SCMOM 2012_Ensuring Maximum Reimbursement for a Regen Med Product
How to ensure that your regenerative medicine product is appropriately reimbursed is an increasingly difficult task for company executives. Thriving in both the private insurance and Medicare markets requires careful and long-range planning. Using a case-study approach, these panelists will discuss reimbursement challenges, goals, and strategies. They will discuss how to get products covered and reimbursed by payers in an environment that demands cost effectiveness and value.From:AllianceRegenMedViews:7 0ratingsTime:58:34More inScience Technology

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SCMOM 2012_The Regen Med Investment Hypothesis
This session will examine the regenerative medicine investment hypothesis from the perspective of the primary sources of capital at key stages in the development process from discovery to late-stage clinical development. Additionally, panelists will discuss different parts of the sector -- therapeutics, devices, tools, and services - and different types of business models to explore how they evaluate risk and why some models are more compelling than others. Investor perspectives represented on the panel will include traditional venture, angels, institutional investors and corporate strategics.From:AllianceRegenMedViews:3 0ratingsTime:56:18More inScience Technology

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Stem Cells 101 - Mayo Clinic
Stem cells and their use in regenerative medicine have been in the media a lot lately. But, what exactly does it mean? Physicians and researchers in the Center for Regenerative Medicine at Mayo Clinic say it has to do with developing completely new ways to treat and manage chronic diseases such as diabetes, heart failure or even degenerative nerve, bone and joint conditions. Experts worldwide will meet this December for the World Stem Cell Summit, where they #39;ll explore and share ideas about regenerative medicine. Here are the basics of how this research benefits patients.From:mayoclinicViews:654 8ratingsTime:02:20More inScience Technology

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Stem Cells for Regenerative Medicine
http://www.ucsf.edu Stem cell banks might one day be used to meet the tissue-transplant needs of most of the population. Just as there are universal blood donors, cells from universal donors could be used to develop induced pluripotent stem cells (iPS cells) or adult stem cells for use in repairing the nervous system, the heart or other organs. Off-the-shelf cell lines could be made available for recipients in a timely way, with matching likely to lower risk of transplant rejection. UCSF stem cell scientist Bruce Conklin, MD, discusses.From:UCSFPublicAffairsViews:20 1ratingsTime:03:29More inEducation

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Stem Cells and Insurance
The current state of the economy is uncertain and cause for concern for any business. Stem cell banks are no exception. When banks close down for any reason, its customers are immediately outraged about the money they have deposited. In the event of a stem cell bank failure, the investment is much more precious. These cells are of great interest in research because of their immense potential in regenerative medicine and other applications. A contingency plan needs to be implemented in order to protect these resources that are being used to find valuable treatments for otherwise incurable diseases.From:Alexandra KellyViews:2 0ratingsTime:02:53More inPeople Blogs

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Washington, November 28 (ANI): A new method, which transforms aged stem cells into cells that function like much younger ones, may one day enable scientists to grow cardiac patches for damaged or diseased hearts from a patient's own stem cells-no matter what age the patient-while avoiding the threat of rejection.

Stem cell therapies involving donated bone marrow stem cells run the risk of patient rejection in a portion of the population, argues Milica Radisic, Canada Research Chair in Functional Cardiovascular Tissue Engineering at the Institute of Biomaterials and Biomedical Engineering (IBBME) and Associate Professor in the Department of Chemical Engineering and Applied Chemistry at the University of Toronto.

One method of avoiding the risk of rejection has been to use cells derived from a patient's own body. But until now, clinical trials of this kind of therapy using elderly patients' own cells have not been a viable option, since aged cells tend not to function as well as cells from young patients.

Now, Radisic and her co-researcher, Dr. Ren-Ke Li, have come closer to solving this problem, by creating the conditions for a 'fountain of youth' reaction within a tissue culture.

Radisic and Li first create a "micro-environment" that allows heart tissue to grow, with stem cells donated from elderly patients at the Toronto General Hospital.

The cell cultures are then infused with a combination of growth factors-common factors that cause blood vessel growth and cell proliferation-positioned in such a way within the porous scaffolding that the cells are able to be stimulated by these factors.

Dr. Li and his team then tracked the molecular changes in the tissue patch cells.

"We saw certain aging factors turned off," states Li, citing the levels of two molecules in particular, p16 and RGN, which effectively turned back the clock in the cells, returning them to robust and healthy states.

"It's very exciting research," said Radisic, who was named one of the top innovators under 35 by MIT in 2008 and winner of the 2012 Young Engineers Canada award.

Li and Radisic hope to continue their goal to create the most effective environment in which cells from older patients can be given new life.

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'Fountain of youth' technique may help create heart patches from old cells

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Toronto, Nov 28 (IANS) A new discovery that tricks aging stem cells into rejuvenating mode could enable scientists to create youthful patches for damaged or diseased hearts and heal them, according to a Canadian study.

The breakthrough may enable scientists to create such life giving patches from a patient's own stem cells regardless of the patient's age while avoiding the threat of rejection, the study claims.

