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news.Advaxis, a clinical-stage biotechnology company, has completed patient enrollment in Phase II trial of ADXS-HPV in women with recurrent/refractory cervical cancer who have failed cytotoxic therapy.
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Patients with chemotherapy, radiotherapy or both, and whose cancer has progressed to treatment and has been confirmed by CT or radiologic scan, were randomized to the trial.
Advaxis Science and Operations EVP John Rothman said, "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."
The 110 patient randomized trial is designed to evaluate the safety of ADXS-HPV in combination with and without cisplatin chemotherapy.
The overall survival is the primary endpoint of the trial that is being conducted at 22 sites in India.