     Results from Phase 1 Study of AVEO’s Novel Triple VEGF Receptor Inhibitor AV-951FOR IMMEDIATE RELEASE Contacts:
Company Initiates Phase 2 Clinical Trial of AV-951 in Patients with RCC Cambridge, MA, November 6, 2007 – AVEO Pharmaceuticals, Inc., a biotechnology company leveraging breakthrough discoveries in cancer biology to discover, develop and commercialize targeted oncology therapies, today announced positive results from an expanded Phase 1 clinical trial of its lead product candidate, the novel triple VEGF receptor inhibitor AV-951. Strong activity was observed in the Phase 1 clinical trial consisting of 40 patients with advanced solid tumors; AV-951 was also found to be well tolerated. Notably, of the nine patients with refractory renal cell carcinoma, all achieved either a partial response or stable disease as defined by the trial protocol, with one patient exhibiting a response lasting more than 30 months. Based on this compelling Phase 1 data, AVEO has initiated a Phase 2 clinical trial of AV-951 in patients with metastatic renal cell carcinoma. The placebo-controlled, randomized discontinuation trial will assess the safety and efficacy of once-daily, oral AV-951 in approximately 200 patients at 30 sites in Europe and India under a U.S. IND. The primary endpoints of this trial are objective response rate and percentage of patients who are progression free at 12 weeks following randomization. “AV-951 is a highly potent VEGFR inhibitor and one of the only agents to demonstrate potent activity against all three critical VEGF receptors. As such, we believe AV-951 has the potential to be best-in-class against a validated target demonstrated to be important in multiple cancer types,” said Tuan Ha-Ngoc, president and chief executive officer of AVEO. “Given the strong signals of activity and excellent safety profile observed in Phase 1, AV-951 has the potential to be effective both as a single-agent and in combination regimens benefiting multiple tumor types.” Ha-Ngoc added, “Furthermore, we plan to apply our unique Human Response Platform to identify additional patient populations likely to respond to AV-951 as well as optimal agents for use in combination with AV-951. We expect to initiate further clinical trials of AV-951 in combination with other anti-cancer therapies in solid tumors in the next several months.” In this Phase 2 trial, all patients will receive 16 weeks of AV-951, after which time they will be evaluated for response, stable disease or progressive disease. Those patients who experience a partial or complete response will remain on therapy; those patients who experience stable disease will be randomized to receive 12 weeks of AV-951 or placebo in a double-blind fashion. For more information, please visit the NIH Clinical Trials web site at http://www.clinicaltrials.gov. “Even with the marketed VEGF targeted agents in oncology and more in development, there remains a significant need for a better drug targeting the VEGF pathway which is not only potent, specific and well-tolerated but can also be easily combined with other anti-cancer drugs,” stated Dr. Robert Figlin, Chair, Division of Medical Oncology & Therapeutics Research, and Arthur and Rosalie Kaplan Professor of Medical Oncology at the City of Hope Comprehensive Cancer Center in Duarte, CA. “The promising results observed in the Phase 1 trial with AV-951 are highly encouraging, and the unique mechanism of action which has shown activity against all three VEGF receptors at picomolar concentrations suggests the potential for a superior therapeutic index beyond the current VEGF inhibitors.” About AV-951 About AVEO |
|
 |
|
