Wednesday November 8, 9:05 am Eastern Time
Press Release
Telik Announces Positive Interim Phase I Results With TLK286 in Refractory Cancer Patients
Company Plans to Begin Phase II Trials of TLK286 in 2001
SOUTH SAN FRANCISCO, Calif.--(BW HealthWire)--Nov. 8, 2000--Telik, Inc. (Nasdaq: TELK - news) announced today the presentation of positive interim Phase I results with its TLK286 cancer drug product candidate. The data were presented today at the 11th annual National Cancer Institute (NCI) - European Organization for Research and Treatment of Cancer (EORTC) - American Association for Cancer Research (AACR) Symposium on New Drugs in Cancer Therapy in Amsterdam.
The trial was initiated under the direction of Lee S. Rosen, M.D., at the University of California, Los Angeles (UCLA) Jonsson Comprehensive Cancer Center and was designed to determine the safety, tolerability and efficacy of TLK286 in patients with advanced cancers. A total of 36 patients were included in the preliminary analysis of this open label, dose-escalation study. These patients had refractory cancers including non-small cell lung, colorectal, breast, and sarcomas, among other cancers. Patients had failed multiple courses of chemotherapy, radiation, and experimental treatments.
Patients received either one of two dose schedules: Regimen A consisting of TLK286 administered once every three weeks for six weeks or Regimen B consisting of lower doses of TLK286 administered once weekly for six weeks. Patients who had evidence of clinical benefit were allowed to continue to receive treatment until disease progression occurred. Dose levels evaluated ranged from 60 mg/m2 to 960 mg/m2 in Regimen A and 60 mg/m2 to 120 mg/m2 in Regimen B.
TLK286 has been safely administered and well-tolerated in both dosing schedules. In addition, evidence of clinical benefit, defined as disease stabilization or signs of clinical activity, has been observed. The longest duration of patient treatment so far has been eight cycles, or approximately six months. Patient enrollment and dose-escalation is continuing in order to establish the maximum tolerated doses (MTDs) for both dose schedules.
``These preliminary Phase I results are encouraging for several reasons,'' said Lee S. Rosen, M.D., director of the Cancer Therapy Development Program at the UCLA Jonsson Comprehensive Cancer Center and principal investigator for the trial. ``We have seen that TLK286 is safe and well-tolerated over a wide range of doses and two dose schedules, across a large number of patients with a broad spectrum of cancers for a Phase I trial, and in both short and long term use. In addition, we have seen disease stabilization or clinical activity in 11 of 31 of the patients evaluable for clinical benefit. Since these biologic responses have been observed across multiple refractory cancers, we believe that TLK286 might affect a fundamental mechanism responsible for resistance to chemotherapy.'' Significant additional testing of TLK286 will be needed, however, to confirm these results.
``Based on our experience with Phase I trials of new cancer drugs, these results are encouraging in terms of both the safety and biologic activity observed,'' Dr. Rosen said. ``Clearly, advancement of TLK286 into Phase II testing is warranted.''
``We share Dr. Rosen's enthusiasm for TLK286, the first member of our deep product candidate pipeline to enter clinical testing, based on the preclinical and preliminary clinical results,'' said Michael M. Wick, M.D., Ph.D., chairman and chief executive officer. ``We have identified clinical cancer indications and investigational sites for Phase II clinical development of TLK286. Given the combination of a favorable safety profile in both short and long term use and positive biologic activity, we continue to expect to initiate Phase II clinical trials in the first quarter of 2001.''>>snip<< |
