Clinical Trials: Proof of Efficacy
In drug development, the proof is in the clinical trial…and OncoVAX® has demonstrated outstanding success in early trials. As a result, it has been granted SPA and Fast Track status by the FDA.
* This published, randomized Phase IIIa clinical trial was stratified by tumor stage so that a legitimate analysis by tumor stage could be calculated. These results are for Stage II colon cancer. Some benefit was seen in Stage III colon cancer however the results were not statistically significant. This study was accepted by the FDA as supportive data for the next Phase IIIb clinical trial to be conducted under an FDA granted SPA with Fast Track designation. The Disease-free Survival clinical endpoint will be used for the interim analysis, which is an accepted basis for FDA approval.