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Palo Alto, CA, June 1, 2003 — Telik, Inc. (Nasdaq:
TELK) announced positive interim results from a second Phase 2 trial
which confirm the clinical activity of TELCYTA™ (TLK286) administered
as a single agent in the treatment of patients with non-small cell
lung cancer who have failed platinum-containing regimens. The data
were presented at the annual meeting of the American Society of
Clinical Oncology in Chicago.
Interim results from this trial show an 8% objective response rate
(one partial response by the RECIST criteria), one minor response
(8%) and a 67% overall disease stabilization rate. Median duration
of stable disease is greater than 4.5 months and ongoing. Median
survival has not yet been reached. 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. Thirty-three patients with Stage
IIIB or IV non-small cell lung cancer were evaluable for survival
and 12 patients were evaluable for tumor response at the time of
interim analysis. Half had failed prior platinum therapy and two-thirds
also were resistant to paclitaxel.
“Advanced, chemotherapy-resistant non-small cell lung cancer
patients have a predictably poor prognosis, and published clinical
trials with second- and third-line agents for the disease have shown
low response rates and median survival times from four to six months,”
said Gail L. Brown, M.D., senior vice president and chief medical
officer. “In the earlier Phase 2 trial of TELCYTA™
in non-small cell lung cancer, median survival was significantly
improved over that expected for these patients. We are encouraged
that the objective responses and high disease stabilization rate
may translate to a survival advantage in this ongoing trial.”
Telik plans to initiate a registration Phase 3 trial of TELCYTA™
for the treatment of advanced non-small cell lung cancer.
In Phase 2 trials, TELCYTA™ has demonstrated clinical activity
in ovarian, breast and colorectal cancer, in addition to non-small
cell lung cancer. A high proportion of these tumors express GST P1-1, which activates TELCYTA™ within the tumor.
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. 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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