On April 6, 2015 Advaxis reported that it is entering into a clinical trial collaboration agreement with the Radiation Therapy Oncology Group (RTOG) Foundation to evaluate the safety and efficacy of Advaxis’s lead cancer immunotherapy, ADXS-HPV (ADXS11-001), in a pivotal Phase 2/3 anal cancer trial, which will be run by NRG Oncology (Press release, Advaxis, APR 6, 2015, View Source [SID:1234502925]). ADXS-HPV is an investigational Lm-LLO immunotherapy bioengineered to generate an immune response to the HPV-associated tumor specific oncogene. Schedule your 30 min Free 1stOncology Demo! Under the proposed collaboration, RTOG Foundation, through its partnership with NRG Oncology, will conduct an adequate and well-controlled Phase 2/3 clinical trial of concurrent chemotherapy of mitomycin C/5FU and radiation therapy (CCRT) compared to CCRT combined with ADXS-HPV in the adjuvant treatment of high-risk locally advanced anal cancer.
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Walter J. Curran, Jr., MD, RTOG Foundation Chairman of the Board and NRG Oncology Group Chair, commented, "The ability of ADXS-HPV to generate an immune response to the HPV-associated tumor specific oncogene offers the potential to benefit multiple cancers that are known to be caused by the HPV infection, including cervical cancer and anal cancer. We look forward to initiating this Phase 2/3 study in anal cancer and mirroring the encouraging results that the Gynecologic Oncology Group, now a part of NRG Oncology, has had in its clinical study of ADXS-HPV in cervical cancer."
David J. Mauro, MD, PhD, Executive Vice President and Chief Medical Officer of Advaxis, stated, "We are excited to enter this collaboration agreement with NRG Oncology and look forward to building on the initial results observed in the ongoing Phase 1/2 study of ADXS-HPV in anal cancer being conducted by Professor Howard Safran MD of Brown University Oncology Group. Although a relatively rare tumor, virtually all cases of squamous cell cancer of the anus are caused by HPV infection, and ADXS-HPV offers the potential to treat this often fatal malignancy."
About RTOG Foundation, Inc.
The Radiation Therapy Oncology Group (RTOG) has been an international leader in conducting Phase 2 and 3 multi-institutional clinical trials with a focus on radiation oncology issues. During its forty-plus year history, the group has repeatedly defined new standards of cancer care to improve the survival and quality of life of cancer patients and developed new processes for the study and application of innovative radiotherapy technologies. RTOG Foundation, Inc. is a Philadelphia based 501(c)(3) organization that continues its National Cancer Institute (NCI) funded research activities through NRG Oncology as one of its three founding members. RTOG also joins with corporate partners to conduct multicenter clinical trials systematically testing novel radiotherapy approaches combined with new classes of anti-cancer therapies and targeted agents. The group has completed a number of practice- and paradigm-changing trials in its primary disease sites: central nervous system, head & neck, lung, gastrointestinal (esophagus, stomach, pancreas, anal canal, and rectum), genitourinary (bladder and prostate), breast, and cervix.
About NRG Oncology
NRG Oncology conducts practice-changing, multi-institutional clinical and translational research to improve the lives of patients with cancer. Founded in 2012, NRG Oncology is a Pennsylvania-based nonprofit corporation that integrates the research strengths of the National Adjuvant Breast and Bowel Project (NSABP), the Radiation Therapy Oncology Group (RTOG) and the Gynecologic Oncology Group (GOG). The research organization seeks to carry out clinical trials with emphases on gender-specific malignancies including gynecologic, breast, and prostate cancers and on localized or locally advanced cancers of all types. NRG Oncology’s extensive research organization is comprised of multidisciplinary investigators including medical oncologists, radiation oncologists, surgeons, physicists, pathologists, and statisticians and encompasses more than 1300 research sites located world-wide with predominance in the United States and Canada. NRG Oncology is supported primarily through grants from the National Cancer Institute (NCI) and is one of five research groups in the NCI’s National Clinical Trials Network.
About ADXS-HPV
ADXS-HPV is Advaxis’s lead Lm-LLO immunotherapy product candidate for the treatment of HPV-associated cancers. It is currently under investigation in three HPV-associated cancers: invasive cervical cancer, head and neck cancer, and anal cancer. In cervical cancer, a completed Phase 2 study, ADXS-HPV demonstrated prolonged survival, objective tumor responses, and a manageable safety profile alone or in combination with chemotherapy, supporting further development of this Lm-LLO immunotherapy. The U.S. Food and Drug Administration granted an orphan drug designation for ADXS-HPV for HPV-associated Stage II-IV cervical cancer, head and neck cancer, and for anal cancer.