advaxis inc (ADXS) Key Developments
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.
Advaxis, Inc. Announces Results from Clinical Study of ADXS-HER2
Jun 8 15
Advaxis, Inc. announced that results from an ongoing clinical study of ADXS-HER2 in canine osteosarcoma (OSA). Repeat doses of ADXS-HER2 were well tolerated with no systemic or cardiac toxicity. Of the 12 canine patients recruited to date, seven are alive with current survival times ranging from 66 to 479 days. The median survival time of dogs receiving palliative radiation plus ADXS-HER2 has not been reached. The median time to progression of these 12 canine patients is 238 days. The reported median survival time for historical control dogs with OSA that do not undergo amputation but instead receive the same palliative radiation protocol without ADXS-HER2 is 136 days. Data from the first Phase 1 clinical trial in canine OSA were presented last year during the 2014 ACVIM Forum, which showed ADXS-HER2 is able to delay or prevent metastatic disease and significantly prolong overall survival in canines with OSA that had minimal residual disease following standard of care (amputation and follow-up chemotherapy). At the time of the presentation, two-thirds of the treated canine patients were still alive and therefore a median survival time had not been reached. Conversely, historical control dogs that underwent standard of care and did not receive ADXS-HER2 had a median survival time of 316 days. Advaxis licensed ADXS-HER2 to Aratana Therapeutics in March of 2014 for pet health indications and it is now being developed and prepared for commercialization using the name AT-014. Advaxis and Aratana anticipate conditional licensure of AT-014 for the treatment of canine OSA from the U.S. Department of Agriculture (USDA) in 2016. Translating Canine Clinical Research into Human Trials were the canine evidence with ADXS-HER2 may have important translational relevance for human patients with OSA and other HER2+ cancers, such as breast, gastric and esophageal. Advaxis expects to initiate a Phase 1b dose-escalation study of ADXS-HER2 in humans with HER2+ solid tumors in mid-2015. Once dosing is established in the human trial, Advaxis plans to work with Children's Oncology Group (COG) to launch a pivotal trial in human pediatric OSA in early 2016. HER2 is expressed in approximately 40-60% of pediatric and canine OSA and in pulmonary metastatic disease, suggesting that immune targeting of HER2 might delay or eliminate metastatic disease. The hypothesis warrants investigation and will be tested in the pivotal pediatric OSA trial. HER2 expression is associated with more aggressive disease, increased risk of relapse and decreased overall survival.
Advaxis Inc. Announces FDA Clearance of IND Application for Phase 2 Study of ADXS-HPV
Jun 1 15
Advaxis Inc. announced the clearance of the Investigational New Drug or IND application by the United States Food and Drug Administration to conduct a Phase 2 study of ADXS-HPV (ADXS11-001) alone or in combination with Incyte Corp.'s investigational oral indoleamine 2,3-dioxygenase 1 or IDO1 inhibitor, epacadostat (INCB24360), for the treatment of Stage I-IIIb human papillomavirus (HPV)-associated cervical cancer.
Advaxis, Inc. Presents at Jefferies 2015 Global Healthcare Conference, Jun-01-2015 02:00 PM
May 22 15
Advaxis, Inc. Presents at Jefferies 2015 Global Healthcare Conference, Jun-01-2015 02:00 PM. Venue: The Grand Hyatt Hotel, New York, New York, United States. Speakers: Daniel J. O'Connor, Chief Executive Officer, President and Director.