ADXS: Advaxis Collaborates with the GOG Foundation to Initiate a Phase III trial using ADXS-HPV in Cervical Cancer
Advaxis (ADXS), a clinical stage biopharmaceutical company, announced on January 7, 2015 that it has entered into an agreement with the GOG Foundation for the use of ADXS-HPV in cervical cancer. The GOG foundation is a non-profit entity that supports clinical research for the treatment of ovarian and other gynecologic cancers. The Phase III trial will evaluate the safety and efficacy of ADXS-HPV, which has been designed to elicit an immune response to HPV expressing tumors such as cervical cancer. The Company’s previous Phase II trial in cervical cancer yielded encouraging results and supported the transition into this Phase III study.
The GOG Foundation and Advaxis will design and conduct the Phase III trial using ADXS-HPV in parallel with chemotherapy and radiotherapy (CCRT) compared to the combination of ADXS-HPV and CCRT. Advaxis intends to discuss the Phase III program with the FDA prior to initiation and respond quickly to any questions or concerns the agency may have regarding the trial. In addition, Advaxis will request a Special Protocol Assessment (SPA), a declaration that states the current trial design is adequate for approval.
We welcome the initiation of this trial as it’s the Company’s first Phase III in its pipeline. The backing of the GOG Foundation not only helps validate the technology, but also provides the expertise of the organization’s world renowned experts to ensure adequate trial design and implementation which may increase the chances of a positive outcome. It is estimated that 12,000 women will develop cervical cancer as a result of HPV (human papilloma virus) this year alone in the US. Advaxis has the potential to become the leader in treating HPV associated cancers with an estimated $500 million market in US for cervical cancers alone.
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