Navigation Links
Kosan Presents Data on Cardiac Safety Profile of Hsp90 Inhibitor,Tanespimycin (KOS-953) at AACR

Tanespimycin Shown to Have No Effect on QTc Interval

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).

About Kosan

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 green@kosan.com

Web site: http://www.kosan.com/

Ticker Symbol: (NASDAQ-NMS:KOSN)

Terms and conditions of use apply
Copyright © 2007 PR Newswire Association LLC. All rights reserved.
A United Business Media Company


'"/>




Related medicine technology :

1. Kosan Presents Promising Phase 1 Data on Second-Generation Hsp90 Inhibitor, Alvespimycin, Showing Antitumor Activity in Refractory Breast and Ovarian Cancers at ASCO
2. Kosan Presents Phase 1 Data Showing Promising Antitumor Activity and Safety Profile of Epothilone KOS-1584 at ASCO
3. Kosan Presents Data on Lead Hsp90 Inhibitor, Tanespimycin, Showing Promising Antitumor Activity in Multiple Myeloma at ASCO
4. Kosan Presents Preliminary Phase 2 Data Showing Antitumor Activity of Hsp90 Inhibitor Tanespimycin in Metastatic Melanoma at ASCO
5. Kosan Presents Preclinical Data on Nuclear Export Inhibitors, Novel Anticancer Agents, at AACR
6. Kosan Presents Preclinical Antitumor and Safety Data On Next-Generation Epothilone KOS-1803 at AACR
7. Kosan Announces Data Presentations at Upcoming AACR Annual Meeting
8. Inspiration Biopharmaceuticals Presents Data From Hemophilia Program at International Society On Thrombosis and Haemostasis (ISTH) Annual Meeting
9. European Society for Medical Oncology (ESMO) Presents Data from the Clinical Trial of MediGenes Cancer-Killing Virus in Press Conference
10. Cytogen Presents Phase 1 Data Showing Promising Antitumor Activity and Safety Profile of Quadramet at International Myeloma Workshop
11. SemBioSys Presents Positive Insulin Data at the American Diabetes Association Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... The Academy of Managed Care Pharmacy (AMCP) ... would allow biopharmaceutical companies to more easily share health ... and coverage decisions, a move that addresses the growing ... The recommendations address restrictions in the sharing of ... label, a prohibition that hinders decision makers from accessing ...
(Date:6/24/2016)... 24, 2016 Research and Markets has ... Companion Diagnostic Tests" report to their offering. ... Diagnostics The World Market for Companion Diagnostics ... diagnostics. Market analysis in the report includes the following: ... Vitro Diagnostic Kits) by Region (N. America, EU, ROW), 2015-2020 ...
(Date:6/24/2016)... NAMUR , Belgium , ...  (NYSE MKT: VNRX), today announced the appointment of ... Board of Directors as a Non-Executive Director, effective ... the Company,s Audit, Compensation and Nominations and Governance ... Board, Dr. Futcher will provide independent expertise and ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... June 27, 2016 , ... A revolution is ... emergency ambulance transport experience for the millions of people who require these medical ... the taxi industry through the use of technology. Now, SmartEMS has put forth ...
(Date:6/26/2016)... ... June 26, 2016 , ... PawPaws brand pet supplements owned ... developed to enhance the health of felines. The formula is all-natural and is made ... in the PawPaws Cat Kidney Support Supplement Soft Chews are Astragalus Root ...
(Date:6/25/2016)... ... ... temporary closing of Bruton Memorial Library on June 21 due to a possible lice infestation, ... aspect of head lice: the parasite’s ability to live away from a human host, and ... necessary one in the event that lice have simply gotten out of control. , As ...
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, ... Bronze Wellness at Work award to iHire in recognition of their exemplary accomplishments in ... the 7th annual Maryland Workplace Health & Wellness Symposium at the BWI Marriott in ...
(Date:6/24/2016)... ... 24, 2016 , ... Marcy was in a crisis. Her son James, eight, was out of ... verbally and physically. , “When something upset him, he couldn’t control his emotions,” remembers Marcy. ... throw rocks at my other children and say he was going to kill them. ...
Breaking Medicine News(10 mins):