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Palo Alto, CA, - October 29, 2003 — Telik, Inc. (Nasdaq:
TELK) reported a net loss of $13.1 million, or $0.37 per share,
for the three months ended September 30, 2003, compared with a net
loss of $7.8 million, or $0.28 per share, for the comparable period
in 2002. The increase in the company’s net loss for the three
months ended September 30, 2003 was due primarily to increases in
research and development spending.
Research and development expenses were $10.7 million for the three
months ended September 30, 2003, compared with $6.7 million for
the comparable period in 2002. The increase in research and development
expenses reflects the expansion of the TELCYTA™ (TLK286) clinical
development program, including the ongoing Phase 3 registration
trial in ovarian cancer and ongoing Phase 2 trials in non-small
cell lung, breast and ovarian cancer.
Telik’s net loss for the nine months ended September 30,
2003 was $36.1 million, or $1.01 per share, compared with $22.1
million, or $0.79 per share, for comparable period in 2002. Research
and development expenses in the first three quarters of 2003 were
$30.7 million, compared to $19.0 million for the same period in
2002.
At September 30, 2003, Telik had $69.1 million in cash, cash equivalents
and investments including restricted investments, compared to $104.3
million at December 31, 2002.
Recent highlights have included:
- The Phase 3 clinical trial protocol for TELCYTA™ in advanced
non-small cell lung cancer (NSCLC) has successfully completed
Special Protocol Assessment (SPA) review by the U.S. Food and
Drug Administration. The protocol for the ongoing Phase 3 TELCYTA™
trial in platinum refractory or resistant ovarian cancer previously
underwent successful SPA review.
- Telik received FDA Fast Track designation for TELCYTA™
for third-line treatment in patients with platinum refractory
or resistant ovarian cancer.
- At the Tenth World Conference on Lung Cancer, Telik reported
maturing results from a Phase 2 trial of TELCYTA™ in advanced
non-small cell lung cancer, demonstrating an 11% objective response
rate and 69% overall disease stabilization rate.
- Telik reported interim data from three Phase 1-2a clinical trials
in which TELCYTA™ was used in combination with standard
chemotherapy drugs. Results indicate that the combinations were
well tolerated at all doses tested. In the carboplatin combination
trial in heavily pretreated, third-line or greater patients who
had failed a platinum-containing regimen, five of eight evaluable
patients (63%) had objective tumor responses by the RECIST criteria,
including one complete response, and an 88% overall disease stabilization
rate was observed. In the docetaxel combination trial in second
and third-line non-small cell lung cancer patients, three of 14
evaluable patients (21%) who received full doses of TELCYTA™
and docetaxel had objective tumor responses by the RECIST criteria,
and the overall disease stabilization rate was 64%. In combination
with Doxil®, the combination resulted in a 33% objective
response rate by the RECIST criteria and 100% disease stabilization
rate among the three evaluable ovarian cancer patients treated
with the highest dose of each drug.
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™ (TLK286), a tumor-activated small molecule product
candidate that is in a Phase 3 registration trial in advanced ovarian
cancer and in Phase 2 clinical trials in ovarian, non-small cell
lung and breast cancer. Telik’s product candidates were discovered
using its proprietary drug discovery technology, TRAP, which enables
the rapid and efficient discovery of small molecule drug candidates.
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) or TELINTRA™ (TLK199) 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, 2002 and our most recent
Quarterly Report on Form 10-Q for the quarter ended June 30, 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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