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News Breaks
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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April 17, 2015
17:03 EDTADXSAdvaxis files to sell $200M of common stock
April 13, 2015
08:43 EDTADXSAdvaxis price target raised to $25 from $14 at H.C. Wainwright
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April 8, 2015
16:22 EDTADXSOn The Fly: Closing Wrap
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07:33 EDTADXSAdvaxis, Merck begin enrollment in Phase 1/2 of ADJX-PSA with Keytruda
Advaxis (ADXS) and Merck (MRK) announced that enrollment has initiated in the Phase 1/2 clinical trial evaluating the combination of ADXS-PSA, an investigational Lm-LLO immunotherapy, and Keytruda, the first anti-PD-1 therapy approved in the United States, in patients with previously treated, metastatic castration-resistant prostate cancer, or mCRPC. The clinical trial, KEYNOTE-046, is the first-in-human study of Advaxis's lead Lm-LLO immunotherapy candidate for prostate cancer. It is the second study initiated to evaluate the use of KEYTRUDA in the treatment of advanced prostate cancer. ADXS-PSA and KEYTRUDA are members of a class of cancer treatments known as immuno-oncology therapies. Data from preclinical studies suggest that Advaxis Lm-LLO immunotherapies in combination with a PD-1 antibody may lead to an enhanced anti-tumor immune response. The results from KEYNOTE-046 will determine the future clinical development program for the combination.
April 6, 2015
07:34 EDTADXSAdvaxis, RTOG Foundation collaborate on Phase 2/3 trial of ADXS-HPV
Advaxis announced that it is entering into a clinical trial collaboration agreement with the Radiation Therapy Oncology Group, or RTOG, Foundation to evaluate the safety and efficacy of Advaxis's lead cancer immunotherapy, ADXS-HPV, in a pivotal Phase 2/3 anal cancer trial, which will be run by NRG Oncology. ADXS-HPV is an investigational Lm-LLO immunotherapy bioengineered to generate an immune response to the HPV-associated tumor specific oncogene. Under the proposed collaboration, RTOG Foundation, through its partnership with NRG Oncology, will conduct an adequate and well-controlled Phase 2/3 clinical trial of concurrent chemotherapy of mitomycin C/5FU and radiation therapy, or CCRT, compared to CCRT combined with ADXS-HPV in the adjuvant treatment of high-risk locally advanced anal cancer.

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