AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO) today announced that the United States Adopted Names (USAN) Council, in consultation with the World Health Organization (WHO) International Nonproprietary Names Expert Committee, has approved the use of the nonproprietary generic name “ficlatuzumab” (pronounced fye” kla tue’ zue mab) for AV-299, a potent, functional anti-HGF/c-MET antibody internally discovered at AVEO. Ficlatuzumab is currently being evaluated in a Phase 2 clinical trial in combination with gefitinib (Iressa™) versus gefitinib monotherapy in patients with non-small cell lung cancer (NSCLC).
“We believe the HGF/c-MET pathway is an exciting and newly validated target in oncology drug development and represents a novel approach which may address many cancers for which there is a high unmet medical need,” said William Slichenmyer, M.D., Sc.M., chief medical officer at AVEO. “Ficlatuzumab is the lead antibody emerging from our promising antibody pipeline. Data from preclinical and Phase 1 studies of ficlatuzumab demonstrate a well-tolerated profile and good combinability with EGFR inhibitors, such as erlotinib and gefitinib, and we look forward to continuing to advance ficlatuzumab in the clinic.”
The USAN Council serves health professionals in the United States by selecting simple, informative, and unique nonproprietary names for drugs by establishing logical nomenclature classifications based on pharmacological and/or chemical relationships to ensure that drug information is communicated accurately and unambiguously. The USAN Council aims for global standardization and unification of drug nomenclature by working closely with the International Nonproprietary Name Programme of WHO and various national nomenclature groups.
About Ficlatuzumab and HGF/c-MET Pathway
The HGF/c-MET pathway is believed to play an important role in regulating tumor growth, invasion and metastasis, making it an exciting novel target in oncology. In addition, preclinical and clinical observations suggest that increased HGF and/or c-MET receptor amplification may confer resistance to EGFR inhibitors. Ficlatuzumab, also known as AV-299, is a potent, functional anti-HGF/c-MET antibody that was discovered by AVEO through its Human Response Platform™ (HRP). In AVEO’s proprietary tumor models with elevated HGF/c-MET signaling, ficlatuzumab exhibited strong additive anti-tumor effect when given in combination with other approved anti-cancer agents such as erlotinib (Tarceva®), cetuximab (Erbitux®) and temozolomide (Temodar®). In additional preclinical studies, ficlatuzumab was more effective at inhibiting tumor growth (at the dose tested) than other anti-HGF antibodies currently in clinical development.
Following successful completion of earlier clinical trials, AVEO initiated a Phase 2 clinical trial evaluating ficlatuzumab in combination with gefitinib (Iressa™) versus gefitinib monotherapy in patients with NSCLC in June 2010. Top-line data from the ongoing Phase 2 trial are expected in 2012.
AVEO Pharmaceuticals (NASDAQ: AVEO) is a cancer therapeutics company committed to discovering, developing and commercializing targeted therapies to impact patients’ lives. The company’s lead product candidate, tivozanib, is currently being investigated in a global, randomized Phase 3 clinical trial called TIVO-1 comparing tivozanib to sorafenib in patients with advanced renal cell carcinoma, as well as additional clinical studies in other solid tumor types. AVEO’s second most advanced product candidate, ficlatuzumab (AV-299), is a potent, functional anti-HGF/c-MET pathway antibody that is currently in Phase 2 clinical development. AVEO’s proprietary Human Response Platform™ is designed to offer the company a unique advantage in cancer drug development and has provided a discovery engine for multiple therapeutic targets. This approach has resulted in a promising pipeline of monoclonal antibodies against novel targets including HGF, ErbB3, RON, Notch and FGFR. For more information, please visit the company’s website at www.aveopharma.com.
Any statements in this press release about our future expectations, plans and prospects, including statements about the role of HGF/c-Met pathway in regulating tumor growth, invasion and metastasis, ficlatuzumab’s (AV-299) favorable combinability and tolerability profile, the timing of top-line data from the ficlatuzumab Phase 2 clinical study, the potential benefit from combination therapy of an EGFR TKI and an inhibitor of the HGF/c-Met pathways, our cancer biology platform increasing the probability of clinical success and providing a discovery engine for high-value targets, and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: our ability to successfully research, develop and obtain and maintain regulatory approvals for ficlatuzumab, tivozanib and our other product candidates; the possibility that favorable data from our Phase 1 clinical trials of ficlatuzumab may not be predictive of the results in our Phase 2 clinical trial; delays in data availability, or negative results from our Phase 2 clinical trial of ficlatuzumab; our inability to obtain and maintain adequate protection for intellectual property rights relating to our product candidates and technologies; unplanned operating expenses; our inability to raise substantial additional funds to achieve our goals, including with respect to the further development of tivozanib and ficlatuzumab; general economic and industry conditions; and other factors discussed in the "Risk Factors" section of our most recent Form 10-Q filed with the Securities and Exchange Commission, and in other filings that we periodically make with the SEC. In addition, the forward-looking statements included in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
Tarceva® and Iressa® are registered trademarks of OSI Pharmaceuticals, Inc. and the AstraZeneca group of companies, respectively.
AVEO Pharmaceuticals, Inc.
Monique Allaire, 617-299-5810
Caton Lovett, 910-232-7166