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News Breaks
June 6, 2014
07:33 EDTADXSAdvaxis announces presentation of updated ADXS-cHER2 data
Advaxis announced that its principal investigator presented updated data from the ongoing ADXS-cHER2 study in canine osteosarcoma at the 2014 American College of Veterinary Internal Medicine Forum. The preliminary findings of the Phase 1 clinical trial in dogs with osteosarcoma suggest that ADXS-cHER2 is safe and well tolerated at doses up to 3 x 109 CFU with no evidence of cardiac, hematological, or other systemic toxicities. The study determined that ADXS-cHER2 is able to delay or prevent metastatic disease and significantly prolong overall survival in dogs with osteosarcoma that had minimal residual disease following standard of care. At the time of the presentation, 80% of the dogs treated were still alive and median survival had not yet been reached. Median survival in control dogs was 316 days. Immunological analyses are also being conducted in this study to further evaluate the immune response to ADXS-cHER2. Recently, ADXS-cHER2 was granted orphan drug status for the treatment of human osteosarcoma by the U.S. Food and Drug Administration Office of Orphan Products Development.
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February 3, 2016
08:11 EDTADXSAdvaxis' Axalimogene Filolisbac to be developed in Latin America with Stendhal
Advaxis announced that it has entered into a co-development and commercialization agreement with Especificos Stendhal SA de CV, for Advaxis' lead Lm Technology immunotherapy, axalimogene filolisbac, in HPV-associated cancers. Stendhal is a privately held Latin American specialty pharmaceutical company that partners with leading drug companies to deliver effective solutions for life-threatening diseases in Latin American markets. Under the terms of the Agreement, Stendhal will pay $10M toward the expenses of AIM2CERV, a planned global Phase 3 clinical trial in women with high-risk, locally advanced cervical cancer. This payment covers a significant portion of the total planned study costs. Stendhal will also work with Advaxis to complete the clinical trial of axalimogene filolisbac in Mexico, Brazil, Colombia, and other investigational sites in Latin American countries. Additionally, Stendhal will manage the regulatory approval process, promotion, commercialization and market access for axalimogene filolisbac in these markets. Advaxis and Stendhal will share profits on a pre-determined basis.

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