Stem cell therapies involving donated bone marrow stem cells run the risk of patient rejection in a portion of the population, argues Milica Radisic, associate professor of chemical engineering and applied chemistry at the University of Toronto, the Journal of the American College of Cardiology reports.

One method of avoiding such a risk has been to use cells derived from a patient's own body. But until now, clinical trials of this kind of therapy using elderly patients' own cells have not been a viable option, since aged cells tend not to function as well as cells from young patients, according to a Toronto statement.

"If you want to treat these people with their own cells, how do you do this?" asks Radisic. It's a problem that Radisic and coresearcher RenKe Li think they might have an answer for: by creating the conditions for a 'fountain of youth' reaction within a tissue culture. Li is a professor in the division of cardiovascular surgery.

Radisic and Li first create a "microenvironment" that allows heart tissue to grow, with stem cells donated from elderly patients at the Toronto General Hospital, where Li works.

Li and his team then tracked the molecular changes in the tissue patch cells. "We saw certain aging factors turned off," states Li, citing the levels of two molecules in particular, p16 and (regucalcin) RGN, which effectively turned back the clock in the cells, returning them to robust and states.

"It's very exciting research," says Radisic, who was named one of the top innovators under 35 by MIT in 2008 and winner of the 2012 Young Engineers Canada award.

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Stem cell discovery may revive damaged heart

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ScienceDaily (Nov. 27, 2012) A new method of growing cardiac tissue is teaching old stem cells new tricks. The discovery, which transforms aged stem cells into cells that function like much younger ones, may one day enable scientists to grow cardiac patches for damaged or diseased hearts from a patient's own stem cells -- no matter what age the patient -- while avoiding the threat of rejection.

Stem cell therapies involving donated bone marrow stem cells run the risk of patient rejection in a portion of the population, argues Milica Radisic, Canada Research Chair in Functional Cardiovascular Tissue Engineering at the Institute of Biomaterials and Biomedical Engineering (IBBME) and Associate Professor in the Department of Chemical Engineering and Applied Chemistry at the University of Toronto.

One method of avoiding the risk of rejection has been to use cells derived from a patient's own body. But until now, clinical trials of this kind of therapy using elderly patients' own cells have not been a viable option, since aged cells tend not to function as well as cells from young patients.

"If you want to treat these people with their own cells, how do you do this?"

It's a problem that Radisic and her co-researcher, Dr. Ren-Ke Li, think they might have an answer for: by creating the conditions for a 'fountain of youth' reaction within a tissue culture.

Li holds the Canada Research Chair in Cardiac Regeneration and is a Professor in the Division of Cardiovascular Surgery, cross-appointed to IBBME. He is also a Senior Scientist at the Toronto General Research Institute.

Radisic and Li first create a "micro-environment" that allows heart tissue to grow, with stem cells donated from elderly patients at the Toronto General Hospital.

The cell cultures are then infused with a combination of growth factors -- common factors that cause blood vessel growth and cell proliferation -- positioned in such a way within the porous scaffolding that the cells are able to be stimulated by these factors.

Dr. Li and his team then tracked the molecular changes in the tissue patch cells. "We saw certain aging factors turned off," states Li, citing the levels of two molecules in particular, p16 and RGN, which effectively turned back the clock in the cells, returning them to robust and healthy states.

"It's very exciting research," says Radisic, who was named one of the top innovators under 35 by MIT in 2008 and winner of the 2012 Young Engineers Canada award.

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'Fountain of youth' technique rejuvenates aging stem cells

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SCMOM 2012_NeoStem
NeoStem, Inc. is an emerging technology leader in the fast-developing cell therapy market. Its business strategy combines a state-of-the-art contract development and manufacturing subsidiary, Progenitor Cell Therapy, LLC, with a medically important cell therapy product development program. NeoStem #39;s most clinically advanced therapeutic, AMR-001, is being developed at its Amorcyte subsidiary, which is enrolling patients in a Phase 2 trial for preservation of heart function after a heart attack. Athelos Corporation, also a NeoStem subsidiary, is in early stage clinical exploration of a T-cell therapy for autoimmune conditions. Pre-clinical assets include our VSELTM Technology platform and our mesenchymal stem cell product candidate for regenerative medicine. http://www.neostem.com Presenter: Jonathan Sackner-Bernstein, NeoStem, Inc.From:AllianceRegenMedViews:4 1ratingsTime:14:54More inScience Technology

