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News Breaks
May 5, 2014
07:39 EDTADXSAdvaxis to initiate clinical development of ADXS-cHER2
Advaxis announced it intends to initiate a clinical development program with its product candidate, ADXS-cHER2, for the treatment of pediatric osteosarcoma. ADXS-cHER2 is an immunotherapy that targets the HER2 oncogene, which is overexpressed in certain solid-tumor cancers, including pediatric bone cancer and breast cancer. In a veterinarian clinical study, pet dogs with naturally occurring osteosarcoma treated with ADXS-cHER2 after the standard of care showed a statistically significant prolonged overall survival benefit compared with dogs that received standard of care without ADXS-cHER2. Both veterinary and human osteosarcoma specialists consider canine osteosarcoma to be the best model for human osteosarcoma. Building on these data, Advaxis now intends to initiate a clinical development program 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 improvement in decades. Pediatric osteosarcoma is considered a rare disease and may qualify for regulatory incentives including, but not limited to, orphan drug designation, patent term extension, market exclusivity, and development grants. Given the limited availability of new treatment options for pediatric osteosarcoma, and that it is an unmet medical need affecting a very small number of patients in the U.S. annually, the company believes that, subject to regulatory approval, the potential to be on the market may be accelerated.
News For ADXS From The Last 14 Days
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October 30, 2014
07:55 EDTADXSAdvaxis ADXS-cHER2 demonstrates T-cell immune response
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October 23, 2014
10:01 EDTADXSOn The Fly: Analyst Initiation Summary
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07:06 EDTADXSAdvaxis initiated with a Buy at H.C. Wainwright
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October 20, 2014
07:34 EDTADXSAdvaxis names Mauro Chief Medical Officer
Advaxis (ADXS) announced that it has appointed David Mauro, as executive vice president, Chief Medical Officer Mauro most recently served as executive director, section head oncology clinical development at Merck (MRK). In connection with his appointment, Mauro received a one-time inducement award of 165K restricted shares, of which 55K are fully vested and as of the grant date. The remaining shares vest annually over a two-year period.

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