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Palo Alto, CA, June 5, 2004 — Telik, Inc. (Nasdaq:
TELK) reported positive results from a Phase 2 clinical trial using
the combination of TELCYTA™ (TLK286) and carboplatin. The
combination demonstrated a 56% objective response rate by RECIST
in patients with platinum refractory or resistant ovarian cancer,
including 3 patients with complete responses. The overall disease
control rate was 88%. The results were presented at the 40th annual
meeting of the American Society of Clinical Oncology today in New
Orleans.
Twenty-one patients were enrolled in the Phase 2 trial. Sixteen
patients were evaluable for efficacy; five patients were too early
to evaluate.
“The high objective response rate seen in this platinum
refractory-resistant patient group suggests that TELCYTA™
has the potential to re-sensitize platinum refractory or resistant
ovarian cancer to platinum, and confirms the single agent activity
of TELCYTA™ observed in previous Phase 2 studies without new
or unanticipated toxicities,” said Gail L. Brown, M.D., senior
vice president and chief medical officer. In the evidence-based
medical literature, response rates to platinum as well as other
second line agents of approximately 10% have been reported in ovarian
cancer patients with platinum refractory or resistant disease.1,2,3
“This trial provides a strong foundation for a randomized
Phase 3 trial, which we plan to initiate later this year,”
said Dr. Brown. “These data also support the further evaluation
of the TELCYTA-carboplatin combination in first-line non-small cell
lung and other cancers treated with platinum-based chemotherapy.”
Telik plans to initiate a multicenter Phase 3 randomized trial
of approximately 200 patients with second-line platinum refractory
or resistant ovarian cancer. The patients will be randomized to
receive either the combination of TELCYTA plus carboplatin or a
single agent currently approved for the treatment of ovarian cancer
in the second line. This trial is in addition to the ongoing Phase
3 trials evaluating TELCYTA as a single agent in platinum-resistant
ovarian and non-small cell lung cancer.
About Ovarian Cancer and TELCYTA
Approximately 25,580 new cases of ovarian cancer will be diagnosed
in 2004, according to the American Cancer Society. Ovarian cancer
causes more deaths than any other cancer of the female reproductive
system.
TELCYTA is currently in Phase 3 registration trials in ovarian
and non-small cell lung cancer (NSCLC), and it has been successfully
tested in Phase 2 trials in ovarian, NSCLC, breast and colorectal
cancer. This small molecule drug is activated by GST P1-1, an enzyme
present in cancer cells. Upon activation, an intracellular process
known as apoptosis, or programmed cell death, occurs. TELCYTA was
discovered through the application of Telik’s proprietary
drug discovery technology, TRAP.
About Telik
Telik, Inc. of Palo Alto, CA is a biopharmaceutical company working
to discover, develop and commercialize innovative small molecule
drugs to treat serious diseases. Additional information is available
at www.telik.com.
This press release contains “forward-looking” statements.
For this purpose, any statements contained in this press release
that are not statements of historical fact may be deemed to be forward-looking
statements, including any statements regarding the potential for
TELCYTA™ (TLK286) to treat one or more types of cancer. There
are a number of important factors that could cause Telik's results
to differ materially from those indicated by these forward-looking
statements, including, among others, the following: none of Telik’s
product candidates, including TELCYTA™, has been determined
to be safe or effective in humans or received regulatory approval
for marketing; it may take us several years to complete clinical
trials of our product candidates, including TELCYTA™, prior
to seeking regulatory approval for any indication; success in preclinical
testing and early clinical trials does not ensure that later clinical
trials will be successful, and interim results of clinical trials
do not necessarily predict final results; if our competitors develop
and market products that are more effective than our product candidates,
or obtain regulatory approval before we do, our commercial opportunity
will be reduced or eliminated; if we do not obtain regulatory approval
to market products in the United States and foreign countries, we
will not be permitted to commercialize our product candidates; if
we are unable to contract with third parties to manufacture our
product candidates in sufficient quantities and at an acceptable
cost, clinical development of product candidates could be delayed;
and if we are unable to raise adequate funds in the future, we will
not be able to continue to fund our operations and clinical trials
to develop our product candidates. These and other risks are detailed
from time to time in our SEC filings. Telik does not undertake any
obligation to update forward-looking statements.
References:
(1) Blackledge et al. Br J Cancer 59, 1989
(2) Gore et al. Gynecol Oncol 36, 1990
(3) Markman et al. JCO 9, 1991
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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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