Infinity and MedImmune Initiate Phase 2 Trial of IPI-504 to Assess the Hsp90 Inhibitor's Potential Anti-Tumor Activity in Patients With Advanced Non-Small Cell Lung Cancer
Wednesday December 19, 12:02 pm ET
CAMBRIDGE, Mass. and GAITHERSBURG, Md., Dec. 19, 2007 (PRIME NEWSWIRE) -- Infinity Pharmaceuticals, Inc. (NasdaqGM:INFI - News) and MedImmune, Inc. today announced that the companies have initiated the Phase 2 portion of a Phase 1/2 clinical trial of IPI-504, their lead heat shock protein 90 (Hsp90) inhibitor, in patients with advanced non-small cell lung cancer (NSCLC). Enrollment has commenced at the Mount Sinai Comprehensive Cancer Center in Miami, Fla. and Yale Cancer Center in New Haven, Conn. and the study is expected to expand to additional sites throughout North America.
``The initiation of this study is another important milestone for our Hsp90 inhibitor program,'' said David Grayzel, M.D., vice president, clinical development and medical affairs, Infinity. ``We are encouraged by the evidence of biological activity we saw in the Phase 1 portion of the study and are eager to further evaluate IPI-504 in Phase 2. Non-small cell lung cancer is an aggressive disease and we are grateful to the patients, their families, and the outstanding caregivers collaborating with us in order to develop potential new treatment options.''
The goal of this open-label, multi-center clinical trial is to evaluate the anti-tumor activity of IPI-504 in patients with NSCLC. Initially, the Phase 2 portion of the study will enroll a total of 20 patients in two equal groups: one group with known epidermal growth factor receptor (EGFR) mutations and one group with wild-type EGFR. Evidence of anti-tumor activity will be evaluated using RECIST criteria (Response Evaluation Criteria in Solid Tumors). If sufficient evidence of clinical benefit is observed in either cohort, 19 additional patients will be enrolled in that cohort. IPI-504 is being administered intravenously at 400 mg/m2 on a three-week cycle, consisting of twice-weekly treatment for two weeks followed by one week off treatment.
Preliminary results of the Phase 1 portion of the Phase 1/2 study were presented in November 2007 at the American Association for Cancer Research-National Cancer Institute-European Organization for Research and Treatment of Cancer (EORTC) International Conference on Molecular Targets and Cancer Therapeutics. As reported, seven of nine evaluable patients receiving IPI-504 achieved stable disease by RECIST over at least one cycle of administration. One patient with a mutation in EGFR and a prior history of disease progression on targeted kinase inhibitors satisfied one of the defined endpoints for expansion into the Phase 2 portion of the trial (stable disease greater than 12 weeks). Additionally, two of four evaluated patients who underwent positron emission tomography (PET) had partial responses by PET according to EORTC criteria. All four patients exhibited a decrease in tumor metabolic activity in response to IPI-504 administration as measured by PET.
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