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its drug works in combination with the chemo agent doxorubicin (Doxil) in animals, and it recently saw some encouraging signs of anti-tumor activity in a Phase Ib clinical trial, Hershberg says. The company has also run preclinical studies, as well as an early-stage clinical trial, that indicate the experimental immune-stimulator could augment a combination of chemotherapy and Eli Lilly’s cetuximab (Erbitux).
Based on those early results, Celgene and VentiRx are forging ahead with the kind of long-term, expensive clinical trials that will be needed to prove the value of the product to physicians, regulators, and insurers. VentiRx plans to start one mid-stage trial of about 210 patients with ovarian cancer who will be randomly assigned to get Doxil or Doxil and VTX-2337, Hershberg says. After that, VentiRx will start another mid-stage trial that will randomly assign about 150 patients with head and neck cancer to get VTX-2337 plus a chemo agent and cetuximab, or the chemo and cetuximab alone. VentiRx will retain control over the development program, although a joint steering committee of Celgene and VentiRx executives will oversee the work, Hershberg says.
Those trials ought to give researchers a clear-cut answer on the value of the new VentiRx drug, which is the kind of evidence the company has been looking to gather for some time. VentiRx has had to watch its spending carefully to get this far. Back in September 2011, the company closed its San Diego branch and consolidated operations in Seattle as it looked to preserve cash. Even now with the additional money coming in from Celgene, Hershberg says the company plans to stay “virtual” with about 10 employees, and keep getting its work done through a network of contractors. “This is really positive step for us to show that the model works for setting up companies virtually, and still being able to do significant clinical development,” Hershberg says.
Like most biotech deals, some personal connections between the companies played a role in getting the ink on paper. Tom Daniel, Celgene’s president of research and early development, used to work at Seattle-based Immunex and at Amgen’s operations in Seattle. He got to know both Hershberg and Steve Gillis, the Immunex co-founder and now chairman of VentiRx, during his time there. “Tom is an extremely thoughtful guy, and there’s definitely a connection there,” Hershberg says.