ADXS-"Axalimogene filolisbac, which received orpha

ADXS-"Axalimogene filolisbac, which received orphan drug designation and Fast Track designation for adjuvant therapy in HRLACC and orphan drug designation for stage II-IV cervical cancer from the FDA and was classified as an advanced therapy medicinal product (ATMP) for the treatment of cervical cancer by the European Medicines Agency's (EMA) Committee for Advanced Therapies (CAT), has shown encouraging activity and a manageable safety profile in phase 2 studies. Last year, the company presented positive data from the completed Phase 2 GOG-0265 study showing a promising rate of survival in persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC). Top-line data released in 2016 showed a 12-month overall survival rate of 38 percent observed in 50 patients in the trial. This was a 52 percent improvement over the 12-month overall survival rate that was expected in the trial’s patient population based on prognostic factors. The most commonly reported side effects were hypotension and symptoms related to cytokine release, including nausea, chills and fever. The full data set from the GOG-0265 study will be presented at the Society of Gynecologic Oncology’s 48th Annual Meeting on Women’s Cancer in March."