Ayala Pharmaceuticals Inc (ADXS)

[James salmon]

Re GOG phase 2 study

I noted from Zacks report today he noted the following;

The first stage has been completed and has met the predetermined safety and efficacy criteria required to proceed into the second stage of patient enrollment. Dr. Copeland mentioned that a minimum 12-month survival rate of 20% was used as the efficacy threshold for this trial since a persistent or recurrent cervical cancer patient has a 1 year survival rate between 10% and 15%. As of the presenting day, the 12-month survival rate for the first stage was 24% (7/29), which exceeded the 20% predetermined rate. When follow-up data continue to come out, we believe the final 12-month survival data for the first stage of the trial will be higher than the current 24%.

One more important thing about the GOG 265 trial is that all patients treated in the first stage of the trial had advanced disease and some had experienced five to seven rounds of chemo- or radiation therapies. These data are encouraging since they confirmed the 12-month survival rate of 29% achieved in the Indian Phase II study that included patients with less severe disease.

Now we know that 6 patients from original 29 are still alive and 5 persons did not complete all 3 doses. If you exclude these 5 and and some of the remaining 6 survive past 12 months, Advaxis absolutely blew away the 20% survival at 12 months that GOG wanted to achieve. We also know that the patient population used in the trial were very ill some having received multiple doses of chemo or radiation.

It's no wonder that GOG wanted to be involved in phase 3.