NeuVax's purpose is to prevent the recurrence of breast cancer, and in December the company announced final results for its Phase II trial that showed only 5.6% of patients' cancer recurred when treated with NeuVax, compared to 25.9% of those who were not vaccinated. Now, we await interim Phase III results in 2013, and there are three factors that give Galena a high probability of success, which could also lead the stock to becoming one of the best investments ever:
NeuVax was used to treat both node-positive and node-negative patients in its Phase II trial. However, in the Phase III PRESENT trial it will only be tested on node-positive patients. NeuVax was much more efficient on this patient population. For this reason, the Phase III trial is built around the strengths of the vaccine and the results could actually be better than in its Phase II trial.
All of the patients in the Phase III trial will be optimally dosed. In the Phase II trial only one-third of patients were optimally dosed. This was because the folks at Galena were still trying to determine the best way of using the vaccine. After sorting through the results, Galena and the FDA found an optimal dosing level and determined that all patients in the Phase III trial should be dosed with the most efficient level of NeuVax; or the one that showed the best response.
All patients will receive booster shots of NeuVax. These boosters have shown a meaningful impact at preventing recurrence as a long-term treatment, and will be incorporated into the Phase III trial. It should be noted that only half of the Phase II patients received booster shots.
These are very solid scientific evidences that we can expect better results than Phase 1 & 2 trials.
Since the FDA was involved witht he design of NeuVax's Phase 3, there is also reasons to think that if and when the interim results from Phase 3 demonstrate equal or better results, the FDA may be prepared to give NeuVax a "fast track" or "provisional approval" status so that NeuVax can be used to save lives as soon as possible.
Let us all be patient and see how the universe will unfold!