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the earlier study wasn’t a fluke, in an ongoing study that’s expected to enroll as many as 430 patients, according to a posting on clinicaltrials.gov. The goal will be to show the BioVex drug offers an advantage in tumor shrinkage that lasts six month or more, compared to an immune-boosting compound.
Running a trial that big costs money, and the new $30 million is needed to enable BioVex to finish the trial, with a goal of filing for FDA approval in mid-2011, Astley-Sparke says. If that happens on time, the company could win clearance to start marketing OncoVex as soon as the end of 2011, he says.
BioVex, which has about 50 employees in Woburn and 25 more in the U.K., is built on research by Robert Coffin at University College London. Its treatment is based on the herpes simplex virus, the one that causes cold sores. BioVex deleted a gene that the virus needs to infect healthy tissues, while leaving intact the machinery that lets the virus replicate inside tumors. Once the engineered virus gets inside a tumor, it’s supposed to cause the tumor to burst.
At least two other companies, Germany-based MediGene and Calgary, Canada-based Oncolytics Biotech, are also pursuing oncolytic virus treatments for cancer. BioVex says its treatment is further along in clinical trials and is poised to be the first to reach the marketplace.
The oncolytic virus model doesn’t need to be personalized to individual patients, so it can avoid some of the manufacturing hassles that are common with cancer immunotherapies like Seattle-based Dendreon’s sipuleucel-T (Provenge), Astley-Sparke says. The BioVex treatment also can be applied to multiple tumor types—the company says it has encouraging data for its treatment against four malignancies, and has agreed with the FDA on the design of another pivotal trial of OncoVex for patients with head and neck cancer.