On March 07, 2016 Advaxis, Inc. (NASDAQ:ADXS), a clinical stage biotechnology company developing cancer immunotherapies, reported dose administration for the first patient in the expansion phase of an ongoing Phase 2 clinical trial of its lead Lm immunotherapy candidate, axalimogene filolisbac (AXAL), in patients with persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC) (Press release, Advaxis, MAR 7, 2016, View Source [SID:1234509384]). Schedule your 30 min Free 1stOncology Demo! The interventional, open-label, non-randomized dose-escalation study is designed to evaluate the safety, efficacy and immunological effect of AXAL administered at doses up to 1 x 1010 colony forming units (CFU) in repeat cycles of treatment in approximately 25 women with cervical cancer whose disease recurred after receiving one prior cytotoxic treatment regimen. The study is being led by principal investigator Sharad Ghamande, M.D., Director of Gynecology Oncology at GRU Cancer Center, Augusta University in Augusta, Ga.
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Launch of the expansion phase follows a poster presentation of preliminary data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2015 Annual Meeting, where data from 9 patients showed that AXAL could be safely administered with prophylactic antibiotics up to 1 x1010 CFU, a tenfold increase from prior dosing regimens at 1 x 109. Adverse events at this high dose were consistent with previous experience with predominately grade 1 or grade 2, transient events that self-resolved or were resolved with anti-inflammatory agents (NSAIDS) and antiemetics. The high dose expansion phase will include 15 patients.
"The launch of the expansion phase of this clinical study is an important next step in AXAL’s development program. This study will further explore what our research has shown to date – that a higher dose drives an increase in protein expression in the cytosol and results in greater generation of T cells to the HPV target," said Daniel J. O’Connor, President and Chief Executive Officer of Advaxis. "AXAL holds the potential to fill an unmet treatment gap for women with recurrent cervical cancer."
About Cervical Cancer
Cervical cancer is the fourth most common cancer in women worldwide. In the United States, nearly 13,000 new cases are diagnosed and approximately 4,100 deaths are reported because of cervical cancer. According to the WHO/ICO Information Centre on HPV and Cervical Cancer, about 3.9 percent of women in the U.S. are estimated to harbor high-risk cervical HPV infection at a given time, and 71.7 percent of invasive cervical cancers are attributed to high-risk HPV strains.
About Axalimogene Filolisbac
Axalimogene filolisbac (ADXS-HPV) is Advaxis’ lead Lm Technology immunotherapy candidate for the treatment of HPV-associated cancers and is in clinical trials for three potential indications: invasive cervical cancer, head and neck cancer, and anal cancer. In a completed randomized Phase 2 study in recurrent/refractory cervical cancer, axalimogene filolisbac showed apparent prolonged survival, objective tumor responses, and a manageable safety profile alone or in combination with chemotherapy, supporting further development of the company’s Lm Technology. Axalimogene filolisbac has Orphan Drug Designation in the U.S. for the treatment of invasive cervical cancer, head and neck, and anal cancer.