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June 10, 2014
06:32 EDTADXSAdvaxis says End-of-Phase 2 meeting with FDA has been granted to review ADXS-HPV
Advaxis announced that its request for an End-of-Phase 2 meeting with the FDA has been granted. The purpose of the EOP2 meeting with FDA is to review clinical findings to date of Advaxis's immunotherapy product candidate, ADXS-HPV, in order to assess any additional information needed prior to moving ADXS-HPV forward with the next phase of its clinical development. The meeting will establish a dialogue with FDA on ADXS-HPV during which Advaxis can obtain agency recommendations and feedback on the next steps it needs to take in investigating this important immunotherapy product candidate. Advaxis plans to prepare and provide FDA with a comprehensive package detailing its investigational invasive cervical cancer therapy, its phase 1 and 2 clinical findings, its CMC strategy and the Company's plans for a pivotal phase 3 program.
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January 22, 2015
11:04 EDTADXSAdvaxis announces FDA acceptance of IND application to conduct Phase 1 trial
Advaxis (ADXS) announced that the U.S. FDA has cleared its Investigational New Drug application to conduct a Phase 1 clinical study of ADXS-HER2 for the treatment of patients with metastatic HER2 expressing solid tumors. The clinical trial, which will be the first-in-human study of Advaxis's lead Lm-LLO immunotherapy product for HER2 expressing cancers, is expected to begin patient enrollment in the first half of 2015. In May 2014, Advaxis was granted orphan drug designation by the FDA for ADXS-HER2 in osteosarcoma.The Phase 1 clinical study is designed to evaluate the safety and tolerability of ADXS-HER2 as a monotherapy in patients with metastatic HER2 expressing solid tumors such as breast, gastric, esophageal, and osteosarcoma. Results from the study will be used to determine the future clinical development program of ADXS-HER2. The safety and efficacy of ADXS-HER2 is currently being evaluated in an ongoing Phase 1/2 veterinary clinical study in pet dogs with osteosarcoma, conducted by Nicola Mason, BVet.Med, Ph.D., DACVIM, of the University of Pennsylvania School of Veterinary Medicine. To date, dogs treated with ADXS-HER2 immunotherapy, after receiving standard of care had a statistically significant overall survival benefit compared to dogs that only received standard of care. Additionally, the preliminary data suggests immune responses induced by ADXS-HER2 targeted pulmonary micrometastases and prevent the development of metastatic disease in the dog's lungs.Advaxis has granted exclusive worldwide rights to Aratana Therapeutics (PETX) to develop and commercialize ADXS-HER2 for the treatment of osteosarcoma in dogs. In July 2014, Aratana filed a U.S. Department of Agriculture product license application for ADXS-HER2 for the treatment of canine osteosarcoma and other cancers. While the USDA has no specific obligation to respond within a prescribed timeframe, the companies expect a response within 12 to 18 months from the date the application was filed.
January 21, 2015
10:26 EDTADXSHigh option volume stocks
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09:32 EDTADXSAdvaxis mentioned cautiously by Seeking Alpha contributor
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January 20, 2015
10:06 EDTADXSHigh option volume stocks
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