Treating cervical cancer with bacteria, clinical trial of immunotherapy has been released by the FDA July 16, 2018 Source: WuXi PharmaTech Recently, Advaxis, a biotechnology company focused on discovering, developing and marketing immunotherapeutic products, announced that the US FDA has cancelled its combination of axalimogene filolisbac (AXAL) and durvalumab in the treatment of advanced relapsed or refractory cervical cancer and HPV-related head and neck cancer. Clinical control of a new drug (IND) application for Phase 1/2 studies. AXAL is an immunotherapy targeting Listeria monocytogenes (Lm), which produces anti-cancer T cells against cancer antigens by altering live strains of Lm bacteria, while neutralizing and protecting the tumor microenvironment. Protected by HPV-related cancers by the natural protection of immune attacks. In a phase 2 trial evaluating AXAL for persistent or recurrent metastatic (squamous or non-squamous cell) cervical cancer (PRmCC), the candidate showed a 12-month overall survival rate of 40 in 50 patients. %. Based on prognostic factors, this is a 52% increase in the expected 12-month overall survival rate in the trial population. AXAL has been granted fast-track access for adjuvant therapy for high-risk locally advanced cervical cancer (HRLACC) and a special protocol assessment for AIM2CERV in phase 3 trials in HRALCC patients. The immunotherapy is also eligible for orphan drugs in three clinical indications. However, Advaxis submitted a safety report to the FDA on March 9 this year about a patient's death on February 27, which developed acute respiratory failure nine months after dosing. Therefore, the FDA issued clinical controls for this study. However, Advaxis has agreed with the FDA on new guidelines for early detection and treatment of such rare events and will be implemented in the study. All other Advaxis and durvalumab clinical items were enrolled and administered without this clinical control. Advaxis R&D pipeline (Source: Advaxis official website) “We are pleased to address this issue with the FDA and will implement these guidelines in the Advaxis portfolio as needed to ensure patient safety. Based on our multiple trials in HPV-related cancers, approximately 400 patients were treated and over With 1200 doses of experience, we are still confident in the safety of AXAL,†said Dr. Kenneth A. Berlin, President and CEO of Advaxis. Reference materials: [1] Advaxis Announces FDA Lifts Clinical Hold On Phase 1/2 Combination Study Of Axalimogene Filolisbac With Durvalumab [2] Advaxis official website Disposable Products,Disposable Scissors,Disposable Camera Sleeve,Laparoscopic Disposable Trocar ZHEJIANG SHENDASIAO MEDICAL INSTRUMENT CO.,LTD. , https://www.sdsmedtools.com