Replies to post #192964 on Biotech Values

[DewDiligence]

Re: ADXS’ ADXS-HPV in anal cancer

So, the CEO noted patients out past two years of treatment but cited a 3-year recurrence rate? How do you know the disease doesn't typically recur in the third year in this patient population?

The probability of recurrence follows an exponential curve, as one would intuitively expect—i.e. there is no significant spike in the recurrence rate during the third year following treatment.

p.s. The NRG Oncology cooperative likes ADXS’s preliminary anal-cancer data enough to want to conduct a phase-3 trial if NCI provides funding.

[Bulbaman]

>>How do you know the disease doesn't typically recur in the third year in this patient population?

I don’t know. What I do know is, based on the cited ADXS anal cancer drug efficacy, the respected Radiation Therapy Oncology Group (RTOG) has agreed to run a pivotal Phase 2/3 anal cancer trial in collaboration with Advaxis. Also, I trust that ADXS management isn’t just hyping their stock by highlighting their anal cancer results. Of course, it’s possible I’m being naive. ;-)

[DewDiligence]

ADXS—ASCO abstract re Brown University IST in anal cancer:

http://abstracts.asco.org/199/AbstView_199_187362.html

The objective of this study was to determine the safety of ADXS11-001 with mitomycin, 5-FU and IMRT (chemoradiation therapy, CRT) and obtain preliminary data on progression free survival (PFS) in locally advanced anal cancer.

…Results: The study enrolled the first pt in April 2013. Ten patients were treated (median age 62.5, range 37-71) including 5 with pelvic adenopathy. Two patients had grade 3 toxicities related to the vaccine including chills/rigors (n = 2), back pain (n = 1), hyponatremia (n = 1). All toxicities were within 24 hours of the vaccine and resolved successfully with standard care. There was no exacerbation of CRT toxicities or myelosuppression. One patient had a grade 5 cardiopulmonary event shortly after beginning 5-FU treatment which was judged to be unlikely related to ADXS11-001and possibly related to CRT.

Eight patients treated on the study had a complete response at six-month sigmoidoscopy. One additional patient who did not undergo six-month sigmoidoscopy had complete response on sigmoidoscopy performed at approximately one year. Eight of 9 patients (89%) are disease-free at a median follow-up of 34 months.

Conclusions: ADXS11-001 can be safely administered with CRT for anal cancer. Promising PFS was observed in patients with locally advanced disease [emphasis added].

The ct.gov listing for this trial is at: https://clinicaltrials.gov/show/NCT01671488 .