Biotech Values

[DewDiligence]

ADXS presents phase-1 data on higher-dose AXAL in second-line cervical cancer:

http://finance.yahoo.com/news/advaxis-provides-phase-1-data-120000184.html

Nine patients who had documented disease progression after they had received curative treatments of chemotherapy and/or radiation with or without bevacizumab were enrolled in this phase 1, open-label, dose-determining study.

Axalimogene filolisbac [a/k/a AXAL] was well-tolerated across two dose levels. The study also established a recommended phase 2 dose of 1×10^10 CFU and demonstrated antitumor activity at that dose.

Axalimogene filolisbac was safely administered at 5 and 10 times the dose levels previously studied, without any significant toxicity. One patient experienced an ongoing and durable partial response.

…There was only one instance of dose-limiting toxicity, with that patient experiencing a grade 3 treatment related adverse event (TRAE) of hypotension at a dose of 5×10^9 CFU. Across all doses, eight of nine patients experienced a grade 1-2 TRAE, including chills, nausea and hypotension.

Second-line cerivical cancer is the additional indication where ADXS hopes to start a phase-3 AXAL trial during 2017. ADXS’ in-progress phase-3 AXAL trial, called AIM2SERV, is testing AXAL in adjuvant (non-metastatic) cervical cancer.