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May 12, 2014
07:35 EDTPETXAratana Therapeutics initiates pivotal study for AT-001
Aratana Therapeutics announced the initiation of the pivotal field effectiveness study for AT-001, the company's innovative drug for treating pain in dogs with osteoarthritis. The randomized, blinded, multicenter pivotal study will enroll approximately 300 client-owned dogs with osteoarthritis, and will be conducted under a study protocol for which Aratana received concurrence from the FDA's Center for Veterinary Medicine. The primary endpoint will be a reduction in osteoarthritis pain compared to placebo, as indicated by the Canine Brief Pain Inventory scale, a well validated and widely used scoring system.
News For PETX From The Last 14 Days
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January 23, 2015
15:34 EDTPETXAratana Therapeutics management to meet with Leerink
Group luncheon to be held on Boston at 12 pm on January 26 hosted by Leerink.
January 22, 2015
11:04 EDTPETXAdvaxis 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.

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