$ADXS Submits Special Protocol Assessment Request to FDA


Advaxis Submits Special Protocol Assessment Request to FDA for ADXS-HPV Phase 3 Clinical Trial in Cervical Cancer

Advaxis, Inc. (ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, today announced the company has submitted a Special Protocol Assessment (SPA) request to the U.S. Food and Drug Administration (FDA) to initiate detailed design discussions for a Phase 3 clinical study of ADXS-HPV for the treatment of high-risk, locally advanced cervical cancer (HRLACC). The Phase 3 trial is planned to be conducted in collaboration with the Gynecologic Oncology Group (GOG) Foundation, Inc. and to be led by principal investigator Thomas Herzog, M.D., Professor of Obstetrics & Gynecology and Clinical Director at the University of Cincinnati Cancer Institute, Cincinnati, Ohio.

The SPA request includes specific questions from Advaxis to facilitate a meaningful dialog with the FDA on the proposed study design. Following receipt, the FDA will determine the appropriateness of the SPA request and may take up to 45 calendar days to provide comments to Advaxis. The nature and extent of comments received will determine the need for additional rounds of review and/or a formal meeting. The FDA’s assessment of the SPA request, and all related valuable feedback, will aid to inform the development of ADXS-HPV in locally advanced cervical cancer.

The proposed Phase 3 clinical trial (AIM2CERV) is designed as an adequate and well-controlled double-blind, placebo-controlled multinational study of ADXS-HPV (ADXS11-001) administered in the adjuvant setting following concurrent chemoradiation given with curative intent in patients with HRLACC for whom recurrence has not yet occurred. Advaxis plans to initiate the Phase 3 trial by the end of 2015.

“Submitting our SPA request to the FDA is an important first step in the proposed Phase 3 program for ADXS-HPV in cervical cancer,” said David J. Mauro, M.D., Ph.D., Executive Vice President and Chief Medical Officer of Advaxis. “The decision to evaluate ADXS-HPV in HRLACC is based on the encouraging survival data observed in metastatic cervical cancer (Lm-LLO-E7-15 and GOG-0265)’ and emerging clinical data on the adjuvant use of ADXS-HPV in the treatment of high-risk locally advanced anal cancer; and the adjuvant use of ADXS31-164 in canine osteosarcoma. We believe that ADXS-HPV may have an opportunity to demonstrate a more meaningful clinical impact on the lives of women with cervical cancer in an earlier disease setting and in a subpopulation of patients who are at high risk for recurrence.”

About High-Risk, Locally Advanced Cervical Cancer (HRLACC)

Cervical cancer is the fourth most common cancer and the most common cause of mortality in women worldwide with 528,000 new cases reported annually and an estimated 266,000 deaths in 2012; the majority of which is diagnosed in less-developed countries. Within the United States, approximately 12,900 cases of invasive cervical cancer are diagnosed annually and up to 30 percent are diagnosed with locally advanced disease. Despite a well-established and adopted standard of care for the treatment of locally advanced cervical cancer, consisting of cisplatin and radiotherapy administered concurrently, a large percentage of these patients, particularly those with high risk features and/or poor prognostic factors, will experience cancer recurrence and ultimately die of their disease. These patients represent a subpopulation of locally advanced cervical cancer with the highest unmet medical need and where the need for new therapeutic options is greatest as there are no approved therapies for this specific patient population3.

About GOG Foundation, Inc. (GOG Foundation)

The GOG Foundation, Inc. (GOG Foundation) is an independent international non-profit organization with the purpose of promoting excellence in the quality and integrity of clinical and basic scientific research in the field of gynecologic malignancies. The GOG Foundation is committed to maintaining the highest standards in clinical trials development, execution, analysis and distribution of results. Continuous evaluation of the organization’s processes is utilized in order to constantly improve the quality of patient care. The GOG Foundation conducts clinical trials for patients with a variety of gynecologic malignancies, including cancers that arise from the ovaries, uterus, cervix, vagina, and vulva. The GOG Foundation is a separate entity from the National Clinical Trials Network groups that are funded by the National Cancer Institute.

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 a completed Phase 2 study in recurrent/refractory cervical cancer, ADXS-HPV has shown 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 (FDA) granted orphan drug designations for ADXS-HPV for the treatment of Stage II-IV invasive cervical cancer, HPV-associated head and neck cancer, and for HPV-associated anal cancer.

About Advaxis, Inc.
Located in Princeton, N.J., Advaxis, Inc. is a clinical-stage biotechnology company developing multiple cancer immunotherapies based on its proprietary Lm Technology™. The LmTechnology, using bioengineered live attenuated Listeria monocytogenes bacteria, is the only known cancer immunotherapy agent shown in preclinical studies to both generate cancer fighting T-cells directed against a cancer antigen and neutralize Tregs and myeloid-derived suppressor cells (MDSCs), that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis’s lead Lm Technology immunotherapy, ADXS-HPV, targets human papillomavirus (HPV)-associated cancers and is in clinical trials for three indications: Phase 2 in invasive cervical cancer, Phase 1/2 in head and neck cancer, and Phase 1/2 in anal cancer. The U.S. Food and Drug Administration (FDA) has granted Advaxis orphan drug designation for each of these three indications. For additional information on Advaxis, visitwww.advaxis.com and connect on Twitter, LinkedIn, Facebook, YouTube and Google+.

Forward-Looking Statements
This news release contains forward-looking statements, including, but not limited to: statements regarding Advaxis’s ability to develop the next generation of cancer immunotherapies; and the safety and efficacy of Advaxis’s proprietary immunotherapy, ADXS-HPV. These forward-looking statements are subject to a number of risks, including the risk factors set forth from time to time in Advaxis’s SEC filings, including but not limited to its report on Form 10-K for the fiscal year ended October 31, 2014, which is available at http://www.sec.gov. Advaxis undertakes no obligation to publicly release the result of any revision to these forward-looking statements, which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. You are cautioned not to place undue reliance on any forward-looking statements.

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/advaxis-submits-special-protocol-assessment-request-to-fda-for-adxs-hpv-phase-3-clinical-trial-in-cervical-cancer-300098903.html


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