CAMBRIDGE, Mass. and GAITHERSBURG, Md., Nov. 13, 2007 (PRIME NEWSWIRE) -- Infinity Pharmaceuticals, Inc. (Nasdaq:INFI) 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.
About IPI-504
IPI-504 is a small molecule drug candidate being developed jointly by Infinity and MedImmune. In preclinical studies, IPI-504 has been shown to inhibit Hsp90 potently and selectively, thereby affecting cancer cells. IPI-504 has also demonstrated, in preclinical studies, broad potential to treat certain cancers as both a single agent as well as in combination with existing anti-cancer drugs. The water-based formulation of IPI-504 is delivered as an intravenous infusion; the companies' next-generation oral inhibitors of Hsp90 are currently in preclinical development.
About Hormone-Refractory Prostate Cancer
Prostate cancer is the most common noncutaneous malignancy diagnosed in men in the United States. According the American Cancer Society, more than 234,000 American men are diagnosed with prostate cancer annually. Prostate tumors that have stopped responding to hormone therapy or are growing despite the use of active hormone treatment strategies are characterized as hormone-refractory. The only therapy at this time proven to improve survival for men with hormone-refractory prostate cancer is docetaxel-based chemotherapy, with an average improvement in life expectancy of approximately two months. Multiple proteins or pathways have been linked to the progression of hormone refractory disease in prostate cancer patients, including the androgen receptor, the Her-2 receptor, and Akt. Each of these is a client protein of Hsp90, suggesting that inhibition of Hsp90 in HRPC is a promising area for clinical investigation.
About Infinity Pharmaceuticals, Inc.
Infinity is an innovative cancer drug discovery and development company that is seeking to leverage its strength in small molecule drug technologies to discover, develop, and deliver to patients best-in-class medicines for the treatment of cancer and related conditions. For more information on Infinity, please refer to the company's website at http://www.ipi.com.
About MedImmune
MedImmune strives to provide better medicines to patients, new medical options for physicians and rewarding careers to employees. With approximately 3,000 employees worldwide and headquarters in Maryland, MedImmune is dedicated to advancing science and medicine to help people live better lives and is wholly owned by AstraZeneca plc (LSE:AZN) (NYSE:AZN). For more information, visit MedImmune's website at http://www.medimmune.com.
Forward-Looking Statements
This announcement contains, in addition to historical information, certain forward-looking statements that involve risks and uncertainties, in particular statements related to the research and development of IPI-504 and other compounds targeting Hsp90. Such statements reflect the current views of MedImmune and/or Infinity management and are based on certain assumptions. MedImmune is a member of the AstraZeneca Group of companies. Actual results could differ materially from those currently anticipated as a result of a number of factors, including risks and uncertainties discussed in the reports and other documents filed by AstraZeneca plc with the Securities and Exchange Commission and in Infinity's quarterly report on Form 10-Q for the quarter ended September 30, 2007 filed with the Securities and Exchange Commission on November 7, 2007. There can be no assurance that such development efforts will succeed, that the products will receive required regulatory clearance or, even if such regulatory clearance is received, that the subsequent products will ultimately achieve commercial success. Further, any forward-looking statements contained in this announcement speak only as of the date hereof, and AstraZeneca and Infinity expressly disclaim any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as otherwise may be required by applicable law or regulation.
Taxotere(r) (docetaxel) is a registered trademark of the sanofi-aventis group.