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Kosan abandons phase II cancer study

Following disappointing results, Kosan Biosciences has discontinued its phase II clinical trial in hormone refractory prostate cancer of KOS-862, its investigational anticancer compound which it is developing in collaboration with Roche.

Although some clinical activity was observed, the trial did not meet its endpoint for the number of patients with a response to therapy. However, Kosan will continue with clinical trials for KOS-862 in breast cancer.

The KOS-202 trial was conducted in patients with advanced hormone refractory prostate cancer who had previously progressed on docetaxel-based therapy for metastatic disease.

Patients received KOS-862 as single-agent therapy, with response assessed every 4 weeks. Based on the data from the interim analysis, the toxicity profile in the KOS-202 trial was not dissimilar to the profile observed in a phase II clinical trial of KOS-862 in non-small cell lung cancer. However, there was a higher incidence of adverse events resulting in patient withdrawal in the prostate cancer trial.

“While we are disappointed that the prostate trial will not proceed, we are encouraged by the potential of KOS-862 as a monotherapy and in combination with other standard chemotherapeutics in patients with breast cancer,” said Dr Daniel Santi, chairman and CEO of Kosan.

Roche and Kosan initiated their global development and commercialization agreement for KOS-862 and other compounds in the epothilone class in September 2002.