advaxis inc (ADXS) Key Developments
Advaxis, Inc. Appoints Shelonitda S. Rose as Vice President, Clinical Development
Jul 8 15
Advaxis, Inc. announced that it has appointed Shelonitda S. Rose, M.D., as Vice President, Clinical Development. Dr. Rose brings to Advaxis more than 15 years of experience in medical oncology and hematology clinical research. In her role as Vice President, Clinical Development, Dr. Rose will report to Advaxis's Executive Vice President, Chief Medical Officer, David J. Mauro, MD, Ph.D., and will oversee clinical development programs for the Company's Lm Technology™ platform. Most recently, Dr. Rose served as Director, Oncology Clinical Research for Merck & Co., Inc.
Advaxis, Inc.(NasdaqCM:ADXS) added to Russell 2000 Index
Jun 30 15
Advaxis, Inc. will be added to Russell 2000 Index
Advaxis, Inc.(NasdaqCM:ADXS) added to Russell 3000 Index
Jun 30 15
Advaxis, Inc. will be added to the Russell 3000 Index.
Advaxis, Inc. - Special Call
Jun 19 15
To review recent accomplishments and key near-term milestones of the company
Advaxis, Inc. Submits Special Protocol Assessment Request to the U.S. Food and Drug Administration to Initiate Detailed Design Discussions for ADXS-HPV Phase 3 Clinical Trial in Cervical Cancer
Jun 15 15
Advaxis, Inc. 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.