Advaxis to update preliminary data on 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, will update preliminary data on the safety and clinical benefit of ADXS-HPV from an ongoing randomized Phase 2 trial of ADXS-HPV with or without cisplatin in Indian women with recurrent/refractory cervical cancer who have failed cytotoxic therapy in a poster titled "ADXS11-001 immunotherapy targeting HPV-E7: Preliminary survival data from a phase II study in Indian women with recurrent/refractory cervical cancer" (Abstract #5106) at the 2012 American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago, IL, on Sunday, June 3, 2012. This study is being conducted at 22 sites in India and data will be presented on 109 out of the planned 110 patients enrolled as of May 18, 2012.    

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) to determine if ADXS-HPV can be safely administered in combination with platinum chemotherapy. The primary efficacy endpoint of this study is overall survival.

In preliminary data to be presented by Dr. Robert Petit, VP of Clinical Operations and Medical Affairs at Advaxis, as of May 18, 2012:

• 109 patients have received 255 doses of ADVS-HPV,
• The tolerability of ADXS-HPV compared favorably with single agent and combination chemotherapies active in this disease setting, with 36% of patients experiencing Grade 1-2 adverse events related/possibly related to ADXS-HPV and 0.9% experiencing a Grade 3 serious adverse event,
• Survival at 6, 9, and 12 months is 65%, 40%, and 31%, respectively.

While the primary clinical benefit expected from immunotherapy is overall survival (which may not be accompanied by tumor shrinkage), it is encouraging that objective tumor regressions in response to therapy have been observed. As of May 18, 2012 tumor responses per the RECIST 1.1 criteria have included:

• 4 complete responses (CR) - 2 in each treatment group,
• 5 partial responses (PR) - 2 in the ADXS-HPV group and 3 receiving ADXS+ cisplatin.

These updated data extend the preliminary data presented in January that reported 1 complete response and 3 partial responses.

Additionally, 56% of treated patients experienced disease control (complete response, partial response, or stable disease). Reductions in tumor burden were observed in patients infected with different "high risk" strains of HPV including HPV16, 18, 31, 33, 35, and 45.

"The tolerability of ADXS-HPV alone or in combination with chemotherapy, the objective tumor responses, and the effect upon survival in this late stage, poor prognosis patient population suggests that ADXS-HPV may have clinical utility and warrants further investigation," commented Dr. John Rothman, Executive Vice President of Science and Operations at Advaxis. "These preliminary data will change, as the study is ongoing. It is interesting to note that the various clinical patterns of response we have observed are similar to those observed for other immunotherapies that have been shown to be effective in treating cancer."