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Palo Alto, CA, - March 30, 2004 — Telik, Inc. (Nasdaq:
TELK) announced the initiation of a randomized Phase 3 registration
trial of TELCYTA™ (TLK286) administered as a single agent
in non-small cell lung cancer (NSCLC) patients who have failed two
prior chemotherapy regimens.
The multinational trial, designated ASSIST-2 (ASsessment
of Survival In Solid Tumors-2),
is expected to enroll approximately 520 patients who are being randomized
to TELCYTA™ treatment or to a control group receiving Iressa®,
the approved third-line treatment for NSCLC. The study is designed
to evaluate whether TELCYTA™ treatment reduces the risk of
death, leading to an increase in survival, as compared to the control
group treatment. Additional endpoints include time to tumor progression
and objective response rate.
“Patients with advanced, refractory non-small cell lung
cancer have a poor prognosis and limited treatment alternatives,”
said Gail L. Brown, M.D., senior vice president and chief medical
officer. “TELCYTA’s novel mechanism of targeted activation,
and the efficacy and safety results observed in multiple Phase 2
trials, provide a strong rationale for this registration trial.”
Telik is also conducting the ASSIST-1 trial, a multinational Phase
3 registration trial of TELCYTA™ in women with resistant ovarian
cancer. Patients and caregivers seeking information about this clinical
trial may visit www.assist1-trial.com.Additional clinical trials
are ongoing using TELCYTA™ in combination treatment regimens
in NSCLC and ovarian cancer, and as a single agent in previously
untreated metastatic breast cancer. Click
here for further information on TELCYTA™ clinical trials.
The protocols for the TELCYTA™ Phase 3 trials in NSCLC and
ovarian cancer have been reviewed through the FDA Special Protocol
Assessment process, and the FDA has granted Fast Track designation
for both indications.
About TELCYTA™
TELCYTA™ is a small molecule tumor-activated drug which is
activated by 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, occurs. TELCYTA™,
which has been successfully evaluated in Phase 2 clinical trials
in ovarian, NSCLC, breast and colorectal cancer, 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 reports, including our Annual Report
on Form 10-K for the year ended December 31, 2003. Telik does not
undertake any obligation to update forward-looking statements.
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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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