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Palo Alto, CA, March 27, 2003 — Telik, Inc. (Nasdaq:
TELK) announced the initiation of a randomized, controlled Phase
3 registration trial of TLK286 administered as a single agent in
ovarian cancer patients whose disease has progressed following platinum-based
chemotherapy and one second-line treatment.
The multinational trial, designated the ASSIST-1 (ASsessment
of Survival In Solid Tumors-1)
trial, is expected to enroll approximately 440 women. Patients will
be randomized to a TLK286 treatment group, or to a control group
receiving either Doxil® or Hycamtin®, drugs that are
commonly used in the third-line ovarian cancer setting. The study
is designed to evaluate whether TLK286 treatment reduces the risk
of death, leading to an increase in survival, as compared to the
control group treatments.
Results from a Phase 2 single agent study of TLK286 in ovarian
cancer were presented at the American Society of Clinical Oncology
meeting in May 2002 and at the EORTC/NCI/AACR meeting in November
2002. In this trial, objective tumor responses were observed and
median patient survival was estimated at 17 months by Kaplan-Meier
analysis.
"Ovarian cancer has the highest mortality rate of all gynecologic
malignancies. There is an urgent need for new treatment alternatives
since approximately 75% of new cases of ovarian cancer are diagnosed
at an advanced stage," said Gail L. Brown, M.D., senior vice
president and chief medical officer. "The objective responses
and survival benefit observed with TLK286 in our Phase 2 ovarian
cancer trial, the clinical activity reported in other cancers, including
non-small cell lung, breast and colorectal, as well as the tolerability
profile seen in more than 350 patients, provide a strong foundation
for this Phase 3 trial."
About Ovarian Cancer and TLK286
Approximately 25,400 new cases of ovarian cancer will be diagnosed
in 2003, according to the American Cancer Society. Ovarian cancer
is the sixth most common cause of cancer-related deaths in the U.S.
TLK286 is a small molecule prodrug which is activated by GST P1-1,
an enzyme present in higher levels in many human cancers than in
normal tissues. Upon activation, TLK286 initiates an intracellular
process known as apoptosis, or programmed cell death. Telik has
retained worldwide commercialization rights to TLK286.
About Telik, Inc.
Telik, Inc. of Palo Alto, CA 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 candidate is
TLK286, in a Phase 3 registration trial in advanced ovarian cancer,
and in earlier stage clinical trials in ovarian, non-small cell
lung, breast and colorectal cancer. 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.
You should not rely on forward-looking statements contained in
this press release, including statements regarding Telik’s
ability to successfully develop TLK286 for the treatment of ovarian
cancer or any other cancer, the anticipated timing of the Phase
3 registration trials of TLK286, the tolerability or potential efficacy
of TLK286, the potential of TLK286 to treat one or more types of
cancer, or the potential market for TLK286. Telik can give no assurance
with regard to these statements. None of Telik’s products
have been determined to be safe or effective in humans or been approved
for marketing. TLK286 has been tested only in open-label, uncontrolled
clinical trials. Substantial additional testing, including randomized,
controlled clinical trials, will be necessary prior to seeking marketing
approval. There can be no assurance that such trials will accrue
sufficient patients, be conducted with sufficient quality, in a
timely manner, have a successful outcome, or that regulatory approvals
of TLK286 will be obtained for the treatment of ovarian cancer or
any other indication. In addition, Telik is reliant on external
manufacturing of TLK286, and any interruption or delay in drug supply
could adversely affect the TLK286 development program. More detailed
information regarding factors that may cause actual results to differ
materially from the results expressed or implied by statements in
this press release may be found in Telik’s periodic filings
with the Securities and Exchange Commission. Telik assumes no obligation
to update any information in this press release.
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Contact:
Carol DeGuzman
Senior Director, Corporate Communications
Telik, Inc.
Tel 650-845-7728
Email cdeguzman@telik.com
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