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SCMOM 2012_Stanford Cardiovascular Institute
Stanford Cardiovascular Institute (CVI) is the nucleus for cardiovascular research at Stanford University. Formed in 2004, the Cardiovascular Institute is home to Stanford #39;s myriad cardiovascular-related adult and pediatric research, clinical, and educational programs, centers and laboratories, as well as over 500 Stanford basic scientists, graduate students, clinician scientists, and other researchers in heart and vessel disease and prevention. Within the area of cardiac regenerative medicine, the Stanford CVI has significant research endeavors involving human pluripotent stem cells for (1) cardiovascular disease modeling, (2) drug screening and discovery, and (3) personalized cell therapy. Recently, Stanford CVI investigators received a $20 million CIRM Disease Team Therapy Award for performing pre-IND work that would enable the first-in-man clinical trial involving injection of human embryonic stem cell-derived cardiomyocytes for patients with heart failure. wulab.stanford.edu Presenter Joseph Wu, Associate Professor, Cardiovascular Medicine, Stanford University School of MedicineFrom:AllianceRegenMedViews:3 0ratingsTime:17:06More inScience Technology

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SCMOM 2012_Regen BioPharma, Inc.
The Regen BioPharma business model is to take multiple stem cell therapeutics to and through the human "safety and signal of efficacy" stage (Phase I/II clinical trials). The approach is a highly focused analysis of issued patents in regenerative medicine, identification and acquisition of undervalued assets that have demonstrated proof of concept, and forming companies around these assets. Having assembled a core infrastructure specialized in obtaining regulatory approval and executing clinical trials in cell therapy, we aim to act as a "superincubator" that within 18 - 24 months grows technologies from laboratory to an asset ready for spin-off or sale to feed the pipeline of Big Pharma. http://www.regenbiopharma.com Presenter: J. Christopher Mizer, President, Regen BioPharma, Inc.From:AllianceRegenMedViews:4 1ratingsTime:09:13More inScience Technology

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SCMOM 2012_TAP Biosystems
TAP Biosystems provides advanced automated systems for cell therapy scale-up and manufacture. At SCMOM 2012 TAP will be showcasing a range of systems including the CellBase CT trade; automated cell culture system for ex vivo expansion of autologous cell therapy products. Plus the Cellmate trade; system for batch production of cells in rollers bottles and the RAFT trade; system for producing biomimetic 3D tissue models in standard plate formats. Staff from TAP will also be available to discuss our collaborative working process to help businesses create new cell therapy scale-up and GMP manufacturing systems. http://www.tapbiosystems.com Presenter: Rosemary Drake, Chief Scientific Officer, TAP BiosystemsFrom:AllianceRegenMedViews:2 0ratingsTime:17:41More inScience Technology

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SCMOM 2012_The Clinical Outlook for Regenerative Medicine
As many regenerative medicine and cell therapy products move into clinical trials, a clearer understanding of how these products will perform clinically is critical for achieving regulatory approval and ultimately, for commercialization. This session will discuss the major clinical events expected to drive the regenerative medicine sector over the next two years, as well as address some of the key issues facing these products as they approach the marketplace. Moderator: Greg Lucier, MBA, Chairman and CEO, Life Technologies Panelists: Jay Siegel, MD, Chief Biotechnology Officer and Head, Global Pharmaceutical Regulatory Affairs, Janssen Pharmaceutical Companies of Johnson Johnson Paul Simmons, Ph.D., Executive Vice President, Corporate Research and Product Development, Mesoblast Limited Matthias Steger, Ph.D., MBA, Global Head Research and Technology Partnering, Roche Ltd. Dean Tozer, Vice President, Corporate Development, Shire Regenerative MedicineFrom:AllianceRegenMedViews:5 1ratingsTime:01:16:22More inScience Technology

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Ovation Cell Therapy- My First Impression!
Hey ya #39;ll. I realize that I am not wearing makeup in this video. If you find that to be frightening, please feel free to go watch something else 🙂 You know how I #39;m growing out my hair and stuff? Well, I stumbled upon Ovation Cell Therapy for like, super cheap, and thought I #39;d let you guys know what I think. I #39;ve read mixed reviews on the product and decided that I #39;d just have to try it for myself. I have naturally wavy, brown, medium-thick hair, just for anyone wondering! Here #39;s my first video on the topic. Hope you enjoy, and as always, thank you SO MUCH for watching :)From:Cristan JoViews:0 0ratingsTime:08:02More inHowto Style

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Public release date: 27-Nov-2012 [ | E-mail | Share ]

Contact: Robert Miranda cogcomm@aol.com Cell Transplantation Center of Excellence for Aging and Brain Repair

Putnam Valley, NY. (Nov. 27, 2012) A study published in the current issue of Cell Transplantation (21:8), now freely available on-line at http://www.ingentaconnect.com/content/cog/ct/, has found that when mesenchymal cells derived from skeletal muscle (SM-MSCs) or adipose tissue (ADSCs) were injected into the heart muscle (myocardium) of separate groups of laboratory rats that had suffered a myocardial infarction, rats in both groups experienced significantly improved left ventricle function and smaller infarct size after cell therapy.

The study, carried out by researchers at Oslo University Hospital and the Norwegian Center for Stem cell Research, Oslo University, sought to determine if MSCs from different organs would result in different functional outcomes.

