1) From the phase Two 49 patient cohort, and the DURATION of the phase 3, my analysis produces appx. 40 month median Overall Survival(mOS) and a Durable Response Rate (NYSEARCA:DRR)= appx. 40%.
2) These results will be equivalent to the PD-1 drugs efficacy in Melanoma, but without 14% grade 3 and grade 4 side effects.
3) The major excitement at ASCO from Wall st analysts concerning the PD-1 drugs, was related to their usage in ALL solid tumor cancers, not just in Melanoma. But, the evidence thus far shows much less efficacy in other solid tumor cancers than in Melanoma. The response rate drops down to the teens and low twenty % in the other solid tumor cancers.
4) PD-1 drugs will NOT work if the cancer in question is NOT utilizing PD-1 mechanism to escape attack.
It is because the Melanoma has greater immunogenicity than other solid tumor cancers, that it has developed greater usage of PD-1 mechanism to escape attack.
5) Because Allovectin-7 only highlights to the immune system that a cancer cell is foreign, and therefore requires attack, it should produce even better results in cancers that have fewer other defense mechanisms, than in Melanoma.
6) When a solid tumor is inoperable and metastatic, there are very few options left. Chemo and Avastin are the main drugs used for all the metastatic cancer patients. But, Chemo only works in a few people, and the DRR is usually in the single digits. Avastin has similar efficacy as chemo, while with fewer adverse effects, they are still nasty.
Nobody is cured of cancer thru the use of Avastin, still it is one of the best selling cancer drugs of all time.
7) While Allovectin-7 still must produce actual clinical results in other solid tumor cancers, in order to document its efficacy, FDA approval will allow OFF LABEL usage in the meantime.
8) Appx. 66% of all cancer drugs are used OFF LABEL
9) OFF LABEL cancer drug usage is driven by desperation, and by the time and money required for individual FDA pivotal studies in separate indications.
10) Off Label cancer drug usage is also driven by total costs. Most other countries and US based insurance companies will NOT pay for off label usage UNLESS the total costs are reduced. Complications, such as grade 3 to 5 side effects greatly increase costs. Which is why a "DIRTY" drug like Yervoy has very limited off label usage.
11) Because Allovectin-7 can CURE metastatic cancer, with NO grade 3 to 5 side effects, it will have the highest off label usage of any cancer drug ever.
12) While it is highly likely that the largest indications for A-7 , Lung, Breast, Prostate, head & neck, etc., will be included in FDA pivotal studies, there are many other solid tumor cancers that will not. While these studies are being run, A-7 will be used off label in any solid tumor where conventional drugs are NOT wanted by the patients. Both Doctors and patients will choose off label use of a potential cure, that has no major adverse effects, over conventional treatments that have low probabilities of success, and have horrible adverse effects. Some Docs will suggest forgoing chemo and Avastin, in favor of A-7 because of the favorable side effect profile, which will greatly reduce complication costs.
13) While injecting A-7 directly into the lungs, liver, pancreas, and other vital organs will pose some risks, many currently used regimens produce the same or greater risks, with very minimal results. So, while cancers originating in a vital organ require more close monitoring for A-7 usage, carefully placed injections directly into the cancerous lesion, could prove to be highly effective.
14) Solid tumor Cancer only exists because they are escaping T-cell attack. A-7 will prove to be the most effective way of causing T-cells to attack these cancers. Therefore, A-7 will become the most successful broadly used cancer drug of all time.
Disclosure: I am long VICL.