FDA Approves For Pivotal Phase III Study With OncoVEX

The FDA has approved the design of a single, pivotal, phase III clinical trial evaluating BioVex’s lead product, OncoVEX (GM-CSF), for the first-line treatment of patients with squamous cell cancer of the head and neck.

Reportedly, the study is the second the company has agreed with the FDA under the Special Protocol Assessment (SPA) procedure and highlights the broad potential utility of BioVex’s first-in-class cancer destroying virus technology. The first SPA was in melanoma under which BioVex is currently conducting a pivotal phase III trial.

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 (ie, 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.

Philip Astley-Sparke, president and CEO of BioVex, said: “The announcement of our second SPA governing a phase III study demonstrates the breadth of the commercial opportunity with OncoVEX (GM-CSF). In addition to treating metastatic disease as is the intention in our ongoing phase 3 study in melanoma, following multiple systemic responses in phase II, OncoVEX (GM-CSF) also has considerable potential utility in treating discrete solid tumor masses across multiple indications including those that are poorly served by radiation.

“ It is our belief that, as a result, this technology has the potential to provide a broadly active new modality to substantially improve patient outcomes in a variety of hard-to-treat tumor types. “