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Palo Alto, CA, June 1, 2003 — Telik, Inc. (Nasdaq:
TELK) announced positive interim results from a second Phase 2 clinical
trial of TELCYTA™ (TLK286) administered as a single agent
in women with platinum refractory or resistant ovarian cancer, that
confirm the previous results of a previous Phase 2 trial in this
patient population. The data were presented at the annual meeting
of the American Society of Clinical Oncology in Chicago.
The interim results show a 17% objective response rate (three partial
responses by RECIST criteria) and 56% overall disease stabilization
rate in women with advanced, platinum refractory or resistant ovarian
cancer. Responses were accompanied by clinical symptom improvement.
Median duration of stable disease is greater than six months and
ongoing. Median survival has not yet been reached. TELCYTA™
continues to be well-tolerated, with the most common adverse events
categorized as Grade 1 or 2 (mild to moderate). Grade 3 adverse
events were infrequent, and no Grade 4 adverse events were reported.
The interim analysis is based on 33 patients evaluable for survival
and 18 patients evaluable for tumor response. All of the patients
were either refractory or resistant to platinum, and 82% were resistant
to paclitaxel and additional salvage therapies.
“These results confirm the clinical activity reported in
the previous Phase 2 trial of TELCYTA™ in advanced ovarian
cancer and support the ongoing Phase 3 registration trial of TELCYTA™
in the third-line ovarian cancer setting,” said Gail L. Brown,
M.D., senior vice president and chief medical officer. “The
interim results of this trial are comparable with those of the first
ovarian cancer trial at a similar stage. This is encouraging because,
in our earlier Phase 2 trial, clinical responses correlated with
improved overall median survival. The efficacy, favorable toxicity
profile and non-overlapping toxicities reported with TELCYTA™
now observed over a wide range of patient drug exposure, facilitate
its use both as a single agent and in combination regimens in less
advanced patients.”
“Further, we are pleased to report that the ovarian cancer
patient in our earlier Phase 2 trial, whose complete response following
TELCYTA™ treatment was first reported at the 2002 ASCO meeting,
remains in complete remission and off all treatment for ovarian
cancer,” Dr. Brown said. “This durable, long-term complete
response is particularly encouraging because her disease was refractory
to platinum therapy.”
In Phase 2 trials, TELCYTA™ has demonstrated clinical activity
in breast, non-small cell lung and colorectal cancer, in addition
to ovarian cancer. A high proportion of these tumors express GST P1-1, which activates TELCYTA™ within the tumor.
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
is the sixth most common cause of cancer-related deaths in the U.S.
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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