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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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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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