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Bio-Matrix Subsidiary "First in Class" Approach to Stem Cell Medicine

Posted: Published on May 4th, 2012

SAN DIEGO, CA--(Marketwire -05/03/12)- Regen BioPharma (Regen), Inc. a newly-formed subsidiary of Bio-Matrix Scientific Group, Inc. (BMSN.PK - News) (BMSN.PK - News), unveiled today its operational plan for its "Super-Incubator" stem cell company. Month 1-2: Assembly of Team. Regen intends to assemble a team of world-class leaders in the spheres of Technology, Intellectual Property assessment, valuation and Clinical development. Regen will seek to compile a team of Physician-Scientists with experience in the area of clinical trials for regenerative medicine/stem cell products, Regulatory experts who have successfully taken products through the FDA and corresponding agencies internationally, and Biotech Entrepreneurs who have track records of excellence in business formation and value optimization. Month 1-4: In-licensing of Intellectual Property. The Company having already assessed over 20,000 issued patents and having compiled a shortlist of 30 targets; Regen will seek to execute licensing deals on an initial core of 3 technologies. Regen focuses on issued patents that have already passed preclinical studies but are not under clinical development. Month 3-6: Interaction with Regulatory Agencies. Regen intends to develop data packages for each of the technologies and initiate interaction with Regulatory Agencies such as the FDA for initiation of trials. Month 6-18: Clinical Implementation. Regen … Continue reading

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Genetically Modified T Cell Therapy Shown to be Safe, Lasting in Decade-Long Penn Medicine Study of HIV Patients

Posted: Published on May 4th, 2012

PHILADELPHIA HIV patients treated with genetically modified T cells remain healthy up to 11 years after initial therapy, researchers from the Perelman School of Medicine at the University of Pennsylvania report in the new issue of Science Translational Medicine. The results provide a framework for the use of this type of gene therapy as a powerful weapon in the treatment of HIV, cancer, and a wide variety of other diseases. "We have 43 patients and they are all healthy," says senior author Carl June, MD, a professor of Pathology and Laboratory Medicine at Penn Medicine. "And out of those, 41 patients show long term persistence of the modified T cells in their bodies." Early gene therapy studies raised concern that gene transfer to cells via retroviruses might lead to leukemia in a substantial proportion of patients, due to mutations that may arise in genes when new DNA is inserted. The new long-term data, however, allay that concern in T cells, further buoying the hope generated by work June's team published in 2011 showing the eradication of tumors in patients with chronic lymphocytic leukemia using a similar strategy. "If you have a safe way to modify cells in patients with HIV, … Continue reading

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Genetically modified T cell therapy appears to be safe, lasting in decade-long study of HIV patients

Posted: Published on May 4th, 2012

ScienceDaily (May 2, 2012) HIV patients treated with genetically modified T cells remain healthy up to 11 years after initial therapy, researchers from the Perelman School of Medicine at the University of Pennsylvania report in the new issue of Science Translational Medicine. The results provide a framework for the use of this type of gene therapy as a powerful weapon in the treatment of HIV, cancer, and a wide variety of other diseases. "We have 43 patients and they are all healthy," says senior author Carl June, MD, a professor of Pathology and Laboratory Medicine at Penn Medicine. "And out of those, 41 patients show long term persistence of the modified T cells in their bodies." Early gene therapy studies raised concern that gene transfer to cells via retroviruses might lead to leukemia in a substantial proportion of patients, due to mutations that may arise in genes when new DNA is inserted. The new long-term data, however, allay that concern in T cells, further buoying the hope generated by work June's team published in 2011 showing the eradication of tumors in patients with chronic lymphocytic leukemia using a similar strategy. "If you have a safe way to modify cells in … Continue reading

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Genetically modified T cell therapy shown to be safe, lasting in decade-long study of HIV patients

