Infinity to begin phase 3 trial of cancer drug
May 31st, 2008 | by admin |NEW YORK, May 31 (Reuters) - Infinity Pharmaceuticals Inc(INFI.O: Quote, Profile, Research) said on Saturday it plans to begin late-stage testingof its experimental cancer drug for gastrointestinal stromaltumors (GIST) that have failed to respond to other treatments.
The phase 3 placebo-controlled trial of IPI-504 is expectedto include 200 patients with GIST whose tumors have growndespite treatment with Novartis’ (NOVN.VX: Quote, Profile, Research) Gleevec or PfizerInc’s (PFE.N: Quote, Profile, Research) Sutent, or who were unable to take those drugs.
Infinity, which is co-developing the drug with AstraZenecaPlc (AZN.L: Quote, Profile, Research), made the announcement at the American Society ofClinical Oncology meeting in Chicago in conjunction the releaseof some early stage data on the drug.
GIST is a type of sarcoma of the digestive system, usuallyfound in the wall of the stomach.
Infinity said the U.S. Food and Drug Administration hadsigned off on the design of the pivotal trial. Phase 3 istypically the final stage of human testing before seeking anapproval decision from health regulators.
The primary goal of the study will be progression freesurvival. Secondary goals will include disease control rate,time to progression, and overall survival, the company said.
There is no limit on the number of prior therapies patientsmay have received before entering the study.
Analyses of data are expected to occur within about twoyears of the first patient being enrolled, Infinity said.
“This Phase 3 study provides a definitive path fordelivering on the potential of IPI-504 in the treatment ofrefractory GIST,” David Grayzel, Infinity’s head of clinicaldevelopment and medical affairs, said in a statement. (Reporting by Bill Berkrot; Editing by Tim Dobbyn)
