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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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June 30, 2015
09:26 EDTADXSOn The Fly: Pre-market Movers
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June 25, 2015
07:34 EDTADXSAdvaxis provides milestones outlook for 2015 and 2016
The company anticipates the following milestones through the remainder of 2015 and into 2016 for ADXS-HPV: Commence enrollment in the Phase 3, registration quality trial, AIM2CERV; Complete enrollment in Stage 2 of the ongoing GOG-0265 Phase 2 trial of ADXS-HPV in persistent or recurrent cervical cancer being conducted by the Gynecologic Oncology Group, anticipating up to 38 patients enrolled by June 30, 2016 with Final Stage 1 safety and efficacy data to be presented at an upcoming major medical meeting in 2015. Final study data to be available in the first half of 2017; Enroll the first patient this summer in a collaborative Phase 1/2 study of ADXS-HPV in combination with AstraZeneca/MedImmune's MEDI4736 in cervical cancer and HPV-associated head and neck cancer in second half of 2015 with data available in the first half of 2016; Complete enrollment in Part A of our Phase 1 study evaluating higher doses of ADXS-HPV immunotherapy and repeat cycles of treatment with data available from Part A in 2016. Complete enrollment of the Mount Sinai investigator-sponsored Phase 1/2 study of ADXS-HPV in patients with HPV-associated head and neck cancer. Data to be available in the first half of 2016; Commence enrollment in a Phase 2 study in patients with HPV-associated metastatic anal cancer by year's end with data available in the second half of 2016; Commence enrollment in the second half of 2015 on the Phase 1/2 combination study with Incyte Corporation's IDO-1 inhibitor. Expects to complete enrollment in Part A in the first half of 2016 in the Phase 1/2 study of ADXS-PSA as a monotherapy or in combination with Merck's anti-PD-1 therapy, Keytruda, in metastatic, castration-resistant prostate cancer. Data to be available in second half of 2016. Expects to enroll the first patient in a Phase 1 first-in-human trial of ADXS-HER2 in metastatic HER2 expressing solid tumors in the second half of 2015 with data to be available in the second half of 2016; Initiate a clinical study of ADXS-HER2 in pediatric osteosarcoma in partnership with the Children's Oncology Group in 2016; Secure conditional license for ADXS-HER2 for the treatment of canine osteosarcoma from the U.S. Department of Agriculture in 2016.
June 24, 2015
11:19 EDTADXSAdvaxis management to meet with Jefferies
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