Posted: Published on May 4th, 2012

Public release date: 2-May-2012 [ | E-mail | Share ] Contact: Holly Auer holly.auer@uphs.upenn.edu 215-200-2313 University of Pennsylvania School of Medicine PHILADELPHIA -- HIV patients treated with genetically modified T cells remain healthy up to 11 years after initial therapy, researchers from the Perelman School of Medicine at the University of Pennsylvania report in the new issue of Science Translational Medicine. The results provide a framework for the use of this type of gene therapy as a powerful weapon in the treatment of HIV, cancer, and a wide variety of other diseases. "We have 43 patients and they are all healthy," says senior author Carl June, MD, a professor of Pathology and Laboratory Medicine at Penn Medicine. "And out of those, 41 patients show long term persistence of the modified T cells in their bodies." Early gene therapy studies raised concern that gene transfer to cells via retroviruses might lead to leukemia in a substantial proportion of patients, due to mutations that may arise in genes when new DNA is inserted. The new long-term data, however, allay that concern in T cells, further buoying the hope generated by work June's team published in 2011 showing the eradication of tumors in … Continue reading

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Stem cell therapy shows promise in fight against HIV

Posted: Published on May 4th, 2012

ScienceDaily (May 2, 2012) UC Davis Health System researchers are a step closer to launching human clinical trials involving the use of an innovative stem cell therapy to fight the virus that causes AIDS. In a paper published in the May issue of the Journal of Virology, the UC Davis HIV team demonstrated both the safety and efficacy of transplanting anti-HIV stem cells into mice that represent models of infected patients. The technique, which involves replacing the immune system with stem cells engineered with a triple combination of HIV-resistant genes, proved capable of replicating a normally functioning human immune system by protecting and expanding HIV-resistant immune cells. The cells thrived and self-renewed even when challenged with an HIV viral load. "We envision this as a potential functional cure for patients infected with HIV, giving them the ability to maintain a normal immune system through genetic resistance," said lead author Joseph Anderson, an assistant adjunct professor of internal medicine and a stem cell researcher at the UC Davis Institute for Regenerative Cures. "Ideally, it would be a one-time treatment through which stem cells express HIV-resistant genes, which in turn generate an entire HIV-resistant immune system." To establish immunity in mice whose … Continue reading

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Cryo-Cell International Taps Leader in Stem Cell Therapy to Serve as Chief Scientific Officer

Posted: Published on May 4th, 2012

OLDSMAR, Fla., May 3, 2012 (GLOBE NEWSWIRE) -- via PRWEB - Cryo-Cell International, Inc. announced the appointment of Linda Kelley, Ph.D., as chief scientific officer. Dr. Kelley is responsible for overseeing Cryo-Cells state-of-the art laboratory, translational medicine initiatives and quality assurance program at its stem cell and cord blood banking facility in Oldsmar, Florida. She joins the company from the Dana Farber Cancer Institute at Harvard, where she was the director of the Connell OReilly Cell Manipulation Core Facility. Dr. Kelley is an internationally recognized, cord blood stem cell scientist whose accomplishments have helped expand the scope of stem cell therapies from bone marrow transplantation to the treatment of heart, kidney, brain and other degenerative diseases. She was a member of the board of trustees of the Foundation for Accreditation of Cellular Therapy and chaired its Standards Committee. Dr. Kelley was one of 12 scientists selected by the Institute of Medicine of the National Academies of Science to serve on the panel that advised Congress on how to allocate $80 million in funding to optimally structure a national cord blood stem cell program. While director of the Cell Therapy Facility at the University of Utah, she established that states first … Continue reading

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Watchdog Says FDA Needs Drug Safety Tracking Database

