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TiGenix Completes Patient Enrollment in Phase IIa Rheumatoid Arthritis Study

Posted: Published on August 8th, 2012

LEUVEN, BELGIUM and MADRID, SPAIN--(Marketwire -08/08/12)- TiGenix (EURONEXT:TIG), the European leader in cell therapy, announced today the completion of patient enrollment in the Company's Phase IIa study of Cx611, a suspension of expanded allogeneic adult stem cells, in rheumatoid arthritis. The Phase IIa clinical trial is a 53-subject, multicenter, placebo-controlled study in 3 cohorts with different dosing regimens, designed to assess safety, feasibility, tolerance, and optimal dosing. The study is being conducted at 23 centers. The Company believes that this clinical trial can set the stage not only for the further development of Cx611 in RA, but also in a wide range of other autoimmune disorders. "In addition to the primary endpoints of safety and optimal dosing, we expect this trial to yield a first indication of the duration of the efficacy of Cx611 in this very difficult patient population: the enrolled patients have previously failed to respond to at least two biologicals," said Eduardo Bravo, CEO of TiGenix. "In the trial patients are treated with three injections of Cx611. The six-month follow-up without further dosing should provide us with a truly meaningful result. This is the most advanced stem cell therapy trial in RA in the world, and completing … Continue reading

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Research: High Testosterone Increases Prostate Cancer Risk

Posted: Published on August 8th, 2012

NEW YORK, Aug. 7, 2012 /PRNewswire/ --New research finds older men with higher levels of free testosterone have an increased risk of prostate cancer. Australian researchers spent a decade exploring the testosterone-prostate cancer connection by comparing natural testosterone levels of men in their 70s and 80s, those with prostate cancer and without. (Photo: http://photos.prnewswire.com/prnh/20120807/NY53583 ) "Men with late-onset prostate cancer had higher levels of testosterone," said Mount Sinai prostate cancer robotic surgeon, Dr. David Samadi. "The increased risk was seen in men with naturally high testosterone levels, as well as those taking testosterone hormone replacement therapy." The knowledge of testosterone's role in prostate cancer is not new. Hormone therapy, or androgen deprivation therapy, is a widely used prostate cancer treatment option designed to slow the growth of the disease by suppressing testosterone. This study was initiated to learn more about how testosterone might trigger the onset of prostate cancer. As part of The Health in Men Study (HIMS), researchers from The University of Western Australia discovered that men diagnosed with late-onset prostate cancer had testosterone levels that were 13 picomoles per liter of blood higher than those who did not develop the disease. An even greater testosterone increase was seen … Continue reading

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Stem-cell pioneer banks on future therapies

Posted: Published on August 8th, 2012

Shinya Yamanaka aims to produce cell lines from fetal blood cells. M. Naka/Aflo/Newscom Progress toward stem-cell therapies has been frustratingly slow, delayed by research challenges, ethical and legal barriers and corporate jitters. Now, stem-cell pioneer Shinya Yamanaka of Kyoto University in Japan plans to jump-start the field by building up a bank of stem cells for therapeutic use. The bank would store dozens of lines of induced pluripotent stem (iPS) cells, putting Japan in an unfamiliar position: at the forefront of efforts to introduce a pioneering biomedical technology. A long-held dream of Yamanakas, the iPS Cell Stock project received a boost last month, when a Japanese health-ministry committee decided to allow the creation of cell lines from the thousands of samples of fetal umbilical-cord blood held around the country. Yamanakas plan to store the cells for use in medicine is a bold move, says George Daley, a stem-cell biologist at Harvard Medical School in Boston, Massachusetts. But some researchers question whether iPS cells are ready for the clinic. Yamanaka was the first researcher to show, in 2006, that mature mouse skin cells could be prodded into reverting to stem cells1 capable of forming all bodily tissues. The experiment, which he … Continue reading

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Foundation Medicine and Clovis Oncology Announce Diagnostic Collaboration

