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 →

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 →

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 →

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 →