BioVex Inc, a company developing next generation biologics for the treatment and prevention of cancer and infectious disease, announced today that a Phase 3 pivotal study with OncoVEXGM-CSF for the first line treatment of patients with locally advanced squamous cell carcinoma of the head & neck (SCCHN) has commenced. The study will be conducted across sites in the US and the UK.
Dr Kevin Harrington, Principal Investigator from The Institute of Cancer Research and The Royal Marsden Hospital in London, said:
“Patients with head and neck cancer often present with disease that is too advanced for surgery. These patients are typically treated with radiation and chemotherapy, in some cases followed by surgery. Phase 1/2 data indicates OncoVEX GM-CSF has the potential to decrease the relapse rate in this group of patients and could be safely used in combination with other cancer treatments. We look forward to the results of this large-scale study.“
Dr Robert Coffin, Founder and Chief Technology Officer of BioVex Inc said:
“We believe that OncoVEX GM-CSF has the potential to provide a broadly active new treatment approach that will substantially improve patient outcomes in a variety of hard-to-treat tumor types as both a monotherapy and in combination with other therapies. The start of a second pivotal phase 3 study is part of a broad planned development program for OncoVEX GM-CSF beyond our lead indication of metastatic melanoma. Our OPTiM (OncoVEX Pivotal Trial in Melanoma) study is approaching full accrual.”
Phase III Study Rationale and Design
The Phase III study design agreed with the FDA under the SPA process is based on the design of our previous study in SCCHN. The Phase III study will enroll 528 previously untreated patients with locally advanced disease. The primary objective of the study will be to demonstrate a statistically significant increase in two year event free survival (relapse, progression, or death) for patients treated with chemoradiation together with OncoVEXGM-CSF compared to patients treated with chemoradiation alone.
Phase I/II Study Design and Results
In a Phase I/II study in SCCHN, OncoVEXGM-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 prior to surgical resection. Of the 17 patients enrolled, 16 had Stage IV N2 or N3 disease. OncoVEXGM-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 OncoVEXGM-CSF doses. No patient had a loco-regional recurrence in the neck at a median follow up of 30 months with a disease specific survival rate of 82% at that time.
Source: BioVex Inc