"Despite advances in revascularization and medical therapy, acute myocardial infarction (AMI) and heart failure are still important causes of morbidity and mortality in industrialized countries," said study co-author Dr. Jan E. Brinchmann of the Norwegian center for Stem Cell Research at Oslo University Hospital, Oslo. "AMI leads to a permanent loss of contractile elements in the heart and the formation of fibrous scarring. Regeneration of contractile myocardium has been a target of cell therapy for more than a decade."

According to Dr. Brinchmann, MSCs tolerate hypoxia, secrete angiogenic factors and have been shown to improve vascularization; thus, they have properties suggesting that they may beneficially impact AMI, chronic heart failure and angina pectoris after cell transplantation. Following injection into the "border zone" and infarct area of immunodeficient rats one week after induced myocardial infarction, the researchers used echocardiography to measure myocardial function and other analyses to measure the size of scaring, density of blood vessels in the scar, and the health of myocardial tissues.

"Our results showed that intramyocardial injection of both ADSCs and SM-MSCs one week after AMI led to a substantial decrease in infarct size and a significant improvement in left ventricle function when compared with injections of cell culture medium alone," concluded the authors. "There was a trend toward better functional improvement in the SM-MSC group when compared to the ADSC group, but this did not reach significance."

They concluded that many questions remain unanswered, including the question of whether MSCs isolated from different organisms could result in different functional outcomes. Other unanswered questions relate to the optimal time delay between the onset of myocardial infarction and injection of MSCs. These cells do, however, still appear to be "a potentially interesting adjuvant treatment modality for selected patients following acute myocardial infarction," they concluded.

###

Contact: Dr. Jan E. Brinchmann, Norwegian Center for Stem Cell Research, Institute of Basic Medical Sciences, Oslo University Hospital Rikshospitalet and University of Oslo, PO Box 1121 Blindern 0317 Oslo, Norway. Tel. +42-22-84-04-89 Fax. +42-22- 85-10-58 Email: jan.brinchmann@rr.research.no

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Washington, November 28 (ANI): When mesenchymal cells derived from skeletal muscle (SM-MSCs) or adipose tissue (ADSCs) were injected into the heart muscle (myocardium) of separate groups of laboratory rats that had suffered a myocardial infarction, rats in both groups experienced significantly improved left ventricle function and smaller infarct size after cell therapy, a study has found.

The study, carried out by researchers at Oslo University Hospital and the Norwegian Center for Stem cell Research, Oslo University, sought to determine if MSCs from different organs would result in different functional outcomes.

"Despite advances in revascularization and medical therapy, acute myocardial infarction (AMI) and heart failure are still important causes of morbidity and mortality in industrialized countries," said study co-author Dr. Jan E. Brinchmann of the Norwegian center for Stem Cell Research at Oslo University Hospital, Oslo.

"AMI leads to a permanent loss of contractile elements in the heart and the formation of fibrous scarring. Regeneration of contractile myocardium has been a target of cell therapy for more than a decade," he added.

According to Dr. Brinchmann, MSCs tolerate hypoxia, secrete angiogenic factors and have been shown to improve vascularization; thus, they have properties suggesting that they may beneficially impact AMI, chronic heart failure and angina pectoris after cell transplantation.

Following injection into the "border zone" and infarct area of immunodeficient rats one week after induced myocardial infarction, the researchers used echocardiography to measure myocardial function and other analyses to measure the size of scaring, density of blood vessels in the scar, and the health of myocardial tissues.

"Our results showed that intramyocardial injection of both ADSCs and SM-MSCs one week after AMI led to a substantial decrease in infarct size and a significant improvement in left ventricle function when compared with injections of cell culture medium alone," concluded the researchers.

"There was a trend toward better functional improvement in the SM-MSC group when compared to the ADSC group, but this did not reach significance," they added.

They concluded that many questions remain unanswered, including the question of whether MSCs isolated from different organisms could result in different functional outcomes.

Other unanswered questions relate to the optimal time delay between the onset of myocardial infarction and injection of MSCs. These cells do, however, still appear to be "a potentially interesting adjuvant treatment modality for selected patients following acute myocardial infarction," they concluded.

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Different organ-derived stem cell injections improve heart function in rats

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A panel at the Harvard Law School Wednesday discussed the ethical debate over the use of embryonic stem cells in the United States, focusing on the burgeoning controversy surrounding the role of stem cell therapy in medical tourism.

Medical tourism, in which patients travel internationally to gain access to specific health care services, has become increasingly common, panelists said. They said that reasons for medical tourism range from basic hip replacement surgery to black market organ sales. As most stem cell therapies are not approved in the United States, numerous patients are going abroad to countries like China and Russia where treatment is legal.

Panelist I. Glenn Cohen, an assistant professor at the Law School, said that it was probable that a Chinese stem cell facility performs several hundred thousand of these treatments yearly. He said that numerous celebrities, including football quarterback Peyton Manning, have reportedly traveled abroad to receive stem cell treatment not approved by the FDA.

A number of facilities claim to use stem cells to cure a wide array of diseases. University of Alberta law professor Timothy Caulfield, another panelist, pointed out that a simple Google search leads potential patients to a plethora of websites which claim that diseases such as autism and cancer can be cured through stem cell therapy.

