Telik Reports Positive Results From Phase 1 Dose-Escalation Study of TELINTRA
Tablets in Myelodysplastic Syndrome
PALO ALTO, Calif., Dec. 8 /PRNewswire-FirstCall/ -- Telik, Inc.
(Nasdaq: TELK) announced positive results from the multicenter Phase 1
dose-escalation study of TELINTRA(R) (ezatiostat HCl) Tablets in
myelodysplastic syndrome (MDS) that support the initiation of Phase 2 clinical
trials. The data were reported at the 49th annual meeting of the American
Society of Hematology in Atlanta.
The objectives of the trial were to evaluate the safety and
pharmacokinetics of TELINTRA Tablets (also known as TLK199 Tablets), and
obtain preliminary indications of efficacy (International Working Group, IWG,
2000 criteria). The trial enrolled 45 patients and included all WHO
classifications of MDS. Patients received one of ten dose levels of TELINTRA
Tablets taken daily for seven days followed by two weeks of follow-up.
Patients could receive planned therapy up to six months (eight cycles) until
MDS progression or unacceptable toxicity.
TELINTRA Tablets were well-tolerated and no dose-limiting toxicities were
observed. The most common non-hematologic toxicities were mild Grade 1 and 2
nausea, diarrhea and vomiting. Blood concentrations of the active metabolite
of TELINTRA Tablets increased with dose levels.
Thirty-nine patients were evaluable for efficacy by objective Hematologic
Improvement (HI) criteria. A dose-response curve was observed, with the
majority of responses occurring in patients treated at the higher dose levels.
Across all doses, neutrophil (HI-N) responses were observed in 21% (4 of 19)
patients with neutrophil cytopenias. Seven of 21 patients (33%) with platelet
cytopenias had HI-P. Among the 29 patients with erythroid cytopenias, HI-E
was observed in six patients (21%). Some patients achieved red blood cell
transfusion independence or a reduction in transfusion requirements, and one
patient achieved platelet transfusion independence. One patient had a complete
cytogenetic response.
"A tremendous need exists for new agents that are well-tolerated and
efficacious for the treatment of MDS patients," said Azra Raza, M.D.,
Professor of Medicine and Director - MDS Program at St. Vincent's
Comprehensive Cancer Center in New York City, and lead investigator on the
TELINTRA Tablets study. "Having treated MDS patients with the intravenous
formulation of TELINTRA, and now with the more convenient Tablet formulation,
I am hopeful that planned Phase 2 dose-ranging trials will continue to
demonstrate the potential for this agent to address early-stage MDS cytopenias
as an alternative to blood support and best supportive care."
About TELINTRA
TELINTRA is an investigational small molecule designed to stimulate the
production of blood cells in the bone marrow for the potential treatment of
cytopenias associated with MDS or chemotherapy. Telik has developed both
intravenous and Tablet formulations of TELINTRA, which was discovered through
the application of Telik's proprietary TRAP(TM) drug discovery technology.
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 drug development
candidates are TELCYTA(R), a tumor-activated small molecule product candidate
in clinical development for the treatment of advanced ovarian cancer and
non-small cell lung cancer; and TELINTRA(R), which is in development for the
treatment of cytopenias due to myelodysplastic syndrome or chemotherapy.
Telik's product candidates were discovered using its proprietary drug
discovery technology, TRAP(TM), 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, including
statements regarding Telik's future development plans for TELINTRA. 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 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 any product that Telik may
develop, 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 United States and foreign
countries, Telik will not be permitted to commercialize its 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 quarterly report on Form 10-Q for the
quarter ended September 30, 2007. Telik does not undertake any obligation to
update forward-looking statements contained in this press release.
TELIK, the Telik logo, TELCYTA, TELINTRA and TRAP are trademarks or
registered trademarks of Telik, Inc.
SOURCE Telik, Inc.
Carol D. DeGuzman, Senior Director, Corporate Communications, of Telik, Inc.,
+1-650-845-7728, cdeguzman@telik.com
