Telik Announces Phase 1 Results Of A Multicenter Study Of Telintra® (Ezatiostat Hydrochloride, TLK199) In Combination With Revlimid® (Lenalidomide) In Patients With Myelodysplastic Syndrome
PALO ALTO, Calif., Dec. 13, 2011 /PRNewswire/ -- Telik, Inc. (Nasdaq: TELK) today announced positive results from a Phase 1 multicenter dose-ranging trial of the combination of Telintra and Revlimid in patients with International Prognostic System Score (IPSS) Low to Intermediate-1 Risk non-deletion (5q) myelodysplastic syndrome (MDS).
The majority of MDS patients are Low to Intermediate-1 Risk non-deletion (5q) and represent an important unmet medical need. Although Revlimid currently is not approved for the treatment of non-deletion (5q) MDS it is used in this setting because of limited alternatives. The rationale for the combination of Telintra and Revlimid is based on Telintra's novel mechanism of action, lack of suppression of white blood cell levels and the efficacy seen in single-agent Phase 1 and Phase 2 studies in the Low to Intermediate-1 Risk non-deletion (5q) MDS patient population.
The primary objective of the study was to establish the safety of the combination and the optimal dosing for Telintra in combination with the standard dose of Revlimid. The secondary objectives were to assess the efficacy as measured by rates of hematologic improvement in red blood cell, white blood cell and platelet levels, and decreases in blood transfusions, according to International Working Group criteria (IWG 2006).
Nineteen patients were treated at 9 investigational centers. Patients received Telintra at a starting dose of 2000 mg in combination with standard dose Revlimid (10 mg) on days 1-21 of a 28-day cycle. In stage 1, 3-6 patients in a standard 3+3 design were treated before escalation to the 2500 mg Telintra and 10 mg Revlimid dose levels. The optimal dose of the combination was 2000 mg Telintra and 10 mg of Revlimid. This cohort was expanded by an additional 10 patients in stage 2.The median age was 75 years, with 5 patients having IPSS Low Risk classification and 14 patients having Intermediate-1 Risk. Thirteen of 19 patients (68%) were red blood cell transfusion-dependent and required a median of 6 units of blood (range 4-10) during an 8 week period. Two patients were platelet transfusion-dependent and 4 additional patients (21%) had clinically-significant low platelet levels.
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