Kosan Initiates Phase 2 Trial of Epothilone KOS-1584 in Non-Small Cell Lung Cancer
Monday April 14, 6:00 am ET
HAYWARD, Calif., April 14 /PRNewswire-FirstCall/ -- Kosan Biosciences Incorporated (Nasdaq: KOSN - News) today announced that the Phase 2 trial of epothilone KOS-1584 in patients with non-small cell lung cancer has been initiated. The Phase 2 trial is an open-label, multi-center, monotherapy study of KOS-1584 in patients with measurable advanced or metastatic non-small cell lung cancer who have previously received only one prior chemotherapy regimen. The primary endpoint of the Phase 2 trial is objective response rate. Secondary endpoints include progression-free survival, time to progression, time to treatment failure, time to response, duration of response and overall survival. KOS-1584 will be administered via a 3-hour intravenous infusion weekly for two weeks out of every three weeks at a dose of 25 mg/m(2). The Phase 2 trial will enroll up to 50 patients in a two-stage Simon design.
"We have been impressed by the breadth and level of activity and tolerability we have observed with KOS-1584 in our Phase 1 trials and believe that KOS-1584 has competitive potential in the emerging epothilone class of anticancer agents," said Helen S. Kim, Kosan's President and Chief Executive Officer. "Kosan's epothilone strategy is to advance KOS-1584 to its next inflection point while seeking a corporate partner to conduct a registration program and advance our preclinical product candidate, KOS-1803, into clinical development. We believe that KOS-1584's therapeutic profile and potential for near-term commercialization enhance its value for potential pharmaceutical collaborators."
KOS-1584 is a member of a class of cytotoxic macrolides (epothilones) capable of causing mitotic arrest by polymerization of cellular microtubules. Since microtubules are essential for mitosis, motility, secretion and proliferation, the observed antitumor effects of epothilones have been attributed to their ability to initiate cell death by inhibiting such processes. KOS-1584 has demonstrated in vitro cytotoxicity, more potent or equipotent to that of Taxol® (paclitaxel) in a panel of human cell lines. KOS-1584 has shown significant antitumor activity in a range of xenograft models, including non-small cell lung cancer models resistant to paclitaxel and those expressing multidrug resistance. A long elimination half-life was seen in Phase I trials. KOS-1584 has demonstrated antitumor activity and favorable tolerability in Phase 1 trials in patients with solid tumors, including substantial tumor shrinkage measured by objective responses in non-small cell lung, ovarian and pancreatic cancers, as well as durable stable disease in many additional tumors.
