HAYWARD, Calif., April 16, 2007 /PRNewswire/ -- Kosan Biosciences Incorporated today presented safety data from preclinical and clinical studies of its lead Hsp90 inhibitor, tanespimycin (KOS-953). Serial electrocardiogram (ECG) monitoring of patients was conducted in four Phase 1 trials of tanespimycin. Cardiac monitoring analyses were conducted in more than 85 patients. Tanespimycin was found to have no effect on QTc interval (a measure of the heart's electrical cycle) in these patients based on data analyses from manually read ECGs in a central laboratory or by site cardiologists.
"The analyses performed by cardiac specialists confirm that tanespimycin had no effect on QTc interval," said Robert G. Johnson, Jr., M.D., Ph.D., Kosan's President and Chief Executive Officer. "Moreover, it is clear from these analyses that two previously reported incidents of possible QTc interval effects in studies of tanespimycin conducted by the National Cancer Institute's (NCI) Cancer Therapy Evaluation Program (CTEP) were based on artifactual QTc prolongation data from automated computer reads and were unrelated to drug product. Our Hsp90 inhibitors have been administered to more than 600 patients in trials conducted by Kosan and by the NCI and the safety profile of the compound class has been well characterized. With the anticipated initiation of our TIME registration program for tanespimycin in patients with multiple myeloma, and with plans underway to advance second- generation alvespimycin into later-stage trials in patients with HER2-positive metastatic breast cancer, we look forward to further characterizing the efficacy and safety profiles of these exciting and potentially important new cancer therapies."
The data from the cardiac monitoring analyses were presented at the 2007 Annual Meeting of the American Association for Cancer Research (AACR) in a p oster on Sunday, April 15, 2007, titled, "Tanespimycin (17-AAG, KOS-953): No Effects on QTc Interval Using Two Formulations" (abstract #1544). A second poster, entitled "Preclinical Safety Profile of Tanespimycin (KOS-953) -- a Heat Shock Protein 90 (Hsp90) Inhibitor" (abstract #1568) reported on preclinical toxicology studies with tanespimycin and confirmed that in these studies tanespimycin had no adverse effect on QTc interval.
Results of Cardiac Monitoring Analyses
To evaluate whether tanespimycin had any effect on the QTc interval, patients in clinical trials of tanespimycin underwent ECG monitoring prior to the study, before dosing, near the expected time of maximal plasma concentrations within 20 minutes after the infusion, as well as at the end of the study. ECG intervals were measured by a dedicated cardiologist at Memorial Sloan-Kettering Cancer Center (MSKCC) or by a central cardiologist at an independent third-party laboratory.
In trials conducted by MSKCC, under the auspices of CTEP, tanespimycin was administered in an egg-phospholipid/4% DMSO formulation. In trials of tanespimycin sponsored by Kosan, tanespimycin was administered in a Cremophor-based formulation. There was no evidence in any of these trials that tanespimycin prolonged the QTc interval (a prolongation of the interval can lead to ventricular arrhythmia).
Kosan Biosciences is a biotechnology company advancing two new classes of anticancer agents through clinical development -- Hsp90 (heat shock protein 90) inhibitors and epothilones. Kosan is leveraging its proprietary discovery platform to generate a pipeline of potentially significant product candidates, primarily in the area of oncology.
Hsp90 inhibitors have a novel mechanism of action targeting multiple pathways involved in cancer cell growth and survival. Kosan's proprietary formulation of tanespimycin (KOS-953) is currently in Phase 1 and 2 clinical trials, primarily for multipl e myeloma in combination with Velcade(R) (bortezomib) and HER2-positive metastatic breast cancer in combination with Herceptin(R) (trastuzumab). In addition, intravenous and oral formulations of Kosan's second-generation Hsp90 inhibitor, alvespimycin (KOS-1022), are being evaluated in Phase 1 clinical trials.
Epothilones inhibit cell division with a mechanism of action similar to taxanes, one of the most successful classes of anti-tumor agents. KOS-1584 is in Phase 1 clinical trials in patients with solid tumors. Kosan's epothilone program is partnered with Roche through a global development and commercialization agreement.
For additional information on Kosan Biosciences, please visit the company's website at www.kosan.com.
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 (the "Act"). Such forward-looking statements include but are not limited to statements relating to the further development and potential safety, efficacy and commercialization of Kosan's product candidates; and initiations of clinical trials and the timing thereof. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. There are a number of important factors that could cause the results of Kosan to differ materially from those indicated by these forward-looking statements, including, among others, risks related to the development of Kosan's product candidates, including the risk that studies may not demonstrate safety and efficacy sufficient to initiate clinical trials, continue clinical development, obtain the requisite regulatory approvals or to result in a marketable product; and other risks detailed from time to time in the Company's SEC reports, including its Annual Report on Form 10-K for the year ended December 31, 2006 and ot her periodic filings with the SEC. Kosan does not undertake any obligation to update forward-looking statements.
NOTE: Velcade(R) (bortezomib) is a registered trademark of Millennium Pharmaceuticals, Inc.
Herceptin(R) (trastuzumab) is a registered trademark of Genentech, Inc.
CONTACT: Jane Green, VP, Corporate Communications, +1-510-731-5335, ormobile, +1-415-652-4819, or firstname.lastname@example.org
Web site: http://www.kosan.com/
Ticker Symbol: (NASDAQ-NMS:KOSN)
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