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June 16, 2014
08:58 EDTADXSAdvaxis evaluated higher dose, repeat cycles of ADXS-HPV in Phase 1/2 trial
Advaxis announced that the Georgia Regents University, or GRU, Cancer Center has received Institutional Review Board, or IRB, approval to initiate a Phase 1/2 trial evaluating higher doses and repeat cycles of ADXS-HPV in patients with recurrent cervical cancer. The trial will be conducted at GRU under the direction of Dr. Samir Khleif, Director, GRU Cancer Center. ADXS-HPV is Advaxis's lead Lm-LLO cancer immunotherapy product candidate, designed to target HPV-associated cancers. This Phase 1/2 study is designed to evaluate the safety, efficacy and immunological effect of the highest-tolerated dose of ADXS-HPV administered in repeat cycles of treatment to patients with cervical cancer whose disease recurred after receiving one prior cytotoxic treatment regimen. Advaxis's earlier Phase 2 clinical study in 110 women with recurrent cervical cancer had already demonstrated that a single cycle of ADXS-HPV at a dose of 1x109 colony forming units, or CFU, is well-tolerated with complete and partial tumor responses as well as an apparent survival benefit. Building on this data, among the purposes of this study is to evaluate the effect of repeat cycles of treatment of ADXS-HPV at higher doses.
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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