Phase III Study Design
The Phase III study design agreed with the FDA follows directly from the design of the previous study. The Phase III study will also enroll previously untreated patients with locally advanced disease. The primary objective of the study will be to demonstrate a statistically significant increase in 2-year event free survival (i.e. relapse, progression, or death) for patients treated with chemoradiation together with OncoVEX (GM-CSF) as compared to patients treated with chemoradiation alone. The study will involve approximately 400 patients with approximately 200 in each arm.
Phase I/II Study Design and Results
In a Phase I/II study, OncoVEX (GM-CSF) was administered by direct injection, at three dose levels, into tumor containing lymph nodes in combination with standard first line chemo radiotherapy every three weeks for four cycles. All patients then went for surgery. Of the 17 patients enrolled, 16 had Stage IV N2 or N3 disease. OncoVEX (GM-CSF) was shown to be well tolerated with no significant side effects in addition to those associated with chemoradiation. With respect to efficacy, 93% of patients had a complete pathological response at surgery, with five patients achieving a complete response after only 2 or 3 virus doses. No patient to date has had a loco-regional recurrence in the neck at a median follow up of 30 months, and the disease specific survival rate is currently 82%.
Dr Robert Coffin, Founder and Chief Technology Officer, for BioVex, said:
"Loco-regional control is extremely important in head and neck cancer where loco regional progr
|SOURCE BioVex Inc|
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