Scottsdale, Arizona 3/4/2009 1:58:07 AM
News / Finance

Pluristem Therapeutics Inc. (PSTI) Granted FDA Clearance to Begin “First-In-Human” Placenta-Derived Stem Cell Clinical Trial

QualityStocks would like to highlight Pluristem Therapeutics Inc (NASDAQ: PSTI). Pluristem Therapeutics is a bio-therapeutics company dedicated to the commercialization of unrelated donor-patient (allogeneic) cell therapy products for the treatment of several severe degenerative, ischemic and autoimmune disorders. The Company is developing a pipeline of products, stored ready-to-use, that are derived from human placenta, a non-controversial, non-embryonic, adult stem cell source.

 

In the company’s news yesterday,

 

Pluristem Therapeutics Inc. announced that the US Food & Drug Administration (FDA) has given the company clearance to begin a Phase I clinical trial for the treatment of Critical Limb Ischemia (CLI), the end stage of peripheral artery disease (PAD), using Pluristem’s PLX-PAD. This will be the first clinical trial using PLX-PAD, Pluristem’s placenta-derived stem cells that are expanded using the company’s proprietary 3D PluriX™ technology.

 

PLX-PAD is a unique one-size-fits-all product that doesn’t require tissue matching before being administered to patients. According to the press release, PLX-PAD will be administered to patients considered “late stage” and defined as patients afflicted with CLI that have not responded to traditional medical or surgical interventions.

 

Zami Aberman, Chairman, President and CEO of Pluriste, commented, “We are excited the FDA has cleared our IND application for our PLX-PAD product so quickly. PLX-PAD is our first product candidate in our PLX pipeline and this clinical trial will be the first time a placenta-derived stem cell product, grown using our 3D expansion technology, will be used in humans.”

 

He added, “Our PLX cells are an off-the-shelf, one-size-fits-all product that needs no tissue matching prior to being administered to patients. We believe this unique approach can provide patients with an affordable, immediate source of cell therapy and will position Pluristem as a leader in the cell therapy field.”

 

About QualityStocks

 

QualityStocks, based in Scottsdale, Arizona is a free service that collects data from hundreds Small-Cap and Micro-Cap online Investment Newsletters into one Free Daily Newsletter Report. QualityStocks is dedicated to assisting emerging public companies with their advertising efforts and now has over 500,000+ subscribers that receive The Daily Stock Newsletters.

 

Please see disclaimer on QualityStocks website: http://Disclaimer.QualityStocks.net 

 

Forward-Looking Statement:

This release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. Risks and uncertainties applicable to the company and its business could cause the company's actual results to differ materially from those indicated in any forward-looking statements.