Advaxis receives India’s DCGI approval for ADXS11-001 Phase II clinical trial for cervical cancer

Aug 4 2010

Advaxis, Inc., (OTCBB: ADXS), the live, attenuated Listeria monocytogenes (Lm) immunotherapy company, has received formal permission from the Drugs Controller General India (DCGI) to conduct a Phase II clinical trial of ADXS11-001, the Company's flagship drug construct, among 110 women with advanced, metastatic cervical cancer that has progressed subsequent to treatment with cytotoxic therapy. 55 women will receive ADXS11-001 alone, 55 will receive a combined regimen of both ADXS11-001 and cytotoxic therapy.

“This design greatly advances the clinical development of ADXS11-001 in a number of ways”

Advaxis' Phase II clinical trial will provide a real-time survival assessment; making it possible to evaluate the effect of ADXS11-001 on survival compared to historical norms during the trial. Historically, even when given the most effective regimen tested to date, these patients had a median survival of approximately six (6) months with only five percent (5%) surviving one (1) year.

"This design greatly advances the clinical development of ADXS11-001 in a number of ways," said Dr. John Rothman, EVP of Science and Operations. "If we can duplicate the results of our Phase I or improve upon them with three (3) doses of our agent, and if we find our agent to improve the outcome in combination with chemotherapy, then we might be able to show ADXS11-001 to be a safe and effective therapeutic agent where no alternatives exist."