Combination with Taxotere Provides Additional Paths for Development of Novel Hsp90 Inhibitor in Lung, Prostate, and Breast Cancers
CAMBRIDGE, Mass. and GAITHERSBURG, Md. - January 04, 2008 - Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) and MedImmune announced that they have initiated a Phase 1b clinical trial of IPI-504 in combination with Taxotere® (docetaxel) in patients with advanced solid tumors. IPI-504, the companies' lead heat shock protein 90 (Hsp90) inhibitor, is currently in clinical development for a number of solid tumor cancers. Enrollment for this new study has commenced at Memorial Sloan-Kettering Cancer Center in New York, N.Y., with additional sites expected to be added as the study progresses.
"This trial marks the first exploration of IPI-504 in combination with chemotherapy," said David Grayzel, M.D., vice president, clinical development and medical affairs, Infinity. "Clinical and preclinical evidence to date suggests that Hsp90 inhibition has therapeutic potential in many indications where Taxotere is effective, including lung, prostate, and breast cancers."
The goal of this open-label, dose-escalation study is to establish the safety, maximum tolerated dose (MTD), and optimal schedule of administration for IPI-504 in combination with Taxotere. Initially, patients will receive 75 mg/m2 of Taxotere followed by 300 mg/m2 of IPI-504 on day one of each 21-day cycle. Once an MTD is reached, the trial will expand to enroll up to 20 additional patients. Additional schedules, including once-weekly dosing of IPI-504 and Taxotere, may also be explored as the trial progresses.
In preclinical models of prostate cancer, Taxotere demonstrates increased anti-tumor activity when administered in combination with IPI-504. In addition, preclinical data suggest that IPI-504 may have anti-cancer properties in prostate, lung, and breast cancers - all tumors in which Taxotere has demonstrated clinical efficacy. These data provide a rationale for investigating IPI-504 in combination with Taxotere in multiple tumor types.
IPI-504 is a small molecule drug candidate being developed jointly by Infinity and MedImmune. IPI-504 has shown promising biological activity and been well-tolerated in Phase 1 clinical trials in patients with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) and patients with advanced non-small cell lung cancer (NSCLC). The Phase 2 single-agent dose and schedule of IPI-504 has been established as 400 mg/m2 on a three-week cycle, consisting of twice-weekly treatment for two weeks followed by one week off treatment. At the Phase 2 dose level, the companies are currently conducting the expansion portion of a Phase 1 trial of patients with refractory GIST and other soft tissue sarcomas and the Phase 2 portion of a Phase 1/2 trial in advanced NSCLC. IPI-504 is also being evaluated in a Phase 2 study in patients with hormone-refractory prostate cancer. In preclinical studies, IPI-504 has been shown to inhibit Hsp90 potently and selectively, thereby killing cancer cells.
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.infi.com.
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.L, NYSE: AZN). For more information, visit MedImmune's website at http://www.medimmune.com.
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. 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® is a registered trademark of sanofi-aventis U.S. LLC INFI-G
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Jamie Lacey, 301-398-4035
Peter Vozzo, 301-398-4358