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Wednesday September 29, 6:30 am Eastern Time
Company Press Release
SOURCE: Gliatech Inc.
Gliatech Completes Phase I Clinical Study for
Perceptin
-- Preparation of Phase II Submission in Progress --
CLEVELAND, Sept. 29 /PRNewswire/ -- Gliatech Inc. (Nasdaq: GLIA - news) today announced at the Warburg Dillon
Read Global Life Sciences Conference the successful completion of the Phase I multiple-dose clinical study of Perceptin(TM).
Perceptin(TM) is the Company's selective histamine H3 receptor antagonist which is being developed for potential use in
central nervous system diseases involving attention/learning or sleep disorders. The potential uses for Perceptin(TM) include
Attention Deficit Hyperactivity Disorder (ADHD), dementia associated with Alzheimer's Disease and sleep disorders, including
narcolepsy.
This recently completed Phase I multiple-dose study was a double-blind, randomized, placebo-controlled trial to investigate the
safety, tolerability and pharmacokinetic profile of Perceptin(TM). Several doses of Perceptin(TM) or placebo were
administered to healthy volunteers for up to two weeks following either a once or twice a day dosing schedule.
The results from this study confirmed and extended the findings from a previously completed Phase I rising single-dose study.
There were no serious adverse events at the doses evaluated and no clinically significant differences between treated and
control patients in blood chemistry or hematological measurements after a two-week therapy with Perceptin(TM).
Pharmacokinetic analysis indicated blood levels in patients treated with Perceptin(TM) were achieved and maintained in excess
of those required for pharmacological effect based on preclinical studies. Additionally, two-week treatment with Perceptin(TM)
confirmed a plasma half-life (T1/2) which should allow for once daily dosing.
''Both Phase I studies have now been completed and confirm that Perceptin(TM) is well tolerated and amenable to once daily
dosing,'' said Thomas O. Oesterling, Ph.D., Chairman and Chief Executive Officer of Gliatech. ''Based on the favorable results
in the two Phase I studies, preparation of a submission of the clinical data to appropriate regulatory agencies is underway.''
Histamine is a chemical messenger released from certain neurons in the brain, which regulates sleep/wake states and modulates
levels of arousal and alertness in the conscious state. The histamine H3 receptor is predominantly found in the brain wherein it
regulates neurotransmitter release. This novel class of therapeutics may be useful in central nervous system diseases involving
attention/learning or sleep disorders. Upon further regulatory review and approval, Gliatech plans to initiate additional clinical
trials including targeting patient populations such as ADHD, AD, as well as various sleep disorders.
''The profile for this selective histamine H3 receptor antagonist is unique. If it is effective, it would provide a novel approach for
the treatment of ADHD,'' stated James Swanson, Ph.D., Professor of Pediatrics and Director of the University of California
Irvine Child Development Center. ''Development of novel, safe and effective non-stimulant therapies for treatment of attention
and learning problems of adults and children with ADHD may offer a tremendous advance over current medications.''
Gliatech was formed in 1988 to discover, develop and commercialize therapeutic products based on understanding the
properties of glial cells, a major component of the nervous system. The Company applies its core glial research to developing
innovative products for major unmet human health care needs.
Certain statements in this press release constitute ''forward-looking statements'' that are subject to risks and uncertainties which
may cause the actual results of the Company to be different from expectations expressed or implied by such forward looking
statements. Such factors include, but are not limited to, uncertainty of continued development and market acceptance of the
Company's products, the uncertainty of the continued development of Perceptin(TM), the utility of Perceptin(TM) in treating
nervous system diseases and other risk factors detailed in the Company's SEC filings.
SOURCE: Gliatech Inc. |
