OncoVAX Authorized by Dutch
Posted by Jim H on May 8, 2008
In a press release yesterday, it was announce that Frederick-based Vaccinogen‘s potential blockbuster colon cancer “vaccine” therapy has been approved for manufacture at their Emmen, Netherlands facility.
From the FoxBusiness web site:
FREDERICK, Md., May 7, 2008 /PRNewswire via COMTEX News Network/ —-Vaccinogen Inc. said Dutch health authorities licensed it to manufacture its break-through OncoVAX anti-colon cancer vaccine, immediately clearing the path to more than $100 million of potential European sales.
The Dutch approval of the company’s facility based in Emmen, The Netherlands also paves the way to its pivotal US FDA Phase IIIb clinical trial — the final step before the vaccine can be sold in the United States.
“The facility can produce up to 3,500 vaccines annually, equivalent to $130 million in revenues,” said Michael G. Hanna, Jr., Ph.D., Vaccinogen CEO. “That number only scratches the surface of potential demand for a Stage II colon cancer vaccine. One of every three patients who have their cancer removed see it return — and the results are usually fatal.”
“Our experience with OncoVAX has resulted in increasing the patients’ chance of survival by more than 50%,” he concluded. “This represents an opportunity for a new lease on life for tens of thousands of patients around the world.”
The Dutch license permits the company to commercialize the vaccine, first in Switzerland and then in seven other countries in Eastern Europe. The OncoVAX vaccine represents a potential medical breakthrough because it uses a patient’s own cancer cells to prevent the cancer from returning after a successful operation to remove it.
The product is actually not a standard “vaccine” like you’d get for rabies or HPV or influenza. These vaccines are produced and tested in large batches in fermenters and everyone gets essentially the same dose. OncoVAX is actually an autologous vaccine, whereby a small section of the excised tumor is sent by the surgeon to the production facility where the tumor section is processed and made antigenic. It is then injected back into the patient, where their own body produces antibodies to the tumor and kills it.
While Vaccinogen is not the only company working on this new era of “personalized medicine”, they are among the first to pave the way through clinical trials. This explains, in part, the extreme effort (in terms of $$ and time) it has taken to get this novel process through the rigors of FDA approval in the States.