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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 Doxil®.
The combination was well tolerated at the full dose of each drug,
and resulted in a 33% objective response rate and a 100% disease
stabilization rate in patients with platinum refractory or resistant
ovarian cancer in the second to fifth-line treatment setting. The
interim results were presented at the AACR-NCI-EORTC* Molecular
Targets and Cancer Therapeutics Conference in Boston.
Seventeen patients have been enrolled in the trial and 12 patients
were evaluable for efficacy. Five patients were too early to evaluate.
The patients had multiple poor prognostic indicators: refractory
or resistant to platinum-based chemotherapy (100%) and refractory
or resistant to paclitaxel (69%). Patients had failed a median of
2 prior treatment regimens (range 1 — 4), and 23% had bulky
disease, also a poor prognostic indicator.
All of the patients were alive at the time of interim analysis.
Among the three patients treated at full dose (TELCYTA™ 960
mg/m2 and Doxil 50 mg/ m2), one has a partial response (33%) by
the RECIST criteria and two have disease stabilization, for an overall
disease stabilization rate of 100%. In addition, all of the patients
treated at the lower doses have stable disease, providing early
evidence of synergy and a dose response to escalating doses of TELCYTA™
with Doxil®. The longest duration of therapy is ten months
and continuing.
The combination of TELCYTA™ and Doxil® was well-tolerated.
Hematologic toxicities observed with the combination were similar
to those observed with single agent Doxil®. No unexpected
or dose-limiting toxicities were reported. Patient enrollment continues
in the full dose cohort.
“These results suggest that TELCYTA™ and Doxil®
can be administered in a combination regimen with good tolerability
and evidence of dose-dependent efficacy,” said Gail L. Brown,
M.D., senior vice president and chief medical officer. “These
data support clinical trials utilizing the combination of TELCYTA™
and Doxil® in second line ovarian cancer and first line breast
cancer. Preclinical data presented at this meeting, demonstrating
that the TELCYTA™/Doxil® combination provides up to five
fold higher cancer cell cytotoxicity than the sum of the two drugs,
also support further clinical development of the combination.”
Case Report
A 64 year old female was diagnosed with ovarian cancer in 2002,
and underwent surgery to remove a large (25 pound) solid pelvic
mass and seven liters of ascites. She received platinum-based chemotherapy,
and in 2003 her tumor recurred. She began TELCYTA™ at 960
mg/m2 with Doxil 50 mg/m2 and after two cycles had a robust partial
response. Her CA125 declined from 80 at baseline to 20.7. She continues
to receive the full doses of the combination and is tolerating therapy
well.
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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