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Palo Alto, CA, September 3, 2003 — Telik, Inc. (Nasdaq:
TELK) announced that the U.S. Food and Drug Administration has granted
Fast Track designation for TELCYTA™ (TLK286) for third line
therapy in patients with platinum refractory or resistant ovarian
cancer.
“Fast Track designation is a recognition by the FDA of the
serious unmet medical need faced by women with platinum refractory
or resistant ovarian cancer, and the potential of TELCYTA™
to address that need,” said Gail L. Brown, M.D., senior vice
president and chief medical officer. A randomized Phase 3 registration
clinical trial with TELCYTA™ is in progress for third line
therapy in patients with platinum refractory or resistant ovarian
cancer.
Fast Track programs are designed to facilitate the development
and expedite the review of new drugs that are intended to treat
serious or life-threatening conditions and that demonstrate the
potential to address unmet medical needs.
About Ovarian Cancer and TELCYTA™
Approximately 25,400 new cases of ovarian cancer will be diagnosed
in 2003, according to the American Cancer Society. Ovarian cancer
causes more deaths than any other cancer of the female reproductive
system.
TELCYTA™ 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, an intracellular process
known as apoptosis, or programmed cell death, is initiated. TELCYTA™,
which has been evaluated in clinical trials in more than 400 patients,
was discovered through the application of Telik’s proprietary
drug discovery technology, TRAP. Telik has retained worldwide commercialization
rights.
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
TELCYTA™, in a Phase 3 registration trial in advanced ovarian
cancer, and in Phase 2 clinical trials in ovarian, non-small cell
lung and breast 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 our ability to
successfully develop TELCYTA™ for the treatment of any cancer,
its tolerability, potential efficacy or market potential. Telik
can give no assurance with regard to these statements. None of our
products have been determined to be safe or effective in humans
or been approved for marketing. Substantial additional testing,
including randomized, controlled clinical trials of TELCYTA™
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 approval will be obtained.
In addition, we are reliant on external manufacturing, and any interruption
or delay in drug supply could adversely affect the 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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