Aveo Pharmaceuticals, Inc. 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 II 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, MD, Sc.M., chief medical officer at AVEO. “Ficlatuzumab is the lead antibody emerging from our promising antibody pipeline. Data from preclinical and phase I 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 non-proprietary 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 non-proprietary name programme of WHO and various national nomenclature groups.

The HGF/c-MET pathway is believed to play an important role in regulating tumour 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 tumour models with elevated HGF/c-MET signalling, ficlatuzumab exhibited strong additive anti-tumour 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 tumour 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 II 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 II trial are expected in 2012.

AVEO Pharmaceuticals 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 III 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 tumour types.