Pluristem Issues Letter to Shareholders Highlighting Significant Achievements on Several Fronts
Increasing Cash Position to About $70 Million, Targeting Future Clinical Trials in Bone Marrow Transplant Failure Indications, Progress in Clinical Trials, New Regulatory Approvals & New Manufacturing Facilities to Service Markets HAIFA, Israel, Oct 9, 2012 (GlobeNewswire via COMTEX) -- Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapies, today announced that the Company has issued a letter to shareholders that provides an overview of the numerous milestones recently achieved by the company. The letter can be found on the company's website. Highlights include:
-- Raised net $34 million in a secondary offering, bringing the company's cash position to approximately $70 million, with no debt
-- Targeting future clinical trials in Bone Marrow Transplant failure indications, following the improvement of clinical condition and hematological counts after treatment of critically ill patients under a compassionate use program at the Hadassah Medical Center in Jerusalem
-- Began FDA-approved Phase II clinical trials in the U.S. for Intermittent Claudication
-- Received approval for Phase I/II clinical trial in muscle injury in Germany
-- Received approval from the Indian Ministry of Health to begin Phase II clinical trials in Buerger's Disease patients
-- Filed for Orphan Drug Status with the U.S. FDA for Aplastic Anemia
-- Optimizing manufacturing processes for commercial scale up
-- Building a new state-of-the-art manufacturing GMP facility in Israel suitable for large-scale production.
-- Pursuing new indications and fields of research in lung disease and acute radiation syndrome
To read Pluristem's Letter to Shareholders in full, please visit: pluristem.com About Pluristem Therapeutics
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PLTR) is a leading developer of placenta-based cell therapies. The Company's patented PLX (PLacental eXpanded) cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are grown using the company's proprietary 3D micro-environmental technology and are an "off-the-shelf" product that requires no tissue matching prior to administration. Pluristem is focusing on the development of PLX cells administered locally to potentially treat systemic diseases and potentially obviating the need to use the intravenous route.
Data from two phase I studies indicate that Pluristem's first PLX product candidate, PLX-PAD, is safe and potentially effective for the treatment of end stage peripheral artery disease when given locally. Additionally, Pluristem is developing PLX-PAD for cardiac ischemia, PLX-BMP for Acute Radiation Exposure, Bone Marrow Transplant Failure and Chemotherapy induced Bone Marrow Aplasia, PLX-ORTHO for orthopedic indications and PLX-PAH for Pulmonary Hypertension in collaboration with United Therapeutics. Pluristem's pre-clinical animal models have demonstrated PLX cells are also potentially effective in other inflammatory/ischemic indications, including diastolic heart failure, inflammatory bowel disease, neuropathic pain and pulmonary fibrosis.
Pluristem has a strong patent portfolio, company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release. Follow Pluristem on Twitter@Pluristem. |