Pluristem Life Systems Retains Biologics Consulting Group to Pursue FDA Approval of PLX-1
Posted on: Monday, 26 June 2006, 09:00 CDT
Pluristem Life Systems, Inc. (OTCBB:PLRS), a cell therapy company dedicated to the commercialization of stem cell products, announces it has engaged Biologics Consulting Group, Inc. to assist in the Company's pursuit of FDA approval of PLX-1. Pluristem's PLX-1 will enable umbilical cord blood to become an alternative to bone marrow transplant, eliminating the current bone marrow transplant search and match process.
Zami Aberman, CEO of Pluristem, states, "Biologics Consulting Group will advise us on the most expeditious way to pursue FDA approval of PLX-1. Their well-conceived plan includes a detailed assessment of the most effective pathway to approval and then to market. We expect to immediately implement their strategy."
"We are pleased to have been chosen by Pluristem to assist in the development of a regulatory strategy specifically tailored to expedite timely review and approval of PLX-1 by the FDA," notes Dr. Andra E. Miller, Director, Cell and Gene Therapy, Biologics Consulting Group, Inc.
About Biologics Consulting
The Biologics Consulting Group, Inc. is a team of consultants that provide national and international regulatory and product development advice on the development and commercial production of biotechnological and biological products. Staff consists of experts in regulatory affairs, product manufacturing and testing, pharmacology/toxicology, facility inspections, statistics, program management, and clinical trial design and evaluation. Their consultants are former CBER reviewers, certified FDA inspectors, and senior scientists from the biotechnology industry.
About Pluristem
Pluristem Life Systems, Inc. is a cell therapy company dedicated to the commercialization of stem cell therapy products for the treatment of severe blood disorders. Pluristem is discovering and developing call-based therapeutics utilizing adult stem cells expanded in a proprietary bio-reactor that mimics different naturally-occurring physiological environments. Pluristem expects its first products to be cell grafts that will provide an efficient and superior alternative to the standard procedure of bone marrow transplantation to treat blood cancer and other blood disorders.
Safe Harbor Statement
This news release contains statements, which may constitute "forward-looking statements". Those statements include statements regarding the intent, belief or current expectations of Pluristem Life Systems, Inc., and members of our management as well as the assumptions on which such statements are based. Forward-looking statements in this release include:our intention to pursue FDA approval of PLX-1; that PLX -1 will enable umbilical cord blood to become an alternative to bone marrow transplants; that we expect to immediately implement Biologics' strategy; that we are discovering and developing call-based therapeutics; and that we expect our first products to be cell grafts that will provide an alternative to the standard procedure of bone marrow transplantation . Factors which may significantly change or prevent our forward looking statements from fruition include that Biologics' plan may not be able to be implemented and even if implemented, may not succeed; we may be unsuccessful in developing any products; that our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; that we are unable to retain or attract key employees whose knowledge is essential to the development of our products; that unforeseen scientific difficulties develop with our process; that our patents are not sufficient to protect essential aspects of our technology; that competitors may invent better technology; that our products may not work as well as hoped or worse, that our products may harm recipients; and that we may not be able raise funds for development or working capital when we require it. As well, our products may never develop into useful products and even if they do, they may not be approved for sale to the public. For further risk factors see the Company's latest 10-KSB filed with the SEC.
For more information visit our website at www.pluristem.com
Source: Business Wire
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