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Palo Alto, CA, October 1, 2003 — Telik, Inc. (Nasdaq:
TELK) announced that the Phase 3 protocol for TELCYTA™ (TLK286)
in non-small cell lung cancer (NSCLC) has successfully completed
Special Protocol Assessment (SPA) review by the U.S. Food and Drug
Administration.
The trial, designated ASSIST-2 (Assessment of Survival
In Solid Tumors-2), will enroll approximately
500 patients with platinum refractory or resistant NSCLC who will
be randomized to receive either TELCYTA™ or Iressa®
(gefitinib) for the third-line treatment of NSCLC. The study is
designed to evaluate whether TELCYTA™ treatment leads to an
increase in survival as compared to the control treatment. The first
Phase 3 TELCYTA™ protocol, for the ongoing ASSIST-1
trial of TELCYTA™ in women with platinum refractory or resistant
ovarian cancer, previously underwent successful SPA review.
About Non-Small Cell Lung Cancer and TELCYTA™
Lung cancer results in 28% of all cancer deaths in the U.S., and
it is the leading cause of cancer deaths, according to the American
Cancer Society (ACS). The ACS estimates that 171,900 new cases of
lung cancer, most of the non-small cell type, will be diagnosed
in 2003, and an estimated 157,200 deaths will result from the disease.
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.
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™. 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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