Osiris Therapeutics announced a couple of legal and regulatory victories this week. The Columbia biotech, which develops stem cell treatments for a variety of conditions, won a challenge to its Australian patent. The patent, filed in 2009, covers the use of mesenchymal stem cells, including the companys intravenous Prochymal product, to treat inflammatory conditions in the gastrointestinal tract, including Crohns disease and ulcerative colitis. Under Australian law, the opponents identity was not disclosed, Osiris said in a news release. Actually, the challenge was filed in November by a patent attorney, Gavin Recchia. But under Australian law, such challenges may be filed by anyone, including those without a commercial interest, Victor Portelli of the Australian patent agency said. However, the client of the filer need not be disclosed, at least initially. The challenge was withdrawn this month before any supporting evidence was filed. Last year, Prochymal became the worlds first stem cell drug approved by an internationally recognized regulatory authority. Its also approved to treat acute graft versus host disease, a serious complication of bone marrow transplantation that kills up to 80 percent of children affected, many soon after diagnosis, according to Osiris. Canada and New Zealand have approved it, and … Continue reading →

Feb. 21, 2013 Cell therapy is a promising alternative to tissue and organ transplantation for diseases that are caused by death or poor functioning of cells. Considering the ethical discussions surrounding human embryonic stem cells, a lot is expected of the so-called 'induced pluripotent stem cells' (iPS cells). However, before this technique can be applied effectively, a lot of research is required into the safety and efficacy of such iPS cells. VIB scientists associated to the UGent have developed a mouse model that can advance this research to the next step. Lieven Haenebalcke (VIB/UGent): "iPS cells have enormous therapeutic potential, but require more thorough testing before they can be used for such purposes. Using our new mouse model, we can study which mechanisms determine the identity of a cell. This knowledge is essential before we can use cell therapy for regenerative medicine." Jody Haigh (VIB/UGent): "If we want to give cell therapy a future, then we must continue this type of research and invest in the further development of such technologies. This will result in an improved insight into cellular identity and -- in the long term -- safer options of applying iPS cells or cells derived from iPS cells … Continue reading →

NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (PFE) today announced top-line results for a Phase 3 study that showed Lyrica (pregabalin) Capsules CV were as effective as levetiracetam as an adjunctive therapy in adult epilepsy patients experiencing refractory partial onset seizures. The top-line results indicate that the study met its primary endpoint by demonstrating that a comparable proportion of patients on Lyrica achieved at least a 50 percent reduction in the 28-day seizure rate during the maintenance phase relative to levetiracetam. The adverse event profile in the study was consistent with that known for Lyrica. Epilepsy is a chronic disorder in which seizures occur intermittently. Partial onset seizures (simple, complex, and secondarily generalized tonic-clonic) are the most common, particularly in adults, and often require more than one antiepileptic medication. Patients with refractory partial onset seizures are those patients whose seizures are not completely controlled by medical treatment. About the Study The study was a randomized, double-blind, parallel-group, multicenter, comparative, flexible-dose study to compare Lyrica (300, 450, 600 mg/day) to levetiracetam (1,000, 2,000, 3,000 mg/day) in reducing partial onset seizure frequency in subjects with epilepsy. Subjects included in the study were diagnosed with epilepsy with partial onset seizures for at least two years, … Continue reading →