Posted: Published on May 4th, 2012

A leading public health advocacy group has suggested the Food and Drug Administration (FDA) approve a comprehensive system for tracking adverse reactions and dangerous side effects of prescription drugs once they reach the U.S. market. According to a HealthDay News report on a new study from the Institute of Medicine, the group recognizes that a public clearinghouse for easily accessible information on the potential dangers of prescription drugs does not exist. In some countries, the public and physicians have access to a database which tracks reported side effects and adverse reactions to drugs. Domestically, patients are left to rely upon the recommendations of their physicians or through their own research from a variety of sources. Physicians rely on information they glean from medical journal reports and from colleagues as well as representatives of drug companies for the latest information on potentially dangerous drugs. In its study, Institute of Medicine suggested the FDA work to create a publicly-accessible database tracking these reports concerning prescription drugs. The database should, according to the report, contain a risk- and benefit-assessment plan for each drug and that information should include data from the time the drug reaches the market until the time it is removed. … Continue reading

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FDA staff question studies for Regeneron gout drug

Posted: Published on May 4th, 2012

Staff walk among the new buildings at the the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland, November 5, 2009. Credit: Reuters/Jason Reed WASHINGTON | Fri May 4, 2012 1:52pm BST WASHINGTON (Reuters) - U.S. drug reviewers said Regeneron Pharmaceuticals Inc's drug to prevent gout flares worked, but questioned its side effects and whether it did enough to help patients. The Food and Drug Administration staff on Friday said the injectable drug, called Arcalyst, was meant to be used for only 16 weeks to prevent gout flares - the first treatment for the condition with such a limited timeline. The FDA staff review comes ahead of an advisory panel of outside experts, which will vote on whether to recommend the drug next Tuesday. The FDA will make a final decision by July 30, taking into account the panel's recommendations. Regeneron's drug, known generically as rilonacept, is already approved to treat a group of rare genetic auto-inflammatory diseases. But the company is hoping to expand its use to prevent gout flares in people starting uric acid-lowering therapy. Gout is a painful condition that occurs when the bodily waste product, uric acid, is deposited in the joints and soft … Continue reading

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Company owner caught stealing from customers

Posted: Published on May 4th, 2012

The owner of a local pharmaceutical distribution company who was arrested two years ago for stealing from her customers has been arrested a second time, said Caddo Sheriff Steve Prator. Janice Lawrence, 62, of the 9000 block of Belmore Court, was booked into the Caddo Correctional Center on four counts of felony theft. Caddo Sheriffs Detective Bobby Herring said Lawrence, the owner of now-defunct USA Wholesale, recently completed a diversion program after being arrested in 2010 for similar crimes. While in diversion, detectives learned of several more pharmacies that had been defrauded by Lawrence between 2009 and 2010. Lawrence used bank information belonging to her customers to make unauthorized charges that profited her business. Her most recent arrest was for charging a total of $11,622 to the credit cards of four pharmacies for products that were never ordered or delivered. Those pharmacies were Turnage Drug Store in Mississippi, Lancaster Pharmacy in South Carolina, Adcocks Medicine Chest in Texas, and Whites Pharmacy in Alaska. Copyright 2012 KTBS. All rights reserved. This material may not be published, broadcast, rewritten or redistributed. Excerpt from: Company owner caught stealing from customers … Continue reading

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Drug price disparity: Where to buy?

Posted: Published on May 4th, 2012

INDIANAPOLIS (WISH) - You shop for the best price on gas and on your home. What about your prescription drugs? Most don't because they believe generic drugs mean cheaper or that you only have to pay your standard co-pay with your insurance, right? Wrong. An I-Team 8 investigation is uncovering what big drug companies and some pharmacies don't want you to know. Amy Peak is a pharmacist and director of Drug Information Services and Academic Advising. She says even on the generics there is such a "huge, huge" difference on pricing. So huge, I-Team 8 launched an investigation to uncover a rare behind the scenes look inside the drug pricing of a multi-billion dollar industry. "Just because you are getting generic doesn't mean you are getting a good deal, Peak says. I-Team 8 compared drug prices by calling different pharmacies but also through the Red Book, the source known only to insiders of wholesale prices. Drugs are distributed through wholesalers to pharmacies, and then to you. For example, the generic version of Lamisil, used for toe fungus and often not covered by insurance, has a cost difference that was alarming. Big differences between the same drug at different pharmacies. One … Continue reading

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