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Palo Alto , CA , - December 5, 2004 – Telik, Inc. (Nasdaq: TELK) reported positive interim data from a Phase 2 trial of its TELINTRA™ (TLK199) drug candidate in myelodysplastic syndrome (MDS). The data were reported in two presentations at the annual meeting of the American Society of Hematology in San Diego .
Hematologic Improvement Following Treatment with TLK199 (TELINTRA™), a Novel Glutathione Analog Inhibitor of GST P1-1, in Myelodysplastic Syndrome: Interim Results of a Phase 2 Study (Abstract # 1428, Saturday, December 4, 2004 ):
A multicenter Phase 2 trial is ongoing to evaluate the safety and efficacy of TELINTRA in MDS patients. At the time of analysis, 34 MDS patients were evaluable for safety and 26 were evaluable for efficacy. Sixteen patients (61.5%) had clinically significant improvement in one or more blood cell lineages (red cells, white cells or platelets).
Clinically significant improvement was observed across all major MDS FAB subtypes (RA, RAEB, RAEB-t and RARS) and in all blood cell lineages. Using the International Working Group (IWG) MDS response criteria, 8 of 17 patients with red blood cell dysfunction had Hematologic Improvement – Erythrocytes (HI-E); 8 of 17 patients (47%) with white cell dysfunction had Hematologic Improvement – Neutrophils (HI-N); and 6 of 17 patients (35%) with platelet dysfunction had Hematologic Improvement – Platelets (HI-P).
Three of 12 patients (25%) had trilineage improvement and four of 19 patients (21%) had bilineage improvement, meeting the IWG MDS objective response criteria for overall Hematologic Improvement (HI). Clinical responses were associated with decreased red blood cell, platelet and growth factor support requirements, in some cases leading to transfusion independence.
TELINTRA was well-tolerated in this predominantly elderly patient population (median age 74 years). Enrollment in the Phase 2 trial is continuing to evaluate alternative dose schedules.
TLK199 (TELINTRA™), a Novel Glutathione Inhibitor of GST P1-1, Causes Proliferation and Maturation of Bone Marrow Precursor Cells and Correlates with Clinical Improvement in Myelodysplastic Syndrome Patients in a Phase 2 Study (Abstract # 2372, Sunday, December 5, 2004):
Telik scientists and academic collaborators reported translational data from the ongoing clinical trial demonstrating that TELINTRA stimulates the formation of bone marrow cells that are precursors to granulocytes and monocytes (white blood cells), erythrocytes (red blood cells) and platelets in MDS patients with abnormally low blood cell counts. These results correlated with clinical improvement.
About TELINTRA and MDS
TELINTRA is a novel small molecule that has been shown in preclinical testing to have myelorestorative activity in vitro and in vivo, when administered orally or by injection. It was discovered using Telik’s proprietary TRAP small molecule drug discovery technology.
The myelodysplastic syndromes are a group of disorders characterized by the abnormal formation, development and maturation of blood elements. They are associated with a variable incidence of transformation to acute leukemia. The incidence and prevalence of MDS appears to be increasing, perhaps in part due to the aging of the population.
About Telik, Inc.
Telik, Inc. of Palo Alto , CA is a biopharmaceutical company dedicated to discovering, developing and commercializing small molecule drugs to treat cancer and other serious diseases. The company’s most advanced drug development candidate is TELCYTA™ (TLK286), a cancer cell-activated small molecule product candidate that is in Phase 3 registration trials in advanced ovarian and non-small cell lung 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 TELINTRA (TLK199) to treat myelodysplastic syndrome or chemotherapy-induced cytopenias. 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 TELINTRA, 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 TELINTRA, 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, including under the heading “Additional Factors that May Effect Future Results” in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2004 . 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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