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Palo Alto, CA — June 30, 2004 — Telik, Inc.
(Nasdaq: TELK) announced the initiation of a new Phase 2 clinical
trial in which TELCYTA™ (TLK286) will be evaluated in combination
with carboplatin and paclitaxel in the front-line treatment of Stage
IIIb or IV non-small cell lung cancer (NSCLC). The trial is expected
to enroll approximately 50 NSCLC patients who have not previously
received chemotherapy. Platinum and taxane-based drug combinations
are the current standard for the front-line chemotherapy of lung
cancer.
The trial is being conducted at teaching affiliates of the Harvard
Medical School including the Dana-Farber Cancer Institute, Massachusetts
General Hospital and Beth Israel Deaconess Medical Center. Thomas
Lynch, M.D., Medical Director, Center for Thoracic Cancers, Massachusetts
General Hospital and Associate Professor of Medicine, Harvard Medical
School, is Principal Investigator of the study.
“There is a great need for new and effective therapies applicable
across the entire range of advanced non-small cell lung cancer types,”
said Dr. Lynch. “We look forward to conducting this study
incorporating TELCYTA, which has shown promising results in non-small
cell lung cancer, into our standard front-line chemotherapy regimen.”
The initiation of this trial follows positive data reported from
two Phase 2 trials of single agent TELCYTA in platinum-resistant
NSCLC, and two recently reported Phase 2 trials using TELCYTA in
combination with docetaxel and carboplatin. In the TELCYTA plus
docetaxel trial in platinum-resistant NSCLC, a 27% objective response
rate by RECIST was reported, including one complete response and
7 partial responses; the disease control rate was 67%. In the TELCYTA
plus carboplatin trial in platinum refractory or resistant ovarian
cancer, the objective response rate by RECIST was 56%, including
three complete responses (19%) and six partial responses (38%);
the disease control rate was 88%. The augmented response rates compared
to expected with the standard drugs were not accompanied by increased
toxicities in these trials. The combination data were reported at
the recent annual meeting of the American Society of Clinical Oncology.
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, representing approximately
28% of all cancer deaths in the U.S.
TELCYTA is currently in Phase 3 registration trials in NSCLC (www.assist-2trial.com)
and ovarian cancer (www.assist-1trial.com), and it has been successfully
tested in Phase 2 trials in NSCLC, ovarian, 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.
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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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