Posted: Published on August 8th, 2012

CAMBRIDGE, Mass. & BOULDER, Colo.--(BUSINESS WIRE)-- Foundation Medicine, Inc. and Clovis Oncology, Inc. (CLVS) announced today that they have entered into a diagnostic collaboration. The goal of the collaboration is to develop an in-vitro diagnostic (IVD) to identify biomarkers to select cancer patients most likely to respond to Clovis product candidate rucaparib, a poly (ADP-ribose) polymerase (PARP) inhibitor currently in Phase I/II clinical development. We are pleased to collaborate with Foundation Medicine, said Patrick J. Mahaffy, president and CEO of Clovis Oncology. This continues our commitment to developing targeted therapies with companion diagnostics to identify the patients most likely to benefit from our therapeutics. Foundation Medicines leadership in next generation sequencing and genomic analysis make them an ideal partner to work with us on our rucaparib program. Foundation Medicine and Clovis Oncology will analyze the genomic alterations found in tissue samples from patients to evaluate the feasibility of developing an IVD method to identify patients who have tumors more likely to respond to rucaparib. In particular, the goal of the collaboration is to identify the additional genetic mutations beyond those in germ-line and somatic BRCA that are associated with defective DNA repair and may define appropriate tumor targets for rucaparib. … Continue reading

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Pluristem wins permit for muscle regeneration trial

Posted: Published on August 8th, 2012

Pluristem Therapeutics Ltd. (Nasdaq:PSTI; DAX: PJT: PLTR) has received permission from Germany's Paul-Ehrlich-Institute (PEI), the country's medical regulatory agency, to commence a Phase I/II clinical trial to assess the safety and efficacy of its placental stem cell (PLX) therapy for the regeneration of injured gluteal musculature following total hip replacement. The PLX cells will be administered by intramuscular injections. The trial will include 18 patients scheduled to undergo a total hip replacement. Patients will receive either PLX cells or a placebo. Each patient will be monitored for 12 months. Pluristem said that muscle damage is a common result of hip replacement surgery, which is increasing in Europe and other developed nations as populations age. 150 per 100,000 people undergo hip replacement surgery in Europe a year, and procedures rose by one thid in 1998-2008. It estimates there are 300,000 total and partial hip replacements in the US each year. Pluristem chairman and CEO Zami Aberman said, "This is an important new indication for PLX cells, as beyond potentially showing safety and efficacy in muscle regeneration after hip replacement surgery, this opens PLX cells to the possibility of addressing large new markets in sports injury treatment and muscular regenerative medicine. We … Continue reading

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Stem-cell pioneer banks on future therapies

Posted: Published on August 7th, 2012

Shinya Yamanaka aims to produce cell lines from fetal blood cells. M. Naka/Aflo/Newscom Progress toward stem-cell therapies has been frustratingly slow, delayed by research challenges, ethical and legal barriers and corporate jitters. Now, stem-cell pioneer Shinya Yamanaka of Kyoto University in Japan plans to jump-start the field by building up a bank of stem cells for therapeutic use. The bank would store dozens of lines of induced pluripotent stem (iPS) cells, putting Japan in an unfamiliar position: at the forefront of efforts to introduce a pioneering biomedical technology. A long-held dream of Yamanakas, the iPS Cell Stock project received a boost last month, when a Japanese health-ministry committee decided to allow the creation of cell lines from the thousands of samples of fetal umbilical-cord blood held around the country. Yamanakas plan to store the cells for use in medicine is a bold move, says George Daley, a stem-cell biologist at Harvard Medical School in Boston, Massachusetts. But some researchers question whether iPS cells are ready for the clinic. Yamanaka was the first researcher to show, in 2006, that mature mouse skin cells could be prodded into reverting to stem cells1 capable of forming all bodily tissues. The experiment, which he … Continue reading

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GW Researcher finds depressive symptoms and suicidal thoughts in former finasteride users

Posted: Published on August 7th, 2012

Public release date: 7-Aug-2012 [ | E-mail | Share ] Contact: Lisa Anderson lisama2@gwu.edu 202-994-3121 George Washington University WASHINGTON (Aug 7, 2012) New research, to be published in the Journal of Clinical Psychiatry, finds that men who developed persistent sexual side effects while on finasteride (Propecia), a drug commonly used for male pattern hair loss, have a high prevalence of depressive symptoms and suicidal thoughts. The study, titled "Depressive Symptoms and Suicidal Thoughts Among Former Users of Finasteride With Persistent Sexual Side Effects," was authored by Michael S. Irwig, M.D., an assistant professor of medicine in the Division of Endocrinology at the George Washington University School of Medicine and Health Sciences. For the study, Dr. Irwig administered standardized interviews to 61 men who were former users of finasteride with persistent sexual side effects for more than three months. The interview gathered demographic information, medical and psychiatric histories, and information on medication use, sexual function, and alcohol consumption. All of the former finasteride users were otherwise healthy men with no baseline sexual dysfunction, medical conditions, psychiatric conditions or use of oral prescription medications. Dr. Irwig also conducted interviews with a control group of 29 men who had male pattern hair loss … Continue reading

