Decades of research and clinical trials have led us to this point.

This Phase III clinical trial was performed under the auspices of the National Cancer Institute / NIH in response to previous smaller studies carried out at Johns Hopkins, Mass General and Lehigh Valley hospital under Dr. Herbert Hoover.  The Eastern Cooperative Oncology Group (ECOG) desired to perform this study and was headed by Dr. Herbert Hoover and Dr. Jules Harris.  Though there were no significant improvement in Disease-Free Survival (DFS), this trial did show that patients could mount a cellular immune response to their own tumor, using a vaccine consisting of autologous, metabolically active, non-tumorigenic, tumor cells.  This was the first time that there was any significant evidence that a patient could be made to respond immunologically to their own tumor.  Based on this trial we determined that a booster should be added to the regimen of three vaccinations to improve the response.

This Phase III trial included three vaccinations, followed by a booster 6 months after surgery, where BCG was added to the vaccine of the first and second vaccination. This study showed a significant improvement in Disease-Free Survival (DFS) followed out to 10 years.  Since the average age of the patients in this study was approximately 60 years, the FDA recognized that overall survival in this age group was not a representative of an improvement in overall survival, but rather DFS was the appropriate endpoint.  

 In this trial, based on the volume of tumor required to formulate four vaccines (>3g), we treated both advanced disease Stage 2 (T3 and T4) and Stage 3 patients.  

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The Stage 2 Colon Cancer (T3-T4) group of patients showed a 20% in improvement in survival over a 5-year follow up with durability of greater than 10 years.

In his paper on Active specific immunotherapy, Jan B. Vermorken followed up with patients receiving OncoVAX® and showed the standard 5 year survival rates.  The hospitals continued to follow patients and provided 10-year data.  The non-treated controls were evaluated by J. Milburn Jessup, MD FACS of George Mason University who stated that “The survival of the control is as we expected for advanced grade stage 2 colon cancer, T3 and T4 patients, when I was responsible for the colorectal cancer 8th Edition of the AJCC Cancer Staging Manual.  A 20% improvement in long term survival is amazing.” 

Halfway through the 8701 trial, Folfox was declared the treatment of choice for Stage 3 patients, and therefore we terminated the treatment of Stage 3.  While there was an improvement in DFS in Stage 3 patients, it was not statistically significant due the insufficient number of Stage 3 patients completing the regimen.

Though treatment of this group was discontinued during the trial, we now have FDA-approved protocols available to treat Stage 3 patients in a combinatorial with OncoVAX®, Folfox, surgery trial.

Subsequent to the 8701 Trial, the FDA instituted new sterility requirements on all vaccines approved by FDA.  Since the OncoVAX® vaccine was produced from live tumor cells present in the colon, the FDA would not approve this non-sterile vaccine.  Producing a sterile version of OncoVAX® was a technical challenge that took several years to perfect.  Using a novel method utilizing three antibiotics, we developed a sterile vaccine in consultation with the FDA, and a bioequivalency study was completed in October 2003.  The 8701 study was accepted by FDA as the basis and support for the Phase IIIB Study, and the complete set of correspondence between Vaccinogen and the FDA is available for review.  In addition, the FDA required additional automated testing for potency and identity, and that we be able to manufacture the vaccine in sufficient quantities to address at least 30% of the assessable patients (100’s of thousands of patients per year).  

OncoVAX® was developed through  decades of research and clinicial trials with some of the top researchers and facilities worldwide.  Contact us to find out more.