Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Gliatech (GLIA) -- Ignore unavailable to you. Want to Upgrade?

To: Jack Hartmann who wrote (951)	9/29/1999 9:07:00 AM
From: scaram(o)uche	Read Replies (1) \| Respond to of 2001

Go, GLIA! 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.