What is OncoVAX®?

OncoVAX®:

Uses the patient’s own cancer cells to prevent recurrence of the disease, a pioneering approach that could redefine treatment protocols for Stage II cancer patients;
Has had more than 30 years and over $300 million (USD) in Research & Development since 1972;
Has been authorized for commercial use in Switzerland - revenues to begin in Q3 2008. Formal distribution agreement entered with Pharmacenter in Hungary for distribution in Hungary, Czech Republic, Slovakia, Romania, Bulgaria, Slovenia and Poland - roll-out schedule to take place over a two year period. Discussions under way with other potential distribution partners for parts of Europe, the Middle East and parts of Asia.
Has completed a major Phase IIIa clinical trial, and has been granted Fast Track status by the FDA for the treatment of Stage II colon cancer. The pivotal Phase IIIb protocol has also received a Special Protocol Assessment ("SPA") by the FDA.

OncoVAX® is an active specific immunotherapy (ASI) that uses the patient’s own cancer cells to block the return of colon cancer following surgery. This patient-specific vaccine comprises sterile, metabolically active, irradiated, non-tumorigenic autologous tumor cells, with or without fresh frozen bacillus Calmette-Guerin ("BCG") bacterial as an adjuvant.

OncoVAX® is an active specific immunotherapy (ASI) that uses the patient’s own cancer cells to block the return of colon cancer following surgery.

This is how OncoVAX® works: following surgery to remove the Stage II color cancer, the tumor cells are processed in Vaccinogen’s facility in the Netherlands. The vaccine created in this process is injected into the patient’s skin in four doses over the first six months after the surgery. The injections produce a delayed-type hypersensitive response which indicates that the body’s own T-cells will respond to tumor antigens.

In short, the vaccine unleashes the body’s own immune system to fight a cancer that it otherwise would not have recognized.

OncoVAX® has successfully completed its first Phase IIIa trial in Stage II colon cancer with outstanding, statistically significant, results:

25% improvement in 5-year median overall survival;
39% improvement in 5-year median recurrence-free survival; and
64% decrease in the number of patients whose disease progressed 18 months following treatment.

OncoVAX®’s clinical data is far more comprehensive than other immunotherapy products in development:

In five clinical studies, 383 patients have been treated with the vaccine; and
It has completed pharmacoeconomic analysis which indicated that its pricing is competitive with approved prescriptions in colon cancer treatment.