Enrollment complete in Advaxis’ ADXS-HPV Phase 2 trial for cervical cancer

Advaxis, Inc., (OTCBB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced today that it has completed enrollment in Lm-LLO-E7-15, the 110 patient, randomized Phase 2 trial of ADXS-HPV in women with recurrent/refractory cervical cancer who have failed cytotoxic therapy. The trial is designed to assess if ADXS-HPV can be safely administered in combination with and without cisplatin chemotherapy. The primary endpoint of this trial is overall survival.    

Updated preliminary data from this study will be presented at the 2012 American Society of Clinical Oncology (ASCO) Annual Meeting to be held in Chicago, IL, June 1-5, 2012. The poster entitled "ADXS11-001 immunotherapy targeting HPV-E7: Preliminary survival data from a phase II study in Indian women with recurrent/refractory cervical cancer" (Abstract #5106) will be presented during the Gynecological Cancer Poster Session on Sunday, June 3, 2012 from 8:00 a.m. - 12:00 p.m. in S Hall A2.

This study is being conducted at 22 sites in India. All patients randomized to the trial have been previously treated with chemotherapy, radiotherapy or both, and their cancer has progressed subsequent to treatment and has been confirmed by CT or radiologic scan.

"Completing enrollment of patients in this study is a major milestone in the clinical development program for our initial construct, ADXS-HPV, and for the Company," commented Dr. John Rothman, EVP of Science & Operations. "The preliminary data being reported from the India trial continue to support a well-tolerated safety profile as well as clinical benefit in a portion of the patients. We look forward to announcing additional data at ASCO."