StemCells, Inc. Names Elizabeth Leininger Vice President, Regulatory Affairs and Quality Assurance
PALO ALTO, Calif., (April 10, 2006)— StemCells, Inc. (NASDAQ: STEM) today announced that Elizabeth Leininger, Ph.D. has been appointed Vice President, Regulatory Affairs and Quality Assurance . Dr. Leininger will direct and manage the Company’s global regulatory affairs strategy and help guide the development of new stem cell therapies from the preclinical stage to clinical testing. Additionally, she will be responsible for ensuring that the Company’s tissue acquisition and cell processing operations fully comply with all applicable regulations.
Dr. Leininger has more than 18 years of diverse experience as a regulatory affairs and quality assurance professional. Prior to joining StemCells, she worked as vice president of regulatory affairs and quality at BAS Medical, where she was responsible for the quality assurance function, regulatory strategy and submissions to support the development of a recombinant biotherapeutic, Relaxin. Her prior experience includes working as a senior consultant at Biologics Consulting Group, director and head of adult vaccines, North American regulatory affairs at GlaxoSmithKline and director of regulatory affairs at Chiron Corporation, responsible for the development of vaccines and biotech products. Dr. Leininger began her professional career as a staff fellow and product reviewer at the Center for Biologics Evaluation and Research at the U.S. Food and Drug Administration.
“ Elizabeth’s extensive experience and leadership role in gaining regulatory approval for new biologics will be invaluable to StemCells as we pursue our goal of bringing novel stem cell therapeutics into clinical practice. We are about to initiate the first clinical trial of our human neural stem cell, HuCNS-SC™, in Batten disease and plan to advance other preclinical programs into the clinic,” said Martin McGlynn, President and Chief Executive Officer of StemCells. “Moreover, given her broad background in quality assurance, Elizabeth will provide expert guidance and direction to all aspects of our tissue and cell-processing operations.”
“Stem cell technology presents new regulatory challenges to the world of biologic product development. I am honored to join StemCells, Inc., and negotiate the regulatory pathway to enable the use of stem cells as therapeutic molecules,” said Dr. Leininger. “I look forward to joining this pioneering organization.”
Dr. Leininger is a member of the Parenteral Drug Association (PDA), the Regulatory Affairs Professional Society (RAPS), as well as a board member of the PDA West Coast Chapter. Dr. Leininger earned her Ph.D. in chemistry from the University of North Carolina at Chapel Hill.
About StemCells, Inc.
StemCells, Inc. is a clinical stage biotechnology company focused on the discovery, development and commercialization of stem cell-based therapeutics to treat diseases of the nervous system, liver and pancreas. The Company’s stem cell programs seek to repair or repopulate neural or other tissue that has been damaged or lost as a result of disease or injury. StemCells is the first company to directly identify and isolate human neural stem cells from normal brain tissue. These stem cells are expandable into cell banks for therapeutic use, which demonstrates the feasibility of using normal, non-genetically modified cells as cell-based therapies. StemCells is a publicly traded company solely focused on stem cell research and development and has approximately 40 U.S. and 100 non-U.S. patents. Further information about the Company is available on its web site at: www.stemcellsinc.com.
Apart from statements of historical facts, the text of this press release constitutes forward-looking statements regarding, among other things, the future business operations of StemCells, Inc. (the “Company”) and its ability to conduct clinical trials as well as its research and product development efforts. The forward-looking statements speak only as of the date of this news release. StemCells does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Such statements reflect management’s current views and are based on certain assumptions that may or may not ultimately prove valid. The Company’s actual results may vary materially from those contemplated in the forward-looking statements due to risks and uncertainties to which the Company is subject, including whether preclinical research results will be able to be translated into treatment for humans; uncertainty whether the clinical investigators will be able to identify suitable candidates for the Batten disease clinical trial; uncertainty as to whether the FDA will permit the Company to continue clinical testing in the Batten disease trial or in future clinical trials of proposed therapies for other diseases or conditions despite the novel and unproven nature of the Company’s technology; uncertainties regarding the Company’s ability to obtain the capital resources needed to continue its current research and development operations and to conduct the research, preclinical development and clinical trials necessary for regulatory approvals; uncertainty regarding the validity and enforceability of the Company’s patents; uncertainty as to whether HuCNS-SC and any products that may be generated in the future in the Company’s stem cell programs will prove safe and clinically effective and not cause tumors or other side effects; uncertainty as to whether the Company will achieve revenues from product sales or become profitable; and other factors that are described in Item 1A in the Company’s Annual Report on Form 10-K in the section titled “Risk Factors.”
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CONTACT: StemCells, Inc.
Rodney Young
Chief Financial Officer
650-475-3100, Ext. 105
irpr@stemcellsinc.com
or
Schwartz Communications, Inc.
781-684-0770
stemcells@schwartz-pr.com
SOURCE: StemCells, Inc.
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