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Palo Alto, CA, November 19, 2003 — Telik, Inc. (Nasdaq:
TELK) reported that the combination of TELCYTA™ (TLK286) and
carboplatin was well tolerated and demonstrated a 63% objective
response rate and an 88% overall disease stabilization rate in advanced
patients with platinum refractory or resistant ovarian cancer treated
in the third to sixth line setting in a Phase 1-2a clinical trial.
The interim results were presented at the AACR-NCI-EORTC* Molecular
Targets and Cancer Therapeutics Conference in Boston.
At the time of interim analysis, 13 patients were enrolled in the
trial. Eight patients were evaluable for efficacy; five patients
were too early to evaluate. All of the patients were heavily pretreated,
having failed at least two prior chemotherapy regimens (median 3.5)
including platinum-based therapy. Fifty percent of the patients
had bulky disease, a poor prognostic indicator for ovarian cancer.
The patients evaluable for efficacy received TELCYTA™ at
500 mg/m2 (50% of the single agent dose) in combination with carboplatin
at AUC 5 or 6 once every four weeks. The combination was well-tolerated.
The hematologic toxicities seen with the combination of TELCYTA™
and carboplatin were similar to those seen with carboplatin alone.
No unexpected or dose-limiting toxicities were reported.
The 63% objective response rate and 88% disease stabilization rate
included one complete response and four partial responses by the
RECIST criteria, and two patients with stable disease. The longest
duration of therapy is ten months and ongoing. Dose escalation of
TELCYTA™ and patient enrollment is continuing.
“Platinum-based combination regimens are the standard of
care for the treatment of front-line ovarian and non-small cell
lung cancer,” said Gail L. Brown, M.D., senior vice president
and chief medical officer. “We have previously demonstrated
significant clinical activity of TELCYTA™ as a single agent
in the clinical setting of third line or greater platinum and taxane
refractory or resistant ovarian cancer. The observation of synergy
with TELCYTA™ and platinum in platinum resistant patients
who had progressed on all available therapies is a significant finding.
During this meeting, we also are presenting preclinical data demonstrating
synergy between TELCYTA™ and carboplatin. Together, these
data support the clinical testing of the combination of TELCYTA™
and carboplatin in the first and second line treatment setting for
ovarian, non-small cell lung and other cancer types treated with
platinum-based chemotherapy.”
Case Report
A 57 year old female was diagnosed with ovarian cancer in 1999.
She had disease progression after five different chemotherapy regimens,
including her most recent regimen of high dose carboplatin (AUC
11) with recombinant thrombopoietin and stem cell bone marrow transplant.
The patient was enrolled in the Phase 1-2a trial of TELCYTA™
in combination with carboplatin. She has had complete resolution
of tumors in her pelvis and liver, and her CA125 level declined
from 258.3 to 10.9. She continues in complete remission on combination
TELCYTA™/carboplatin treatment for six months and ongoing.
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
causes more deaths than any other cancer of the female reproductive
system.
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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