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Palo Alto, CA, June 2, 2003 — Telik, Inc. (Nasdaq:
TELK) announced positive interim results from the first Phase 2
study of TELCYTA™ (TLK286) in the treatment of women with
advanced metastatic breast cancer. The data were presented at the
annual meeting of the American Society of Clinical Oncology in Chicago.
There was a 15% objective response rate (one complete response
and two partial responses by RECIST criteria), and a 35% overall
disease stabilization rate in this poor prognosis patient group.
Median duration of stable disease is greater than 4 months and ongoing.
TELCYTA™ continues to be well-tolerated, with the most common
adverse events in this trial categorized as Grade 1 or 2 (mild to
moderate). There were few Grade 3 and no Grade 4 adverse events.
The interim analysis is based on 40 women with Stage IV metastatic
breast cancer, 20 of whom were evaluable for tumor response at the
time of interim analysis. All of the patients had failed two or
more prior therapies including anthracyclines and taxanes. Most
of the patients have disease that had metastasized to two or more
organ systems.
“We have for the first time demonstrated responses to TELCYTA™
in advanced metastatic breast cancer, in women who have exhausted
essentially all treatment alternatives,” said Gail L. Brown,
M.D., senior vice president and chief medical officer. “The
interim results of this trial, including objective complete and
partial responses, support further testing of TELCYTA™ in
advanced breast cancer, a very difficult to treat cancer, as a single
agent as well as in combination regimens in less advanced patients.”
In Phase 2 trials, TELCYTA™ has demonstrated clinical activity
in ovarian, non-small cell lung and colorectal cancer, in addition
to breast cancer. A high proportion of these tumors express GST P1-1, which activates TELCYTA™ within the tumor.
About Advanced Metastatic Breast Cancer and
TELCYTA™
Breast cancer is the most common malignancy, and the second most
common cause of cancer-related deaths, in women. In 2003, approximately
211,300 new cases of breast cancer will be diagnosed and 40,200
people will die from the disease, according to the American Cancer
Society.
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 370 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 earlier stage 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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