Telik Announces Presentation of TLK286 Phase 1 Results At American Society of Clinical Oncology Meeting
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Saturday May 12, 1102 am Eastern Time
Press Release
SOUTH SAN FRANCISCO, Calif.(BW HealthWire)May 12, 2001Telik, Inc. (NasdaqTELK news) today presented the Phase 1 study results for its TLK286 product candidate for the treatment of refractory cancers at the 37th Annual Meeting of the American Society of Clinical Oncology in San Francisco.
A total of 50 patients have been enrolled in the Phase 1 trial, including 35 patients in the completed Schedule (A) and 15 patients in the ongoing Schedule (B). Patients in Schedule (A) received two doses of TLK286 administrated once every three weeks, with tumor assessment on day 43. Those who showed evidence of clinical benefit continued to receive TLK286 until disease progression. Schedule (B) consists of weekly doses of TLK286 for six weeks, with continued treatment for patients showing evidence of clinical benefit. All of the patients treated had been heavily pretreated with a median of four prior chemotherapy regimens. Cancer types included colorectal, renal, sarcomas, nonsmall cell lung, bladder, breast and others.
Overall results from the trial indicate that TLK286 is welltolerated over a wide range of doses in two dosing schedules. Evidence of clinical benefit, defined as prolonged disease stabilization or tumor regression, was observed in 11 of the 32 patients treated in Schedule (A) and in 3 of the 7 patients currently evaluable in Schedule (B).
Based on the favorable safety profile including lack of bone marrow toxicity, a common side effect of standard chemotherapy, and the evidence of clinical benefit, Telik initiated a Phase 2 trial of TLK286 in patients with refractory colorectal cancer in March 2001. Telik anticipates initiating additional Phase 2 trials in ovarian and nonsmall cell lung cancer shortly.
"TLK286 has been shown to be very safe and welltolerated in the Phase 1 study,'' said W. David Henner, M.D., Ph.D., Telik's vice president for clinical research. "These results, combined with the observations of disease stabilization or tumor regression, warrants advancement of TLK286 into Phase 2 studies.''
The Phase 2 trial in colorectal cancer will be conducted under the direction of Lee S. Rosen, M.D., director of the Cancer Therapy Development Program at the University of California, Los Angeles Jonsson Comprehensive Cancer Center and other sites. Dr. Rosen was the principal investigator for the Phase 1 trial. "I am pleased to continue our participation in the development of TLK286 as principal investigator at UCLA for the Phase 2 study of TLK286 in patients with advanced colorectal cancer,'' said Dr. Rosen.
"TLK286 was identified through the application of our proprietary TRAP chemogenomics technology and has the potential to benefit patients with difficult to treat major refractory types of tumors,'' said Michael M. Wick, M.D., Ph.D., Telik's chairman and chief executive officer. "Telik looks forward to expanding the Phase 2 program with additional major comprehensive cancer centers.''
According to the American Cancer Society statistics, colorectal, nonsmall cell lung cancer and ovarian cancers afflict large numbers of patients and represents major unmet clinical needs. Colorectal cancer is the third most common cancer in both men and women with an estimated 130,200 new cases diagnosed in 2000. Approximately, 165,000 new cases of lung cancer, accounting for 14% of all cancers were identified last year, while ovarian cancer struck more than 23,000 women and is the second most common gynecologic malignancy.
TLK286 is a small molecule drug candidate that was developed through the application of Telik's proprietary TRAP chemogenomics technology. TLK286 has a novel mechanism of activation that targets tumors that overexpress GST P11, a protein that plays an important role in the development of resistance to commonly used chemotherapeutic drugs. Its mechanism of activation in tumor cells suggests a potentially safer, more effective and directed cancer drug, especially against resistant cancers.
Telik, Inc. of South San Francisco, California, is a biopharmaceutical company working to discover, develop, and commercialize small molecule drugs to treat serious diseases for which there is significant demand for new therapies. The company's most advanced drug development programs includeTLK286, a tumor activated drug candidate currently in Phase 2 clinical testing; TLK199, a drug candidate for the treatment of depletion of infectionfighting white blood cells that occurs as a toxic side effect of cancer therapy as well as in other blood diseases, and a family of orally active insulin receptor activators for Type 2 diabetes. Telik's product candidates were discovered using its proprietary technology, TRAP, which enables the rapid and efficient discovery of small molecule drug candidates. Additional information is available at www.telik.com.
*** POSTED JUNE 29, 2001 ***