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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 docetaxel in patients
with platinum-resistant non-small cell lung cancer (NSCLC). The
combination demonstrated a 27% objective response rate by RECIST
with one complete response and seven partial responses. The overall
disease control rate was 67%. The results were presented today at
the 40th annual meeting of the American Society of Clinical Oncology
in New Orleans.
Thirty-seven patients were enrolled and thirty patients were evaluable
for efficacy. All of the patients had failed or progressed on prior
platinum-based chemotherapy. One-third of the patients had failed
treatment with EGFR inhibitors.
“The results of this trial, demonstrating a 27% objective
response rate, are significant given that the objective response
rate reported in the evidence-based medical literature with docetaxel
as a single agent in the second line setting in platinum-resistant
non-small cell lung cancer is 5 to 9%1,2,3, and confirm the single
agent activity of TELCYTA™,” said Gail L. Brown, M.D.,
senior vice president and chief medical officer. “These data
demonstrate that the combination of TELCYTA™ and docetaxel
may provide significant clinical benefit with durable responses
without new or unanticipated toxicities. In addition, these results
support additional clinical trials using the TELCYTA™/docetaxel
combination in the first and second line non-small cell lung cancer
treatment.”
About Non-Small Cell Lung Cancer and TELCYTA™
Lung cancer is the leading cause of cancer deaths, according to
the American Cancer Society (ACS). The ACS estimates that 173,770
new cases of lung cancer will be diagnosed in 2004 and an estimated
160,440 deaths will result from the disease.
TELCYTA is currently in Phase 3 registration trials in NSCLC and
ovarian cancer, 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) Shepherd et al. JCO 18:10, 2000
(2) Fossella et al. JCO 18:12, 2000
(3) Hanna et al. JCO 22:9, 2004
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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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