Its being offered as routine, its being offered as safe, its being offered as effective, Caulfield said, citing his own 2008 study on the subject, Of course, none of them being offered matched what the scientific literature said.

According to American history professor Jill Lepore, the hyper-acceleration of enthusiasm for stem cell therapy is reminiscent of a century ago when science journalism and government funding for science research began to blossom. Lepore pointed out how public excitement over scientific procedures has affected society in the past, popularizing cryonics research and the work of Eugene Steinach, who claimed his vasectomy operation reversed the aging process.

Panelists said that one issue with stem cell tourism is the number of health risks associated with such procedures, citing a number of instances where stem cell therapy caused serious harm.

They also noted that public discussion about stem cell therapy has been markedly positive, lending an air of legitimacy to stem cell therapy that hasnt been validated by research.

Articles criticizing stem cell tourism, on the other hand, have generally received a less favorable response. Caulfield told the audience that when he co-wrote an article in The Atlantic criticizing stem cell therapy, he was accused as being a nutball Canadian socialist bioethicist.

The panelists emphasized that more accurate information should be provided to the public regarding stem cell treatments.

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Professors Critique Stem Cell Medical Tourism

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ScienceDaily (Nov. 28, 2012) A new study by an international team of investigators led by Dana-Farber Cancer Institute scientists is the first to demonstrate that chemotherapy and a new, targeted therapy work better in combination than chemotherapy alone in treating patients with the most common genetic subtype of lung cancer.

Published online November 28 in The Lancet Oncology, the combination of chemotherapy and the targeted drug selumetinib was more effective than chemotherapy alone in a clinical trial involving patients with a form of non-small cell lung cancer (NSCLC) that carries a mutation in the gene KRAS -- a variety that represents about 20 percent of all NSCLC cases. Previously, no targeted agent, either alone or in combination with another drug, had proven beneficial in a trial involving patients with this type of NSCLC.

The 87 patients who participated in the new, phase II trial -- conducted at 67 sites around the world -- had advanced, KRAS-mutant NSCLC that had failed initial chemotherapy. The participants were randomly assigned to receive either selumetinib and the chemotherapy agent docetaxel or docetaxel alone.

Investigators found that while 37 percent of the patients in the selumetinib group experienced some shrinkage of their tumor, none of the patients in the docetaxel-only group did. Of particular significance, patients receiving selumetinib lived a median of 5.3 months before their cancer began to worsen, compared to 2.1 months for those receiving chemotherapy alone. (Patients in the selumetinib group also survived longer, on average, than those in the docetaxel group -- 9.4 months compared to 5.2 months -- but the improvement was not considered statistically significant.)

"Our findings suggest that selumetinib and docetaxel work synergistically -- each enhancing the effect of the other," says the study's lead author, Pasi A. Jnne, MD, PhD, of Dana-Farber. "This opens the possibility that there may finally be a therapeutic strategy using a targeted therapy which could be clinically effective in this population of KRAS-mutant lung cancer patients."

Some side effects, including neutropenia (a white blood cell deficiency), neuropenia plus fever, shortness of breath, and loss of strength, were more common in the selumetinib group than the other. Researchers and physicians will need to work on ways of managing these problems with patients, Jnne said.

NSCLC tumors with KRAS mutations are more common in current and former smokers than in those who have never smoked, and occur at a higher rate in Caucasians than in others. The study findings are especially noteworthy because mutated KRAS -- regardless of the type of tumor it appears in -- has been one of the most difficult genes to block with targeted therapies.

Selumetinib circumvents that problem by targeting not KRAS itself, but one of the gene's co-conspirators, a protein called MEK that is indirectly activated by KRAS.

"The opportunity now is to validate this approach in further clinical trials so it can be developed into a real therapy for patients," Jnne remarks. "Given that KRAS mutations are common in other cancers (found in 90 percent of pancreatic cancers and 40 percent of colon cancers), our findings may be useful in developing therapies for patients with these cancers as well."

The co-authors of the study are Alice Shaw, MD, of Massachusetts General Hospital; Jos Rodrigues Pereira, MD, of Instituto Brasileiro de Cancerologia Torcica, in Sao Paulo, Brazil; Galle Jeannin, MD, of Hpital Gabriel Montpied, in Clermont-Ferrand, France; Johan Vansteenkiste, MD, of University Hospital Gasthuisberg, in Leuven, Belgium; Carlos Barrios, MD, of PUCRS School of Medicine in Porto Alegre, Brazil; Fabio Andre Franke, MD, of Hospital de Caridade de Ijui, in Iju, Brazil; Victoria Zazulina, MD, Paul Smith, PhD, Ian Smith, MD, and Lynda Grinsted, of AstraZeneca UK, in Macclesfield, United Kingdom; and Lucio Crin, MD, of Hospital S Maria della Misericordia, in Perugia, Italy.

