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Palo Alto, CA, November 19, 2003 — Telik, Inc.
(Nasdaq: TELK) reported positive interim results from a Phase 1-2a
clinical trial of the combination of TELCYTA™ (TLK286) and
docetaxel in patients with platinum resistant non-small cell lung
cancer (NSCLC). The combination was well tolerated at the full dose
of each drug, and resulted in a 29% objective response rate and
an overall 69% disease stabilization rate. The results were presented
at the AACR-NCI-EORTC* Molecular Targets and Cancer Therapeutics
Conference in Boston.
Forty-six NSCLC patients have been enrolled in the Phase 1-2a trial,
which is fully accrued. At interim analysis, 23 patients were evaluable
for safety and efficacy, including 17 patients treated at full dose
(TELCYTA™ 960 mg/m2 and docetaxel 75 mg/m2). All of the patients
had failed or progressed on prior platinum-based chemotherapy as
well as additional salvage regimens.
The combination was well-tolerated at all dose levels in the advanced
NSCLC patients. The hematologic toxicities seen were similar to
the toxicities seen with single agent docetaxel. There were no unexpected
or dose-limiting toxicities.
The 29% objective response rate and 69% disease stabilization rate
include five partial responses by the RECIST criteria and 6 patients
with stable disease. The longest duration of therapy is 8 months
and continuing. Disease stabilization also was observed at the lower
TELCYTA™ doses tested, providing early evidence for synergy
and a dose response to escalating doses of TELCYTA™ with docetaxel.
“Advanced platinum resistant non-small cell lung cancer
patients have a very poor prognosis and limited treatment alternatives,”
said Gail L. Brown, M.D., senior vice president and chief medical
officer. “These data indicate that the combination of TELCYTA™
and docetaxel may provide significant clinical benefit, as well
as support a clinical trial using the TELCYTA™/docetaxel combination
in the first and second line NSCLC setting. These clinical data
are also consistent with preclinical studies presented during this
meeting demonstrating that the combination of TELCYTA™ and
docetaxel produced greater inhibition of cancer cell growth than
the sum of both agents.”
Case Report
A 71 year old female was diagnosed with metastatic NSCLC in 2002.
She was treated with a platinum-containing regimen including pemetrexed
and had a partial response, and later relapsed. She began TELCYTA™
960 mg/m2 in combination with docetaxel 75 mg/m2. She has a robust
partial response to the combination, and continues to be treated
with good tolerability for 6 months and ongoing.
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 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 500 patients,
was discovered through the application of Telik’s proprietary
drug discovery technology, TRAP. Telik has retained worldwide commercialization
rights.
* American Association for Cancer Research — National
Cancer Institute — European Organization for Research and
Treatment of Cancer
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™. 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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