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May 27, 2014
08:36 EDTADXSAdvaxis' HER2 immunotherapy candidate receives Orphan Drug Designation
Advaxis announced that it has been granted Orphan Drug Designation, or ODD, from the FDA Office of Orphan Products Development for ADXS-cHER2 for the treatment of osteosarcoma. ADXS-cHER2 is an immunotherapy under investigation for targeting the HER2 receptor, which is overexpressed in certain solid-tumor cancers, including bone cancer and breast cancer. Based on strong pre-clinical and canine osteosarcoma clinical data, Advaxis is planning to initiate a clinical development program with ADXS-cHER2 in pediatric patients with osteosarcoma. Pediatric osteosarcoma affects about 400 children and teens in the U.S. every year, representing a small but significant unmet medical need that has seen little therapeutic advancement in decades. Both veterinary and human osteosarcoma specialists consider canine osteosarcoma to be the most analogous disease to human osteosarcoma.
News For ADXS From The Last 14 Days
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January 27, 2015
10:01 EDTADXSAdvaxis strength due to more than stock promotion, TheStreet says
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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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