OncoVAX® is an autologous cancer vaccine manufactured with a patented process to leverage a patient’s own tumor cells to launch a potent and customized immune response against residual cancer cells that may reside in the body after surgery. Killing these cells is key to preventing the recurrence of the cancer.
The Company believes that OncoVAX®, at an optimum dose and regimen, is the first patient-specific vaccine to significantly reduce the post-surgical risk of colon cancer recurrence. In a Phase III study, OncoVAX® reduced the risk of recurrence in stage II colon cancer from one in three patients to one in ten.
Five clinical studies of OncoVAX® treatment in colon cancer, including the phase IIIa trial which established optimum dose and regimen, have been completed to date. The Company has begun a pivotal phase IIIb trial (ACTIVE) under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) and expects to start enrolling patients in early 2015.
The FDA has also granted fast track status for its lead indication: OncoVAX®. A Fast Track product is defined as a new drug or biologic intended for the treatment of a serious or life-threatening condition that demonstrates the potential to address unmet medical needs. Fast track status helps expedite the development and review of new therapeutics and is a significant advantage for bringing new treatments to the clinic in a timely manner.
While our primary focus is currently stage II colon cancer, we also plan to advance clinical development of OncoVAX® in stage III patients utilizing various combination therapies. Data from earlier studies also indicate OncoVAX® may have clinical efficacy in other solid tumors including renal cell carcinoma and melanoma.