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First success of targeted therapy in most common genetic subtype of non-small cell lung cancer

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SILVER SPRING, Md. and SALZBURG, Austria, Nov. 28, 2012 (GLOBE NEWSWIRE) -- Nuvilex, Inc. (NVLX), an international biotechnology provider of cell and gene therapy solutions, announced today that its partner gave a presentation at the 40th Annual Conference of the Austrian Diabetes Society (ODG) based on the successful animal model studies for treating diabetes using the Company's proprietary cell encapsulation technology.

The three day event held in November at the Salzburg Congress Center in Salzburg, Austria, hosted an international group of researchers working on treatments for diabetes. Dr. Eva Brandtner, our partner who made the presentation at the meeting, is presently working at the Vorarlberg Institute for Vascular Investigation and Treatment (VIVIT) located in Feldkirch, Austria. She continues to maintain close ties to and is collaborating with Austrianova Singapore (ASPL) and Nuvilex to help advance the diabetes treatment. Dr. Brandtner, formerly Chief Scientist at ASPL before moving back to her native Austria, presented the study data on the use of pancreatic islet cells encapsulated using the Company's proprietary technology for the treatment of diabetes that was completed when she was working at ASPL.

Dr. Brian Salmons, CEO of ASPL said, "We are pleased Dr. Brandtner was invited to give a presentation at this prestigious event. She is a recognized expert in this field and we are very excited to be able to continue working together with Dr. Brandtner and VIVIT to develop new treatments for diabetes."

The Chief Executive of Nuvilex, Dr. Robert Ryan, stated: "Dr. Brandtner's presentation at this important diabetes event in Austria underscores our commitment to novel cell encapsulation based treatments for diabetes. The market potential for such a therapeutic is enormous, still growing dramatically worldwide, and we see the value for patients as priceless."

About Nuvilex

Nuvilex, Inc. (NVLX) is an international biotechnology provider of live therapeutically valuable, encapsulated cells and services for research and medicine. Important advances are moving Nuvilex and Austrianova Singapore forward. New developments by our companies will be substantial as we have been working on many fronts to move us forward. Our company's clinical offerings will include cancer, diabetes and other treatments using the company's cell and gene therapy expertise and live-cell encapsulation technology.

The Nuvilex, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=13494

Safe Harbor Statement

This press release contains forward-looking statements described within the 1995 Private Securities Litigation Reform Act involving risks and uncertainties including product demand, market competition, and meeting current or future plans which may cause actual results, events, and performances, expressed or implied, to vary and/or differ from those contemplated or predicted. Investors should study and understand all risks before making an investment decision. Readers are recommended not to place undue reliance on forward-looking statements or information. Nuvilex is not obliged to publicly release revisions to any forward-looking statement, reflect events or circumstances afterward, or disclose unanticipated occurrences, except as required under applicable laws.

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Nuvilex Continues Advancements in Diabetes Research

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PHILADELPHIA H. Lee Sweeney, Ph.D., the William Maul Measey Professor at the Perelman School of Medicine, University of Pennsylvania, has been named the inaugural director of Penns Center for Orphan Disease Research and Therapy. The primary mission of the Center is to expedite the translational science and development of novel therapies for rare and orphan diseases. The Center will achieve this by promoting innovative translational research and therapeutic strategies, building on partnerships among investigators, academic institutions, patients and advocacy groups, industry and funding agencies.

Formation of the new Center was catalyzed by a $10 million gift from an anonymous donor in July 2011. The Center fills a crucial need by providing the core laboratories, techniques, collaborative relationships, and expertise to lead an international, coordinated effort in the eradication of orphan diseases.

Diseases are classified as orphan, or rare, when they affect fewer than 200,000 people. However, as there are approximately 7,000 diseases now identified in this population, more than 25 million Americans are currently afflicted. Many of these diseases are caused by genetic mutations and are diagnosed in children. Research in many orphan diseases has lagged behind other major disease categories, such as diabetes and cardiovascular disease, in part because of a relative lack of technical expertise and funding mechanisms. Penn's Center will specifically address these needs.

I am pleased to name Dr. Sweeney as the first director of the Center for Orphan Disease Research and Therapy, says J. Larry Jameson, M.D., Ph.D., Executive Vice President for the Health System and Dean of the Perelman School of Medicine. The Center is a natural extension of Penn's expertise in the pathogenesis and treatment of rare diseases. With his decades of experience in basic biomedical research, work with families, and involvement with biotech firms and the federal government, Dr. Sweeney is an especially appropriate choice to lead the Center.

I feel that I have been preparing for this position for the past 15 years in my work with the neuromuscular disease community, says Sweeney. I look forward to expanding my experiences to a broader range of orphan diseases.

For much of his career, Sweeney, chair of the Department of Physiology until June 2013, a position he has held since 1999, has studied the mechanisms that help control muscle function with the hope of gaining a better understanding of ways to thwart muscle deterioration caused by age and degenerative diseases and to promote muscle growth. Sweeney has also directed the Paul D. Wellstone Muscular Dystrophy Cooperative Research Center at Penn since 2005.

