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Third Quarter 2007 Highlights
-- Kosan reached a binding agreement with the U.S. Food and Drug
Administration (FDA) on the design of Kosan's TIME-1 clinical trial, a
pivotal Phase 3 trial of Kosan's Hsp90 inhibitor tanespimycin as a
treatment for patients with multiple myeloma, through a Special
Protocol Assessment (SPA) process with the FDA. Kosan also completed
the "Scientific Advice" process with the centralized European Medicines
Agency (EMEA) for TIME-1.
-- At the 2007 Breast Cancer Symposium of the American Society of Clinical
Oncology (ASCO), Kosan presented updated data from a Phase 1 clinical
trial showing that Kosan's Hsp90 inhibitor alvespimycin demonstrated
antitumor activity and tolerability in combination with trastuzumab
(Herceptin(R)), with clinical benefit observed in 42% of evaluable
patients (8 of 19 evaluable) with HER2-positive metastatic breast
cancer.
-- Pfizer Inc. initiated a Phase 1 clinical trial designed to test the
safety, tolerability and pharmacokinetics of motilin receptor agonist
KOS-2187, a selective and potent motilin receptor agonist being
developed for the treatment of gastroesophageal reflux disease (GERD)
and potentially other gastrointestinal disorders.
-- Kosan completed preparations and is planning to initiate later this
quarter a Phase 2 clinical trial of alvespimycin in patients with
newly-diagnosed HER2-positive metastatic breast cance
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