>>Infinity and MedImmune Initiate Phase 2 Clinical Trial of IPI-504, a Novel Hsp90 Inhibitor, in Patients With Advanced Hormone-Refractory Prostate Cancer
Tuesday November 13, 8:17 am ET
IPI-504 in Clinical Development for Three Solid Tumor Cancers
CAMBRIDGE, Mass. and GAITHERSBURG, Md., Nov. 13, 2007 (PRIME NEWSWIRE) -- Infinity Pharmaceuticals, Inc. (NasdaqGM:INFI - News) and MedImmune, Inc. today announced that the companies have initiated a Phase 2 clinical trial of IPI-504, their lead heat shock protein 90 (Hsp90) inhibitor, in patients with advanced hormone-refractory prostate cancer (HRPC). Enrollment has commenced at San Bernardino Urological Associates Medical Group in San Bernardino, Calif., and the study is expected to expand to additional sites including the Dana-Farber Cancer Institute (DFCI), the Massachusetts General Hospital, and the Beth-Israel Deaconess Medical Center in Boston, Mass. This study marks the third solid tumor indication in which IPI-504 is being evaluated.
``Hormone-refractory prostate cancer is a deadly disease with few effective therapeutic options for patients, particularly after docetaxel-based chemotherapy,'' said William Oh, M.D., clinical director, Lank Center for Genitourinary Oncology, DFCI, and the trial's principal investigator. ``This trial is an important opportunity to assess the impact that IPI-504 may have on delaying disease progression for patients with HRPC.''
The goal of this open-label, multi-center study is to determine the anti-tumor activity of IPI-504 in patients with HRPC, also referred to as castration-resistant prostate cancer, and to correlate prior treatment status with clinical response. Two groups of patients will be enrolled: one group having no prior treatment with cytotoxic chemotherapy, and one group having had prior treatment with a Taxotere(r) (docetaxel)-based chemotherapy. In this study, IPI-504 will be administered by intravenous infusion at the recommended Phase 2 dose of 400 mg/m2 on a three-week cycle of therapy, consisting of twice weekly treatment for two weeks followed by one week off. Evidence of biological activity in both groups of patients will be evaluated by RECIST (Response Evaluation Criteria in Solid Tumors) and measurement of prostate-specific antigen (PSA) levels. The trial is expected to enroll 30 patients initially (15 per group) and will expand to enroll an additional 10 patients in each trial arm if a response is observed in at least one patient in that arm.
Several proteins are believed to be important in the progression of HRPC, including the androgen receptor, Akt and Her-2. All of these are client proteins of Hsp90. Data from preclinical studies of IPI-504 in prostate cancer xenograft models indicate that Hsp90 inhibition may cause a dose-dependent degradation of these client proteins and growth inhibition of tumors.
``Initiating this trial in HRPC is an important milestone in our Hsp90 program. We now have three ongoing clinical trials evaluating IPI-504, in patients with gastrointestinal stromal tumors, non-small cell lung cancer, and prostate cancer, all of which are diseases where Hsp90 inhibition has a strong scientific rationale and there is a high unmet medical need for patients,'' said David Grayzel, M.D., vice president, clinical development and medical affairs, Infinity. ``Based on the safety and biological activity demonstrated by IPI-504 to date, we are enthusiastic about our anticipated expansion into the investigation of additional clinical indications.''
IPI-504 is currently being evaluated in the expansion phase of an ongoing Phase 1 trial in patients with metastatic gastrointestinal stromal tumors and soft tissue sarcomas and in an ongoing Phase 1/2 trial in patients with advanced non-small cell lung cancer.<<
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