מתוך medicontext.co.il
NEW YORK (Reuters Health) – Cubist Pharmaceuticals Inc. announced on Thursday that a phase III trial has shown its investigational anti-infective Cidecin (daptomycin) to be as effective as competitor agents in treating the signs and symptoms of skin and soft tissue infections–the study's primary endpoint.
A spokeswoman for the company told Reuters Health that more detailed data would be available after further analyses are conducted. Cubist plans to present the trial results at the upcoming Infectious Diseases Society of America meeting on October 25-28 in San Francisco.
The is the second such structured trial the company has conducted in order to gather data to support a US Food and Drug Administration (FDA) filing on the drug.
Earlier this year, the Cambridge, Massachusetts-based company released data from the first phase III trial that showed Cidecin as effective as the competitor products–semi-synthetic penicillin or vancomycin–in treating S. aureus and Hemolytic streptococci infections.
The company is currently conducting two phase III trials examining Cidecin in treating community-acquired pneumonia.
Results from both the skin and soft-tissue and community-acquired pneumonia studies are expected to be compiled and ready for a mid-2002 FDA filing.
During early Thursday afternoon trading on the NASDAQ, shares of Cubist were down 0.30 at 37.60.
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