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Advancis to hold additional adult Amoxicillin PULSYS phase III trial
Germantown, MD | Tuesday, September 20, 2005, 08:00 Hrs  [IST]

Advancis Pharmaceutical Corporation, a pharmaceutical company focused on developing and commercializing novel anti-infective products, will conduct a new Phase III trial for its Amoxicillin PULSYS product candidate in adults and adolescents with pharyngitis/tonsillitis due to Group A strep infections. Enrolment in the clinical trial is expected begin in the fourth quarter of 2005.

Following extensive analysis of data from the Company's recently concluded unsuccessful Amoxicillin PULSYS clinical trials, Advancis has decided to extend the length of treatment in a new Phase III trial in adults and adolescents from seven days to 10 days for its product candidate.

Edward M. Rudnic, chairman, president, and CEO of Advancis said, "As a result of what we learned from our prior trials, we believe that our current once-a-day formulation dosed for 10 days has the potential to provide the efficacy required for product approval. In addition, we believe this therapy may yield eradication rates that are competitive with the most efficacious treatments for strep throat. This therapy would utilize Advancis' proprietary PULSYS technology and preserve the product's strongest marketing appeal of once-daily dosing."

Meantime, Advancis has reached an agreement in principle to sell the US rights to the Keflex brand of cephalexin to a private company. The company has agreed to terms for the sale of its Keflex assets and has received a $1 million non-refundable upfront payment.

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