Data from trial with OncoVEX GM-CSF in metastatic melanoma is expected in 2010.
BioVex raised $40 million in the first close of a series F private financing to push its melanoma drug into Phase III testing for which the company expects final data in 2010.
OncoVEX GM-CSF is an oncolytic virus technology. It replicates and spreads within solid tumors, causing the death of cancer cells, while stimulating the immune system to destroy un-injected metastatic deposits, the company explains.
“Following the unprecedented number of durable complete remissions generated with our lead cancer product, OncoVEX GM-CSF, in a Phase II study in metastatic melanoma, the funds will be used to commence a pivotal Phase III study,” notes Philip Astley-Sparke, president & CEO.
BioVex’ 50-patient Phase II trial evaluated OncoVEX GM-CSF as a stand-alone therapy in patients with unresectable Stage IIIc and Stage IV metastatic melanoma. The company found that 26% had an objective response rate, which included eight complete responses.
The Phase III study will follow the design employed in Phase II. It will also enroll previously treated patients with unresectable Stage IIIc and Stage IV disease. The primary objective is to demonstrate a statistically significant increase in the rate of objective responses maintained for six months or more in comparison to control therapy GM-CSF. The study is intended to enroll 360 evaluable patients beginning in the second quarter. A total of 240 patients will receive OncoVEX GM-CSF and 120 patients receive control.
“The board is currently examining a number of options to raise a further $20 million to fund preparations for a BLA filing following the generation of Phase III data in 2010,” Astley-Sparke continues.
Forbion Capital Partners led the round and was joined by existing investors including Credit Agricole Private Equity, Harris & Harris Group, Innoven Partners, New Science Ventures, Triathlon Medical Venture Partners, and Scottish Equity Partners.
