WOBURN, Mass.--(BUSINESS WIRE)--BioVex Inc, a company developing new generation biologics for the treatment of cancer and prevention of infectious disease, announced today that the U.S. Food and Drug Administration (FDA) has agreed that BioVex’s ongoing OPTiM clinical study in unresectable Stage IIIb-IV melanoma be amended to include untreated (i.e., first line) patients as well as previously treated patients as defined in the original protocol. This amendment has been agreed under the Special Protocol Assessment (SPA) procedure, thus maintaining the SPA status of the protocol. The amendment will expand the eligible pool of patients and allow patients to volunteer for the study as an alternative to, rather than only following, standard treatment approaches.
About OncoVEX GM-CSF
OncoVEX GM-CSF is a first in class oncolytic vaccine. OncoVEX replicates selectively in tumors; destroying cancer cells whist leaving surrounding healthy cells unharmed. OncoVEXGM-CSF is also intended to induce a powerful immune response to kill cancer cells throughout the body. Both local and distant modes of action have been validated in the clinic, where multiple patients with metastatic disease progressing at enrollment have become free of disease. Based on the tolerability and efficacy profile noted to date, BioVex believes OncoVEX GM-CSF has the potential to become a leading standard of care in the treatment of many solid tumors. Previous clinical trials have enrolled patients with breast cancer, melanoma, head and neck cancer and pancreatic cancer, with indications of clinical activity being observed in each. The Company recently commenced a Phase 3 study in metastatic melanoma (the OPTiM study) following achieving an unprecedented proportion of durable complete remissions in a Phase 2 study using OncoVEXGM-CSF as a stand alone therapy in patients with advanced disease (see Journal of Clinical Oncology, Vol 27, 2009: pp. 5763-5771). In September 2009 the Company received approval for a second Phase 3 study, in head and neck cancer, also under the SPA procedure.
About BioVex
BioVex is a privately held biotechnology company based in Woburn, Mass. where it also has an operational launch grade manufacturing facility. The Company is developing a new class of potent?biologics for the treatment of cancer and prevention of?infectious disease. In addition to OncoVEX, the Company has a second development program, ImmunoVEX HSV2, a vaccine for genital herpes that provides complete protection in animal models of the disease. The vaccine has been authorized to commence clinical testing in the United Kingdom. BioVex recently closed a $70m funding round representing the second largest venture capital raise in the biotech sector in 2009. For further information, please go to www.biovex.com.
Contact:
BioVex Inc. Philip Astley-Sparke, 781-376-4913 President & CEO pastleysparke@biovex.com or Suda Communications, LLC Mariesa Kemble, 608-850-4745 kemblem@mac.com
