to have properties of embryonic stem cells, which have the unlimited capacity to differentiate and grow into any desired types of cells, such as skin, brain, lung and heart cells. However, during the differentiation process, some residual pluripotent or embryonic-like cells may remain and cause them to grow into tumors. "Pluripotent stem cells show great promise in the field of regenerative medicine; however, the risk of uncontrolled cell growth will continue to prevent their use as a therapeutic treatment," says Timothy Nelson, Ph.D., M.D., lead author on the study, which appears in the October issue of STEM CELLS Translational Medicine. Using mouse models, Mayo scientists overcame this drawback by pretreated stem cells with a chemotherapeutic agent that selectively damages the DNA of the stem cells, efficiently killing the tumor-forming cells. The contaminated cells died off, and the chemotherapy didn't affect the healthy cells, Dr. Nelson … Continue reading →

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Nuvilex’s Subsidiary, Austrianova Singapore, to Provide Confirmatory Findings From Additional Pancreatic Cancer Trial …

Posted: Published on September 28th, 2012

SILVER SPRING, Md., Sept. 27, 2012 (GLOBE NEWSWIRE) -- Nuvilex, Inc. (NVLX), an international biotechnology provider of cell and gene therapy solutions, announced today that Austrianova Singapore Pte Ltd (ASPL) will reveal confirmatory findings from a second phase 2 pancreatic cancer clinical trial that used the encapsulated cytochrome P450 expressing cells followed by chemotherapy to treat pancreatic cancer at the International Society for Cell and Gene Therapy (ISCGT) meeting next week. ASPL's Chief Operating Officer, Dr John Dangerfield, will be presenting the clinical data at the upcoming ISCGT meeting in Singapore, October 4-7. The ISCGT has previously organized numerous meetings in the US, England, France, Germany, Italy, Ireland, China, India and Egypt. The ISCGT works in close collaboration with national societies and organizations, as well as local clinicians, to promote cell and gene therapies for use in cancer therapy advancement and treatment. Council members of the ISCGT include leading experts and peers that have made major contributions to advance cell and gene therapies. Dr. Brian Salmons, CEO of ASPL stated, "We determined that the ISCGT would be an important forum for presenting this additional data. The value for bringing this to ISCGT is a result of how they have been … Continue reading →

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Nuvilex's Subsidiary, Austrianova Singapore, to Provide Confirmatory Findings From Additional Pancreatic Cancer Trial …

Posted: Published on September 28th, 2012

SILVER SPRING, Md., Sept. 27, 2012 (GLOBE NEWSWIRE) -- Nuvilex, Inc. (NVLX), an international biotechnology provider of cell and gene therapy solutions, announced today that Austrianova Singapore Pte Ltd (ASPL) will reveal confirmatory findings from a second phase 2 pancreatic cancer clinical trial that used the encapsulated cytochrome P450 expressing cells followed by chemotherapy to treat pancreatic cancer at the International Society for Cell and Gene Therapy (ISCGT) meeting next week. ASPL's Chief Operating Officer, Dr John Dangerfield, will be presenting the clinical data at the upcoming ISCGT meeting in Singapore, October 4-7. The ISCGT has previously organized numerous meetings in the US, England, France, Germany, Italy, Ireland, China, India and Egypt. The ISCGT works in close collaboration with national societies and organizations, as well as local clinicians, to promote cell and gene therapies for use in cancer therapy advancement and treatment. Council members of the ISCGT include leading experts and peers that have made major contributions to advance cell and gene therapies. Dr. Brian Salmons, CEO of ASPL stated, "We determined that the ISCGT would be an important forum for presenting this additional data. The value for bringing this to ISCGT is a result of how they have been … Continue reading →

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Side effects of ADHD drugs shock parents

Posted: Published on September 28th, 2012

Kim Colliers 7-year-old daughter could not stop crying. Less than 24 hours earlier, the child had started taking Vyvanse, a drug prescribed for the treatment of ADHD. The distraught mother suggested a bike ride to distract the inconsolable child. The two set out for a park near their home outside Alliston, Ont. The girl pedalled and sobbed. Then, Collier recalled, She screamed at me. She said, I want to die. A car drove toward them along the residential street. She looked at me and she said, Im going to ride my bike into that car. And then she said to me, You dont care if I live or die. I literally had to restrain her. I took her off of the drug. Collier, who did not want her daughter named, is one of scores of parents who contacted the Star after its investigation Wednesday found nearly 600 cases of Canadian kids suffering serious, sometimes fatal side effects suspected to have been caused by ADHD medications in the past 10 years. Read the original here: Side effects of ADHD drugs shock parents … Continue reading →

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M.E. Swing takes over Gold Crust space in Alexandria

Posted: Published on September 28th, 2012

The historic M.E. Swing will open a coffee bar and roasting facility in the former Gold Crust Baking building in Alexandria. (Mark Warmuth/M.E. Swing Coffee Roasters) M.E. Swing Coffee Roasters current facility in a bleak industrial section of Alexandria has been an increasing source of irritation for owner Mark Warmuth. The isolation from potential drive-by customers. The influx of auto body shops. The lack of parking. Hes been looking to flee the space for years now, almost since he bought the historic Swings in 2006. But it wasnt until this year that he found the right spot: the former Gold Crust Baking building at 501 E. Monroe Ave., in Alexandria. Warmuth signed a lease this summer. The 9,600-square-foot space has almost everything Warmuth wants: more space for a coffee bar and a training/cupping lab, but also access to potential residential customers. A YMCA, a park, a grocery store and a pharmacy are all in the same general area, attracting scores of neighbors. Warmuth hopes to entice a few his way with the smell of freshly roasting coffee beans (although parking may still present a problem, because there arent many spaces at the new spot, either). Once we build it, theres … Continue reading →

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