Regeneron and Aventis begin study of intravenous VEGF Trap in cancer
US-based Regeneron Pharmaceuticals is initiating a Phase I clinical trial in cancer to assess the safety and tolerability of intravenous VEGF Trap. The study is being conducted in collaboration with Aventis, Regeneron's partner in the development of the VEGF Trap in oncology and eye disorders.
US-based Regeneron Pharmaceuticals is initiating a Phase I clinical trial in cancer to assess the safety and tolerability of intravenous VEGF Trap. The study is being conducted in collaboration with Aventis, Regeneron's partner in the development of the VEGF Trap in oncology and eye disorders.
Vascular Endothelial Growth Factor (VEGF) has been associated with the abnormal growth of new blood vessels surrounding tumours to support their expansion. The VEGF Trap has been shown in preclinical studies to block the action of VEGF, thereby blocking the abnormal growth of blood vessels, and a VEGF antibody has demonstrated efficacy in advanced clinical programmes.
The initial Phase I clinical trial of the VEGF Trap is nearing completion. In this study, the VEGF Trap was administered subcutaneously to patients with solid tumours or non-Hodgkin's lymphoma. The primary objectives of the study were to determine the safety, tolerability and preliminary antitumour activity of the VEGF Trap. The maximum dose in this study was limited to 1.6mg/kg per week, and there have been no indications to date that a maximum tolerated dose would be reached among the doses tested in the trial. Results from this study will be presented at the American Society of Clinical Oncology (ASCO) annual meeting in June 2004.
Rapid attainment of higher plasma VEGF Trap levels than could be achieved with subcutaneous administration will be a goal of the new study, which will evaluate increasing dose levels of the VEGF Trap delivered intravenously to patients with advanced solid tumours or non-Hodgkin's lymphoma. As in the initial Phase I trial, the primary endpoints of the new study will be to evaluate the safety and tolerability of higher doses of the VEGF Trap and to determine the pharmacokinetics of the molecule delivered intravenously.
'The FDA's recent approval of the first angiogenesis inhibitor to treat cancer not only validates the approach but also encourages the development of other antiangiogenesis agents, such as the VEGF Trap, that may be more effective,' said Dr Leonard S. Schleifer, president and ceo of Regeneron. 'Our preclinical research shows that the VEGF Trap is, perhaps, the most potent blocker of VEGF described and may play a role in treating an array of diseases, including cancer, in which the growth of new blood vessels is an important contributor to the disease process.'