Telik, Inc.
(Nasdaq: TELK), announced it has initiated two Phase 2 TELINTRA(R)
studies -- one with TELINTRA tablets in myelodysplastic syndrome, or MDS,
and a second with TELINTRA tablets in cancer patients at risk for
chemotherapy-induced neutropenia, or CIN.
As previously reported, Telik completed a successful 65 patient Phase 2
study with the IV formulation of TELINTRA in MDS, and a dose-escalating
Phase 1 study of the oral formulation of TELINTRA tablets in 45 patients.
The data from the multicenter Phase 1 study was presented at the December
2007 meeting of the American Society of Hematology and the positive results
support the initiation of these new Phase 2 clinical trials.
The randomized Phase 2 study with TELINTRA tablets in MDS is expected
to enroll 86 patients, with an anticipated 20 sites participating in the
study. Two dose schedules of TELINTRA tablets will be evaluated in
low-to-intermediate one risk MDS patients. The primary objective of the
study is to determine the hematologic improvement rate in erythroid or red
blood cell precursors in each treatment group as assessed by the
International Working Group criteria.
One group of patients will be given a starting dose of 4500mg of
TELINTRA daily in divided doses for two weeks followed by one week off
therapy. The second group of patients will receive the same dose of
TELINTRA for three weeks followed by one week off therapy. Patients will
receive treatment for up to six months, and if patients are continuing to
receive clinical benefit after this initial period, the treatment may be
extended for an additional six months with continuous daily dosing.
The second randomized Phase 2 study with TELINTRA tablets will be
conducted in non-small cell lung cancer patients who are being treated with
standard front line combination chemotherapy. This chemotherapy regimen is
often complicated by the toxicity of the drugs in suppressing the white
blood cell counts of these patients leaving them at higher risk for
infection. The current standard of care is the use of injectable
formulations of growth factors such as g-CSF (Neupogen(R), Neulasta(R)). A
randomized Phase 2 study with TELINTRA tablets in CIN is expected to enroll
135 patients and is expected to be conducted at 24 sites. One group of 90
patients will receive chemotherapy followed the next day by a starting dose
of 4500mg of TELINTRA per day in twice daily divided doses until white
blood cell count recovery. Another group of 45 patients will be the
chemotherapy-alone control group, which will receive standard supportive
care following chemotherapy. The study's objective is to evaluate the
effect of oral TELINTRA on accelerating hematologic recovery from
chemotherapy.
About Telik
Telik, Inc. of Palo Alto, CA, is a biopharmaceutical company focused on
discovering, developing and commercializing novel small molecule drugs to
treat serious diseases. The company's most advanced investigational drug
candidates in clinical development are TELINTRA, a modified glutathione
analog for the treatment of cytopenias due to myelodysplastic syndrome or
chemotherapy, and TELCYTA(R), a tumor-activated prodrug for the treatment
of advanced ovarian cancer and non-small cell lung cancer. Telik's product
candidates were discovered using its proprietary drug discovery technology,
TRAP(R), which enables the rapid and efficient discovery of small molecule
drug candidates.
This press release contains "forward-looking" statements, including
statements regarding the future development of TELINTRA and TELCYTA. These
forward-looking statements are based upon Telik's current expectations.
There are important factors that could cause Telik's results to differ
materially from those indicated by these forward-looking statements,
including, among others, if clinical trials of TELINTRA or TELCYTA are
delayed or unsuccessful, Telik's business would suffer, if Telik's
competitors develop and market products that are more effective than its
product candidates, or obtain marketing approval before Telik does, Telik's
commercial opportunity will be reduced or eliminated, and if Telik does not
obtain regulatory approval to market products in the U.S. and foreign
countries, Telik will not be permitted to commercialize these product
candidates. 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, including the factors
described in the section entitled "Risk Factors" in its annual report on
Form 10-K for the year ended December 31, 2007. Telik does not undertake
any obligation to update forward-looking statements contained in this press
release.
TELIK, the Telik logo, TELINTRA, TELCYTA, and TRAP are trademarks or
registered trademarks of Telik, Inc
Telik, Inc.
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