Ayala Pharmaceuticals Inc (ADXS)

[Traderbx]

This is the top star of ADXS

The safety and efficacy of axalimogene filolisbac was evaluated in a Phase 2 study under an investigator-sponsored IND by Brown University in patients with high-risk locally advanced anal cancer. As of December 2016, 11 patients were enrolled and all patients who have completed radiation treatment and received treatment experienced a six-month complete response (n=9), with no evidence of recurrence. Eight of 9 patients (89%) are disease-free at a median follow-up of 34 months. These data were accepted for publication in the on-line journal at American Society of Clinical Oncology (“ASCO”) 2017.

In consideration of these data, no further enrollment in this study is planned and the investigator at Brown University is evaluating the opportunity to transition this study into a NCI-funded cooperative group trial to evaluate the safety and efficacy of axalimogene filolisbac in a pivotal Phase 2/3 anal cancer trial, to be conducted by NRG Oncology. In advance of the foregoing, we have entered into a clinical trial collaboration agreement with the Radiation Therapy Oncology Group (“RTOG”) Foundation for the conduct of such study. Depending on the Company’s ability to agree upon the study design and budget, the Company plans to initiate a randomized, registrational quality study in high-risk locally advanced anal cancer. Similar to AIM2CERV, our goal for this monotherapy trial is to develop a treatment to prevent or reduce the risk of anal cancer recurrence after primary care treatment in patients who are at a high risk for recurrence. Subject to the positive outcome of this study, we plan to file for drug approval for high-risk locally advanced anal cancer.