WOBURN, Mass., March 30 /PRNewswire/ -- BioVex Inc, a company developing new generation biologics for the treatment and prevention of cancer and infectious disease, announced today it has raised $40 million in the first close of a series F private financing.
The placement was led by Forbion Capital Partners, who were joined by other existing investors including Credit Agricole Private Equity, Harris & Harris Group, Innoven Partners, New Science Ventures, Triathlon Medical Venture Partners and Scottish Equity Partners.
Philip Astley-Sparke, President & CEO for BioVex Inc said:
"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. 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."
The Phase III study design agreed with the FDA under a Special Protocol Assessment (SPA) follows directly from the study design successfully employed in Phase II. The Phase III study will also enroll previously treated patients with unresectable Stage IIIc and Stage IV disease using OncoVEX GM-CSF as monotherapy. Stage IIIb patients will also be eligible. The primary efficacy endpoint will also be response rate-based; the primary objective being to demonstrate a statistically significant increase in the rate of objective responses maintained for six months or more, in comparison to control therapy (subcutaneously administered GM-CSF). The study is intended to enroll 360 evaluable patients randomized such that 240 patients receive OncoVEX GM-CSF and 120 patients receive control. BioVex plans to begin enrolling patients for the Phase III study in the second quarter of 2009.
About OncoVEX GM-CSF Phase II Clinical Trial
BioVex recently concluded a 50-patient Phase II trial for OncoVEX GM-CSF as a standalone therapy in patients with unresectable Stage IIIc and Stage IV metastatic melanoma. The trial was designed to measure overall objective response, which is defined as a complete response (CR), where disease is completely eliminated, or partial response (PR), where there is a >50% reduction in disease burden. 87% of patients who entered the study were progressing after having failed prior therapy. 13 objective systemic responses (26% objective response rate) were achieved including eight CRs. Eleven responses have so far continued for more than 6 months (range 5-28+ months). Responses were observed in patients with all stages of disease, including the complete resolution of un-injected visceral deposits.
BioVex is a privately held biotechnology company based in Woburn, MA. The Company is developing a new class of potent biologics for the treatment of cancer and prevention of infectious disease.
The Company's lead cancer technology platform, OncoVEX GM-CSF is a first-in-class oncolytic, or cancer destroying virus technology. OncoVEX GM-CSF works by: replicating and spreading within solid tumors, causing the death of cancer cells; while stimulating the immune system to destroy un-injected metastatic deposits. Both modes of action have been clearly validated in the clinic, where multiple patients with metastatic disease progressing at enrollment have been declared disease free. BioVex believes OncoVEX GM-CSF has the potential to become a leading standard of care in the treatment of many solid tumors based on the strength of clinical data generated to date, coupled with a benign side effect profile.
The Company's second program is a vaccine for genital herpes, ImmunoVEX HSV2, which provides complete protection in animal models of the disease. The vaccine has been authorized to commence clinical testing in the UK.
For further information, please go to www.biovex.com.
|SOURCE BioVex Inc|
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