Pluristem (Nasdaq:PSTI) 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 - October 9, 2012 (www.investorideas.com newswire) 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 here.
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.
CLICK HERE to watch a video where CLI patients and doctors involved with the clinical trials share their stories, the content of which is not part of this press release.
The Pluristem Therapeutics Inc. logo is available here
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, when we discuss possible future clinical trials in Bone Marrow Transplant failure indications, when we discuss that data from two phase I indicates that PLX-PAD is safe and potentially effective for the treatment of end stage peripheral artery disease, or when we discuss how pre-clinical animal models have demonstrated PLX cells are also potentially effective in other inflammatory/ischemic indications, we are using forward-looking statements. These forward-looking statements are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching our clinical trials; our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real surgical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.
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