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Old 12-21-2005, 03:09 PM   #1
Christine MH-UK
Senior Member
 
Join Date: Sep 2005
Posts: 414
PHASE II CLINICAL TRIAL OF KOS-953 & HERCEPTIN® FOR Stage IV

http://www.kosan.com/news_view_pr.cfm?id=267

"San Antonio, TX – December 8, 2005 – Kosan Biosciences Incorporated (Nasdaq: KOSN) today announced the initiation of a Phase II clinical trial in patients with HER2-positive metastatic breast cancer, administering KOS-953 in combination with trastuzumab (Herceptin®). In addition, interim data from the Phase Ib dose-escalating clinical trial using this combination was presented today at the 28th Annual San Antonio Breast Cancer Symposium. KOS-953 is the Company’s proprietary formulation of the heat shock protein 90 (Hsp90) inhibitor, 17-AAG.


The Phase Ib dose-escalating and Phase II clinical trials of KOS-953 in combination with trastuzumab are being conducted at Memorial Sloan-Kettering Cancer Center and Arizona Cancer Center. The Phase II trial will enroll patients with HER2-positive metastatic breast cancer whose disease has progressed following treatment with trastuzumab in either the adjuvant or metastatic setting. In this Phase II trial, patients will receive weekly doses of KOS-953 following the infusion of trastuzumab. The primary objective of the protocol is to assess tumor response using standard RECIST criteria.



The poster presentation (“Trastuzumab and KOS-953 (17-AAG) is Feasible and Active in Patients with Metastatic Breast Cancer: Preliminary Results of a Phase 1/2 Study” – abstract #1095) included results from 25 patients, including 17 evaluable patients with HER2-positive metastatic breast cancer who had received a median number of three prior trastuzumab-based therapies. A confirmed partial response was observed in a heavily pre-treated patient; three additional patients had tumor regression, including one patient with complete resolution of an adrenal metastasis by FDG-PET imaging. All patients had progressed on multiple prior trastuzumab-based regimens. Nine patients had stable disease that lasted for at least three months. (Four of these patients had stable disease in excess of six months.)





“Preclinical research conducted in the laboratory of Dr. Neal Rosen at Memorial Sloan-Kettering Cancer Center demonstrated the antitumor potential of Hsp90 inhibition in HER2-positive animal models,” said Clifford Hudis, M.D., Chief of the Breast Cancer Medicine Service and Associate Attending Physician at Memorial Sloan-Kettering Cancer Center, New York. “The encouraging antitumor activity observed in the dose-escalating trial among heavily pre-treated patients supports continuation of this combination into a Phase II clinical trial.”



The Phase Ib clinical trial was designed to determine the recommended Phase II dose and toxicity of KOS-953 in combination with standard doses of trastuzumab. According to the trial protocol, patients received standard weekly doses of trastuzumab followed by KOS-953 in escalating doses. Ten patients received the final recommended Phase II dose of KOS-953. Drug-related toxicities were primarily fatigue and gastrointestinal (nausea, vomiting, diarrhea) that were amenable to supportive care. There was no marrow suppression and minimal hepatoxicity. No cardiovascular toxicity was observed. Pharmacokinetic parameters for KOS-953 in this combination were similar to KOS-953 administered as a single agent; KOS-953 had no effect on the kinetics of trastuzumab."

The rest is on heat shock protein 90 inhibitors more generally.
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