Sweeneys research includes the study of animal models of Duchenne muscular dystrophy, a rapid muscle degenerative disease that can lead to muscle weakness, including the heart and diaphragm, ultimately limiting life expectancy. His research team at Penn studies both small molecule and gene therapy approaches to help treat genetic diseases and to validate possible therapeutic targets. He led a team of researchers who showed that a new drug called PTC124 could override a genetic mutation causing muscle degeneration in DMD mice without causing apparent side effects. PTC124, developed by PTC Therapeutics, a small biotech firm in NJ, in collaboration with Sweeneys lab, is currently in clinical trials with DMD and cystic fibrosis patients. For this body of work, Sweeney received a Hamdan Award for Medical Research Excellence from Sheikh Hamdan of Dubai in 2008.

He also serves as the Scientific Director of the Parent Project Muscular Dystrophy, an advocacy group whose mission is to end Duchenne muscular dystrophy and is actively involved in lobbying Congress for funding in the area of neuromuscular diseases.

The author of more than 180 papers and reviews that have more than 16,000 cumulative citations, Sweeney is a Fellow of the American Heart Association and a recipient of the Perelman Schools Stanley N. Cohen Biomedical Research Award. Sweeney has served on the advisory council of the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Currently, he is a member of the Committee on Neuromuscular Disease of the Association Franaise contre les Myopathies and of NIHs Skeletal Muscle and Exercise Physiology Study Section.

Sweeney is an alumnus of the Massachusetts Institute of Technology (S. B., Biology / Biochemistry). He earned both his A.M. degree in physiology and his doctorate in physiology and biophysics from Harvard University. After a year as a research instructor in physiology at the University of Texas Southwestern Medical School, he spent four years as assistant professor at the University of Texas at Austin. Dr. Sweeney joined the University of Pennsylvania in 1989 as assistant professor of Physiology. In 1998, he became professor of Physiology, with secondary appointments in Medicine (Division of Cardiology) and Surgery; in 2005, he added a secondary appointment in Pediatrics.

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Penn Scientist Named First Director of New Center for Orphan Disease Research and Therapy

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Gene, called Arih2, makes decides whether to switch on the immune response to an infection Researchers are looking at the effect on the immune response of switching gene off for short periods Say it has potential to help treat chronic conditions

By Daily Mail Reporter

PUBLISHED: 09:58 EST, 27 November 2012 | UPDATED: 10:50 EST, 27 November 2012

A newly discovered gene could hold the key to treating and potentially controlling chronic infections such as HIV, hepatitis and tuberculosis.

The gene, called Arih2, is essential for embryo survival. Now scientists have found it controls the function of the immune system making critical decisions about whether to switch on the immune response to an infection.

It could help in the development of treatments for infections that 'overwhelm' the immune system like HIV as well as conditions that cause chronic inflammation such as rheumatoid arthritis.

Dr Marc Pellegrini (left) and Dr Greg Ebert were part of a research team that discovered a gene which is essential to the immune response to infection

The gene was discovered in dendritic cells by a team from the Walter and Eliza Hall Institute in Australia. These cells act as an early warning system raising the alarm if they detect foreign invaders.

'Arih2 is responsible for the most fundamental and important decision that the immune system has to make - whether the immune response should be initiated and progressed or whether it should be switched off to avoid the development of chronic inflammation or autoimmunity,' research leader Dr Marc Pellegrini, said.

'If the wrong decision is made, the organism will either succumb to the infection, or succumb to autoimmunity.'

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Gene discovered that decides whether to 'switch on' immune system and could control HIV

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RESEARCH: Rebecca Grealy is studying influence of genes in skin cancer. Picture: Jerad Williams Source: The Courier-Mail

NEW research, set to be unveiled on the Gold Coast today, has revealed a person's genes contribute to the development and severity of non-melanoma skin cancer.

Griffith University PhD student Rebecca Grealy has led the five-year study that shows a person's genes can influence whether they get skin cancer and how susceptible they are to damage. Targeting these genes, researchers hope to develop a cream that could treat or cure skin cancer.

The findings go against previous warnings that the sun was solely to blame for a person developing skin cancer.

Griffith Health Institute director Lyn Griffiths, who is supervising Ms Grealy's research, said the cream would be developed on the Coast where skin damage was high.

"Queensland has the highest rates of skin cancer in the world," Ms Griffiths said.

"Non-melanoma is actually the most common, so there's a real need to try and work out the drivers behind people developing skin cancers. If we know there's certain genes that are playing a role, we can work out which genes (to target)."

Prof Griffiths said the cream would also overcome damage once people were diagnosed with it.

Ms Grealy is studying non-melanoma skin cancer - solar keratosis - that are not invasive cancers, but can develop into non-melanoma skin cancers.

In 2007, there were 448 deaths from non-melanoma skin cancer in Australia.

