CAMBRIDGE, Mass. and GAITHERSBURG, Md., Dec. 19, 2007 (PRIME NEWSWIRE) -- Infinity Pharmaceuticals, Inc. (Nasdaq:INFI) 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.
About IPI-504
IPI-504 is a small molecule drug candidate being developed jointly by Infinity and MedImmune. IPI-504 has been well-tolerated and has shown promising biological activity in Phase 1 clinical trials in patients with metastatic and/or unresectable gastrointestinal stromal tumors and patients with advanced non-small cell lung cancer. 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. 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.
About Non-Small Cell Lung Cancer
The American Cancer Society (ACS) reports that lung cancer is the leading cause of cancer death for both men and women. The ACS estimates that approximately 214,000 new cases of lung cancer will be diagnosed in the United States in 2007. According to the ACS, non-small cell lung cancer is the most common form of lung cancer, accounting for about 85 percent of all lung cancers. In some cases, specific mutations have been identified in a cellular signaling enzyme called epidermal growth factor receptor (EGFR). These mutations allow the survival signal of the mutated cancer cell to be switched "on" all the time. NSCLC patients with mutations in EGFR have been found to benefit from existing therapies that block EGFR signaling. Over time, however, resistance mutations develop such that patients become resistant to these agents. Mutated EGFR is a highly-sensitive client protein of Hsp90, suggesting that inhibition of Hsp90 in NSCLC is an attractive area for clinical study.
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, Inc.
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.
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. 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.
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