Advaxis reports continued positive patient survival pattern in ADXS-HPV Phase 2 cervical cancer trial

Advaxis, Inc., (OTCBB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, presented updated preliminary data from an ongoing randomized Phase 2 trial of ADXS-HPV being conducted in India in women with recurrent/refractory cervical cancer who have failed previous cytotoxic therapy. These data were reported on Thursday, July 26, 2012 at the Immunotherapy Subcommittee Workshop of the Gynecologic Oncology Group (GOG) meeting in Boston. The GOG is conducting a Phase 2 study of ADXS-HPV in a similar patient population in the US.

“We are pleased to observe a continued positive pattern in patient survival and objective tumor responses as the study continues and the data mature”

The objectives of this Phase 2 trial include an assessment of the safety and efficacy of ADXS-HPV (1x10⁹ cfu) with and without cisplatin (40 mg/m², weekly x5). The primary endpoint of this study is survival.

As of July 12, 2012, survival at 6, 9, and 12 months is 64%, 46%, and 29%, respectively. This compares to survival of 65%, 40%, and 31% that was reported at the 2012 ASCO Annual Meeting in June. National Comprehensive Network Guidelines cite historical 12 month survival data of 0-22% with single agent therapy in this patient population.

Objective tumor responses and stable disease continue to be observed in the India trial. As of July 12, 2012, 63 patients had survived at least 3 months and had at least one follow up CAT scan to determine tumor response. Tumor responses included:

• 5 complete responses (CR): 3 in the ADXS alone group; 2 in the ADXS+ cisplatin group.
• 6 partial responses (PR): 3 in the ADXS alone group; 3 in the ADXS+ cisplatin group.

A complete response is defined as 100% elimination of tumor burden. A partial response is defined as 30% or more reduction in tumor burden. In June 2012, Advaxis reported 4 complete responses and 5 partial responses.

"We are pleased to observe a continued positive pattern in patient survival and objective tumor responses as the study continues and the data mature," commented Dr. Robert Petit, Vice President of Clinical Operations and Medical Affairs. "These women have cancer that has recurred after receiving conventional treatments and they face a very poor prognosis. Tumor responses to ADXS-HPV in cervical cancer have occurred in patterns characteristic of those observed with effective immunotherapies for other cancers. Cervical cancer is the second leading cause of cancer death among women, and the leading cause of cancer death in women under 45, worldwide."