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Gene scan can detect cancer risk

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London, November 28 (ANI): A team of scientists from the Walter and Eliza Hall Institute in Australia has discovered a gene that could hold the key to treating and potentially controlling chronic infections such as HIV, hepatitis and tuberculosis.

They found that the gene, called Arih2, which is essential for embryo survival, also controls the function of the immune system - making critical decisions about whether to switch on the immune response to an infection, the Daily Mail reported.

The finding could help in the development of treatments for infections that 'overwhelm' the immune system like HIV as well as conditions that cause chronic inflammation such as rheumatoid arthritis, they said.

The team discovered the gene in dendritic cells, which act as an early warning system raising the alarm if they detect foreign invaders.

"Arih2 is responsible for the most fundamental and important decision that the immune system has to make - whether the immune response should be initiated and progressed or whether it should be switched off to avoid the development of chronic inflammation or autoimmunity," the paper quoted research leader Dr Marc Pellegrini as saying.

"If the wrong decision is made, the organism will either succumb to the infection, or succumb to autoimmunity," he added.

Dr Greg Ebert said Arih2 had significant promise as a drug target.

"Arih2 has a unique structure, which we believe make it an excellent target for a therapeutic drug, one that is unlikely to affect other proteins and cause unwanted side-effects," Dr Ebert said.

"Because Arih2 is critical for survival, we now need to look at the effect of switching off the gene for short periods of time, to see if there is a window of opportunity for promoting the immune response to clear the infection without unwanted or collateral damage or autoimmunity," he noted.

Though the researchers are very excited about their discovery, they noted that it would take many years to translate the discovery to a drug that could be used in humans. (ANI)

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Gene that could control HIV discovered

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Scientists have identified a gene which could help solve the problem of infertility in humans.

The team at the University of Edinburgh conducted a study with fruit flies, during which they found that when the gene SRPK is missing, chromosomes do not "huddle" together.

They believe the huddling process is necessary to ensure the egg's healthy development and fertilisation.

Chromosomes are thread-like structures which contain a person's DNA, and when they divide it can lead to sterility and low fertility, according to the study.

Previous research in mice has shown that the huddling process is essential in order for eggs to remain fertile, the scientists said.

By identifying the genes involved in the process, the experts now hope to gain an understanding of what goes on in the creation of fertile reproductive cells.

The team said further research is needed to help build a more detailed picture on how huddling works.

Professor Hiroyuki Ohkura, from the University of Edinburgh's School of Biological Sciences, said: "Fruit fly eggs serve as a good model to understand why sterility and low fertility arises in humans.

"By studying the phenomenon of chromosome clustering, shared by fruit flies and humans and identifying genes like SRPK we are gaining insights into fertility health."

The study is published in the Journal of Cell Science and was funded by the Wellcome Trust.

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'Huddle' gene linked to infertility

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ScienceDaily (Nov. 27, 2012) Some infants are more susceptible to potentially life-threatening breathing problems after birth, and rare, inherited DNA differences may explain why, according to research at Washington University School of Medicine in St. Louis.

The study is the first to identify a single gene -- ABCA3 -- that is associated with a significant number of cases of respiratory distress syndrome (RDS) in babies born at or near full term. RDS is the most common respiratory problem in newborns and the most common lung-related cause of death and disease among U.S. infants less than a year old.

Their findings will be published in the December 2012 issue of Pediatrics and are available online.

The research may lead to new diagnostic and therapeutic strategies for prevention and treatment to improve respiratory outcomes for babies.

"We found that mutations in ABCA3 account for about 10 percent of respiratory disease in babies born near their due dates," said Jennifer A. Wambach, MD, assistant professor of pediatrics and the study's lead author. "These are babies who we typically think should have mature lungs and breathe normally. While we have known for a while that RDS is a heritable disease, this is the first gene to account for a significant proportion of disease among infants that are full-term or nearly full-term."

RDS occurs when an infant's lungs don't produce enough surfactant, a liquid that coats the inside of the lungs and helps keep them open so the baby can breathe. If there isn't enough surfactant, an infant has to work hard to breathe and may suffer from a lack of oxygen. Premature infants are at especially high risk of RDS, as surfactant production increases as babies near term. However, 2 percent to 3 percent of term and near-term babies also develop RDS.

The researchers' findings suggest a range of possibilities, Wambach said. These include using the genetic knowledge to plan affected infants' births near hospitals with neonatal intensive-care units and developing medical therapies to target the abnormal protein resulting from these mutations.

Wambach said the researchers hope to identify additional genes that cause neonatal RDS and better identify babies at risk.

"But right now we're studying how these mutations function in the laboratory," Wambach said. "Statistical associations help guide us, but we also need to understand the biology of these mutations."

The research team -- including Aaron Hamvas, MD, and F. Sessions Cole, MD -- evaluated five genes known to be important for normal breathing immediately after birth. Hamvas is the James Keating Professor of Pediatrics and medical director of the newborn intensive care unit at St. Louis Children's Hospital. Cole is the Park J. White, MD, Professor of Pediatrics.

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Gene linked to respiratory distress in babies

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