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News Breaks
February 5, 2014
07:49 EDTADXSAdvaxis to conduct 4 cancer immunotherapy clinical trials with GRU Cancer Center
Advaxis announced it has expanded its relationship by entering into a master clinical trial agreement with GRU Cancer Center to conduct four Phase 1/2 clinical trials. The planned trials will further develop Advaxis' two lead immunotherapies: ADXS-HPV for cervical cancer and ADXS-cHER2 for breast cancer. The planned trials will further develop Advaxis' two lead immunotherapies: ADXS-HPV for cervical cancer and ADXS-cHER2 for breast cancer. The four clinical trials will be designed to assess: High dose, repeating cycles of ADXS-HPV in recurrent or refractory cervical cancer. ADXS-cHER2 in women with Her2/neu over-expressing breast cancer with measurable disease who have progressed after prior standard therapy. The optimal combination dose of ADXS-HPV and PD-1 antibody in patients with recurrent or refractory cervical cancer. ADXS-HPV prior to surgery in patients with surgically treatable cervical cancer.
News For ADXS From The Last 14 Days
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January 30, 2015
09:09 EDTADXSAdvaxis to host analyst and investor day
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January 28, 2015
07:33 EDTADXSAdvaxis Phase 2 study achieves safety, efficacy criteria
Advaxis announced an update related to the Phase 2 open-label clinical study of ADXS-HPV in patients with persistent or recurrent cervical cancer with documented disease progression being conducted by the Gynecologic Oncology Group, or GOG, now part of NRG Oncology. The study, known as GOG 0265, has completed its first stage and has met the predetermined safety and efficacy criteria required to proceed into the second stage of patient enrollment. This trial is being conducted in the U.S. by the GOG, under the sponsorship of the Cancer Therapy Evaluation Program, or CTEP, of the National Cancer Institute, or NCI. GOG 0265 is an open-label, single arm 2-stage study designed to evaluate the safety, tolerability and efficacy of ADXS-HPV in approximately 67 patients. Patients receive one cycle of ADXS-HPV at 1 x 109 cfu every 28 days. The primary efficacy endpoint is 12-month survival, with secondary efficacy endpoints of progression-free survival, overall survival and objective tumor response. The primary safety endpoints are the number of patients with dose-limiting toxicities and the frequency and severity of adverse effects. Stage 1 enrolled 29 patients and stage 2 is set to enroll another 38. Further information about GOG 0265 can be found on ClinicalTrials.gov, using Identifier NCT01266460.
January 27, 2015
10:01 EDTADXSAdvaxis strength due to more than stock promotion, TheStreet says
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January 22, 2015
11:04 EDTADXSAdvaxis announces FDA acceptance of IND application to conduct Phase 1 trial
Advaxis (ADXS) announced that the U.S. FDA has cleared its Investigational New Drug application to conduct a Phase 1 clinical study of ADXS-HER2 for the treatment of patients with metastatic HER2 expressing solid tumors. The clinical trial, which will be the first-in-human study of Advaxis's lead Lm-LLO immunotherapy product for HER2 expressing cancers, is expected to begin patient enrollment in the first half of 2015. In May 2014, Advaxis was granted orphan drug designation by the FDA for ADXS-HER2 in osteosarcoma.The Phase 1 clinical study is designed to evaluate the safety and tolerability of ADXS-HER2 as a monotherapy in patients with metastatic HER2 expressing solid tumors such as breast, gastric, esophageal, and osteosarcoma. Results from the study will be used to determine the future clinical development program of ADXS-HER2. The safety and efficacy of ADXS-HER2 is currently being evaluated in an ongoing Phase 1/2 veterinary clinical study in pet dogs with osteosarcoma, conducted by Nicola Mason, BVet.Med, Ph.D., DACVIM, of the University of Pennsylvania School of Veterinary Medicine. To date, dogs treated with ADXS-HER2 immunotherapy, after receiving standard of care had a statistically significant overall survival benefit compared to dogs that only received standard of care. Additionally, the preliminary data suggests immune responses induced by ADXS-HER2 targeted pulmonary micrometastases and prevent the development of metastatic disease in the dog's lungs.Advaxis has granted exclusive worldwide rights to Aratana Therapeutics (PETX) to develop and commercialize ADXS-HER2 for the treatment of osteosarcoma in dogs. In July 2014, Aratana filed a U.S. Department of Agriculture product license application for ADXS-HER2 for the treatment of canine osteosarcoma and other cancers. While the USDA has no specific obligation to respond within a prescribed timeframe, the companies expect a response within 12 to 18 months from the date the application was filed.
January 21, 2015
10:26 EDTADXSHigh option volume stocks
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09:32 EDTADXSAdvaxis mentioned cautiously by Seeking Alpha contributor
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January 20, 2015
10:06 EDTADXSHigh option volume stocks
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