Key Developments For Infinity Pharmaceuticals, Inc.
Infinity Pharmaceuticals, Inc. (INFI.O) (Consolidated Issue listed on NASDAQ Global Market)
Infinity Pharmaceuticals Inc. Presents New Preclinical Data From Its Heat Shock Protein 90 Inhibitor Program
Infinity Pharmaceuticals Inc. presented data from its heat shock protein 90 (Hsp90) inhibitor program that supports the scientific rationale for Infinity's recently initiated Phase 2 study in breast cancer, and further enhances Infinity's scientific leadership in the field of Hsp90 inhibition. The data were presented during the 2009 American Association of Cancer Research (AACR) Annual Meeting in Denver. Infinity is developing two Hsp90 inhibitors: IPI-504, which is in Phase 2 clinical development, and its oral Hsp90 inhibitor, IPI-493, which is in Phase 1 clinical development. Over-expression of the protein HER2 predicts an aggressive type of breast cancer for which Herceptin (trastuzumab) is a primary treatment. Many patients, however, eventually develop resistance to Herceptin. In preclinical experiments, Infinity has shown that administration of IPI-504 results in the rapid degradation of HER2 in vitro, ultimately resulting in tumor cell growth inhibition and cell death. Preclinical data presented at AACR, in collaboration with researchers from Vall d'Hebron Institute of Oncology in Barcelona, Spain, now show that in Herceptin-resistant xenografts, HER2 protein levels were significantly reduced in vivo 12 hours after a single dose of IPI-504, and remained suppressed at 48 hours. Further, dose administration with IPI-504 in this model produced substantial tumor growth inhibition.
Infinity Pharmaceuticals Inc. Stops Cancer Drug Trial-Reuters
Reuters reported that Infinity Pharmaceuticals Inc. said it halted a late-stage study of its cancer drug for gastrointestinal stromal tumors (GIST), after an early review showed an higher-than-expected death rate among patients receiving the drug. The Independent Data Monitoring Committee on Tuesday recommended the trial be halted based on an early review of safety data from the first 46 patients enrolled in the study. No new patients will be enrolled in the trial, and patients currently enrolled in the study will no longer receive the experimental drug, IPI-504, Infinity said in a statement.
Infinity Pharmaceuticals Inc. Initiates International Phase 2 Trial of IPI-504 In Combination With Herceptin In Patients With HER2-Positive Breast Cancer
Infinity Pharmaceuticals Inc. announced the initiation of a Phase 2 clinical trial of IPI-504 (retaspimycin hydrochloride), its lead heat shock protein 90 (Hsp90) inhibitor, in combination with Herceptin (trastuzumab) in patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer. IPI-504 has demonstrated the potential to disrupt the activity of multiple proteins and cell signaling pathways implicated in tumor growth, including HER2, a key signaling pathway in breast cancer. The goal of this open-label, international, multi-center Phase 2 clinical trial is to evaluate the safety and anti-tumor activity of IPI-504 in combination with Herceptin in patients with pretreated, locally advanced or metastatic HER2-positive breast cancer. IPI-504 is being administered intravenously at 300 mg/m2 on a three-week cycle, consisting of twice-weekly treatment for two weeks followed by one week off treatment. Herceptin will be administered intravenously once every three weeks. Evidence of anti-tumor activity will be evaluated using RECIST criteria (Response Evaluation Criteria in Solid Tumors). The Phase 2 study will enroll a total of 46 patients and Infinity anticipates presenting preliminary data in mid-2010.
Infinity Pharmaceuticals Inc. Announces Hedgehog Pathway Preclinical Data in Ovarian Cancer
Infinity Pharmaceuticals Inc. announced the presentation of preclinical data from the natural product foundation of IPI-926, Infinity's orally-available inhibitor of the Hedgehog pathway, demonstrating significant inhibition of tumor growth in a primary ovarian cancer model. The data show that treatment with cyclopamine, the natural product foundation of IPI-926, in animals bearing grafts of primary ovarian cancer resulted in significant tumor growth inhibition compared to vehicle treated animals. Dr. Rueda's models of ovarian cancer are derived from patient specimens that have not undergone prior tissue culture, and are believed to reflect the clinical presentation of ovarian cancer. Infinity's oral, Hedgehog pathway inhibitor, IPI-926, is semi-synthetic derivative of the natural product cyclopamine with superior drug-like properties, including being 30 to 50 times more potent. In addition, IPI-926 has demonstrated significant anti-tumor activity and excellent pharmaceutical properties, including oral bioavailability, long plasma half-life and duration of action, and dose-dependent inhibition of tumor growth, in a number of preclinical models including pancreatic cancer, small cell lung cancer, and medulloblastoma.
Infinity Pharmaceuticals Inc. Reacquires Worldwide Rights To Its Hsp90 Inhibitor Program
Infinity Pharmaceuticals Inc. announced that it has reacquired from MedImmune, a unit of AstraZeneca, all worldwide development and commercialization rights to its heat shock protein 90 (Hsp90) inhibitor program.
