Advaxis completes patient enrollment in phase II cervical cancer study
Advaxis Inc., a leader in developing the next generation of immunotherapies for cancer and infectious diseases, has completed enrollment of 110 patient in Lm-LLO-E7-15, randomized phase II 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 updated preliminary data from this study will be presented at the 2012 American Society of Clinical Oncology (ASCO) Annual Meeting June 1-5, 2012 in Chicago, Illinois. The primary endpoint of this trial is overall survival.
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 programme 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.”