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News Breaks
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.
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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June 19, 2015
10:42 EDTADXSAdvaxis to host business news update conference call
Conference call to be held on June 25 at 8:30 am. Webcast Link

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