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Depressive symptoms and suicidal thoughts found in former finasteride users

Posted: Published on August 7th, 2012

ScienceDaily (Aug. 7, 2012) New research, to be published in the Journal of Clinical Psychiatry, finds that men who developed persistent sexual side effects while on finasteride (Propecia), a drug commonly used for male pattern hair loss, have a high prevalence of depressive symptoms and suicidal thoughts. The study, titled "Depressive Symptoms and Suicidal Thoughts Among Former Users of Finasteride With Persistent Sexual Side Effects," was authored by Michael S. Irwig, M.D., an assistant professor of medicine in the Division of Endocrinology at the George Washington University School of Medicine and Health Sciences. For the study, Dr. Irwig administered standardized interviews to 61 men who were former users of finasteride with persistent sexual side effects for more than three months. The interview gathered demographic information, medical and psychiatric histories, and information on medication use, sexual function, and alcohol consumption. All of the former finasteride users were otherwise healthy men with no baseline sexual dysfunction, medical conditions, psychiatric conditions or use of oral prescription medications. Dr. Irwig also conducted interviews with a control group of 29 men who had male pattern hair loss but who had never used finasteride and who denied any history of psychiatric conditions or use of psychiatric … Continue reading

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Lower risk of serious side-effects in trials of new targeted drugs

Posted: Published on August 7th, 2012

Public release date: 7-Aug-2012 [ | E-mail | Share ] Contact: ICR Science Communications Manager Jane Bunce jane.bunce@icr.ac.uk 44-207-153-5106 Institute of Cancer Research Patients in early clinical trials of new-style targeted cancer therapies appear to have a much lower risk of the most serious side-effects than with traditional chemotherapy, according to a new analysis. Researchers at The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust analysed data from 36 Phase I trials run by the organisations' joint Drug Development Unit. The study, published today in August's Annals of Oncology, found the overall risk to patients of suffering a life-threatening side-effect was around seven times less than for traditional cytotoxic agents*. Most new cancer drugs developed over recent years are targeted agents, which attack the specific genetic or molecular faults driving cancer growth, rather than one-size-fits-all chemotherapeutics, which kill all rapidly dividing cells. Recent studies have shown that patient response rates in Phase I trials of new-generation targeted drugs are approximately two-fold higher than for old-style drugs. But until now, the risk of side-effects to patients taking part in early stage trials of new-style drugs has been unclear. Senior author Dr Rhoda Molife, a medical oncologist and … Continue reading

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Oil hovers near $92 ahead of weekly US supply data

Posted: Published on August 7th, 2012

By PABLO GORONDI Associated Press The price of oil edged higher above $92 a barrel Tuesday as analysts estimated that supplies of U.S. crude and gasoline likely fell last week. By early afternoon in Europe, benchmark crude was up 33 cents at $92.56 a barrel in electronic trading on the New York Mercantile Exchange. The contract rose 80 cents on Monday to settle at $92.20 in New York. In London, Brent crude was up 92 cents at $110.47 on the ICE Futures exchange. The American Petroleum Institute is scheduled to announce its weekly crude and oil products supply data later Tuesday. Analysts surveyed by Platts, the energy information arm of McGraw-Hill Cos., predict crude inventories fell 300,000 barrels while gasoline stocks dropped 2 million barrels, signs that energy demand may be improving. The Energy Department's Energy Information Administration reports its weekly supply data - the market benchmark - on Wednesday. After jumping from below $78 in June, crude has hovered near $90 for the last few weeks as investors weigh weak global economic growth against possible monetary and fiscal stimulus measures. "We're stuck once again in a range," Carl Larry of Oil Outlooks and Opinions said in a report. "It … Continue reading

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