On June 08, 2016 Advaxis, Inc. (NASDAQ:ADXS), a clinical stage biotechnology company developing cancer immunotherapies, reported dose administration for the first patient in the first stage of its Phase 2 clinical trial of their FAWCETT study, testing the Company’s lead immunotherapy candidate, axalimogene filolisbac (AXAL), in patients with persistent or recurrent metastatic anal cancer (Press release, Advaxis, JUN 8, 2016, View Source [SID:1234513150]). Schedule your 30 min Free 1stOncology Demo! The multi-center, open-label, two-stage study is designed to evaluate the efficacy and safety of AXAL as a monotherapy in patients with HPV-associated metastatic anal cancer who have received at least one prior treatment regimen for the advanced disease. Stage 1 of the trial will enroll 31 patients with anal cancer whose disease recurred after receiving treatment. Patients will receive AXAL 1×109 colony forming unit (CFU) doses every three weeks for up to two years.
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In collaboration with Brown University Oncology Research Group, AXAL has been evaluated in high-risk, locally advanced anal cancer with concurrent standard chemotherapy and radiation treatment. Preliminary data show treatment with AXAL indicated a clinical complete response and no recurrence in all 10 patients who completed the treatment regimen.
"The FAWCETT study is an important step in the development program for AXAL," said Daniel J. O’Connor, President and Chief Executive Officer at Advaxis. "People living with anal cancer desperately need new treatment options, which is why Advaxis is pursuing two areas of evaluation, including monotherapy with AXAL and a second study with an immune checkpoint inhibitor in combination with AXAL."
The FAWCETT (Fighting Anal-Cancer with CTL Enhancing Tumor Therapy) study was named in honor of Farrah Fawcett, who passed away due to HPV-associated anal cancer. In 2015, the Farrah Fawcett Foundation honored Advaxis with its inaugural "Medical Visionary Angel Award" based on the Company’s clinical research and efforts to treat this disease, initiating a partnership among the organizations.
About Anal Cancer
Anal cancer is a fairly rare form of cancer in the United States, but the number of new anal cancer cases has been rising for years. The risk of being diagnosed with anal cancer in one’s lifetime is about 1 in 500. According to the American Cancer Society, approximately 7,270 new cases of anal cancer were diagnosed and about 1,010 people died of the disease in 2014.
About Axalimogene Filolisbac
Axalimogene filolisbac (AXAL) 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, AXAL 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. AXAL has Orphan Drug Designations in the U.S. for the treatment of invasive cervical cancer, head and neck cancer and anal cancer.
About the Farrah Fawcett Foundation
The mission of the Farrah Fawcett Foundation is to provide funding for cutting edge cancer research, to support prevention and awareness, and to help those struggling with cancer today. Farrah Fawcett was diagnosed with anal cancer in 2006 and established the Foundation before her death in 2009. For more information, visit www.thefarrahfawcettfoundation.org and follow them on Facebook.