Pluristem Completes Large Scale Cell Therapy Formulation for Commercial and Clinical Trial Use

HAIFA, Israel, Nov. 7, 2012 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapies, announced today the Company has successfully completed the integration and testing of its new scaled-up formulation and manufacturing process to produce high-yield quantities of its Placental eXpanded (PLX) cells for clinical trials and potential commercial use. The increased automation and larger scale process allows the company to produce billions of live cells simultaneously.

As part of its manufacturing process, Pluristem has optimized growth conditions to maximize yields with lower costs. The company has minimized open manipulation steps in order to improve the aseptic quality and safety of the product. Critical steps have been automated including the process of harvesting and purification; the integration of closed system washing and concentration steps, and the product's final packaging has been changed to an aseptically automated vial system. In the past 15 months, Pluristem has invested resources and efforts to develop technologies resulting in an efficient, cutting edge production line. All of the integrated changes have been tested and will be integrated into Pluristem's new production site in Israel.

Pluristem recently announced it is in the final steps of building out its new manufacturing facility, which will have the capacity to produce commercial grade PLX cells. Once completed, and following regulators' approval, the new facility would have the capacity to produce PLX cells for the treatment of over 150,000 patients annually estimated by Pluristem at $1 billion in production value.

"This new large scale manufacturing process allows us to run numerous clinical trials simultaneously around the globe, and also prepares us for potential commercial availability," stated Zami Aberman, Chairman and CEO of Pluristem. "Our progress with both our manufacturing process and facility are well on track."

About Pluristem Therapeutics

Pluristem Therapeutics Inc. (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 and patent applications portfolio, company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit http://www.pluristem.com and follow Pluristem on Twitter@Pluristem, the content of which is not part of this press release.

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Pluristem Completes Large Scale Cell Therapy Formulation for Commercial and Clinical Trial Use