Mesoblast Limited (ASX:MSB) today announced that it has received clearance from the United States Food and Drug Administration (FDA) to begin a Phase 2 clinical trial of its proprietary adult stem cells for the treatment of Type 2 diabetes.
Mesoblast's commercial strategy is based on its unique proprietary adult mesenchymal precursor cells.
The company's lead products will target cardiovascular conditions, diabetes, inflammatory conditions of lungs and joints, eye diseases, bone marrow cancers, bone fractures, cartilage degeneration and musculoskeletal conditions.
Mesoblast and global biopharmaceutical company Cephalon Inc. have established a strategic alliance to commercialize adult stem cell products for degenerative conditions of the cardiovascular and central nervous systems. The alliance also extends to products for augmenting bone marrow transplantation in cancer patients.
Mesoblast Limited (ASX:MSB) Chief Executive, Professor Silviu Itescu, today provided shareholders at Mesoblast's Annual General Meeting with an overview of the company's corporate strategy and major highlights of recent achievements.
Mesoblast Limited (ASX:MSB) Chairman's Address and CEO's Presentation to Shareholders
Positive Outcome From FDA Meeting For Type 2 Diabetes Clinical Program Using Intravenous Delivery of Mesoblast Limited (ASX:MSB) Proprietary Adult Stem Cells
Global regenerative medicine company, Mesoblast Limited (ASX:MSB), today announced that it has reached agreement with the United States Food and Drug Administration (FDA) on the key elements of the company's first clinical trial using intravenous delivery of its proprietary allogeneic, or off-the-shelf, mesenchymal precursor cell (MPC) technology in patients with Type 2 Diabetes. Based on the positive outcome of the FDA meeting held on November 18, Mesoblast will file an Investigational New Drug (IND) submission within the next 30-60 days to seek clearance for patient recruitment.
Mesoblast Limited (ASX:MSB) Presented Positive Results from Phase 2 Trial of Adult Stem Cell Therapy at the American Heart Association Annual Meeting
Regenerative medicine company Mesoblast Limited (ASX:MSB) today announced positive Phase 2 heart failure trial results of its allogeneic, or off-the-shelf, adult stem cell product Revascor(TM) after all patients had completed a minimum follow-up of 12 months, and a mean follow-up of 22 months. The Phase 2 trial results in 60 patients were presented at the American Heart Association annual meeting in Orlando, Florida, by the trial's independent principal investigator Dr Emerson C. Perin, Director of Research in Cardiovascular Medicine and Medical Director, Stem Cell Center, Texas Heart Institute in Houston.
Mesoblast Limited (ASX:MSB) Reports Positive Results Using Intravenously Injected Adult Stem Cells for Type 2 Diabetes
Regenerative medicine company, Mesoblast Limited (ASX:MSB), today announced that a single intravenous injection of its proprietary adult stem cells resulted in significant lowering of blood sugar levels for up to eight weeks in a controlled, randomized preclinical trial in non-human primates with Type 2 diabetes. This was accompanied by significant reductions in circulating inflammatory markers to levels associated with protection against heart attacks and death in patients with Type 2 diabetes. Results of the study were presented at the Credit Suisse Healthcare conference in Phoenix, Arizona.
Regenerative medicine company Mesoblast Limited (ASX:MSB) (PINK:MBLTY) today announced that it has received regulatory clearance from the Singapore Health Sciences Authority (HSA) to commence the first Phase 2 trial of its proprietary allogeneic (off-the-shelf) adult stem cell therapy for patients with proliferation of leaky blood vessels in the eyes - neovascular ("wet") Age-related Macular Degeneration (AMD). Wet AMD causes sudden and severe central vision loss and accounts for approximately 90 percent of all blindness in the elderly. Mesoblast is developing a stem cell therapeutic product for treating various vascular diseases of the eye, including wet AMD and diabetic macular edema (DME).
Mesoblast Limited (ASX:MSB) Received Licensing Executives Society 2011 Deals of Distinction(TM) Award
Mesoblast Limited (ASX:MSB) and its strategic alliance partner Cephalon Inc. were today awarded the Licensing Executives Society (U.S.A. and Canada), Inc. 2011 Deals of Distinction(TM) Award. The award was conferred for the most compelling licensing and intellectual property-related deal in the life sciences sector.
Global regenerative medicine company Mesoblast Limited (ASX:MSB) and Lonza Group (VTX:LONN), a world leader in biologic manufacturing, today announced that they have entered into a strategic alliance for clinical and long-term commercial production of Mesoblast's off-the-shelf (allogeneic) adult stem cell products.
Mesoblast Limited (ASX:MSB) Receives Clearance To Begin First European Trial Of Allogeneic Or 'Off-The-Shelf' Stem Cell Treatment For Heart Attacks
Global regenerative medicine company, Mesoblast Limited (ASX:MSB), today announced that it had received clearance from the European Medicines Agency (EMA) to begin a 225-patient multi-center Phase 2 clinical trial in Europe for its lead cardiovascular product Revascor(TM) in conjunction with angioplasty and stent procedures to prevent heart failure after a major heart attack. Revascor(TM) is an allogeneic, or "off-the-shelf", adult stem cell product derived from Mesoblast's proprietary Mesenchymal Precursor Cell (MPC) platform technology which is being developed for use in a range of cardiovascular diseases including congestive heart failure, chronic angina, and heart attacks.