Advaxis (OTCBB: ADXS) Low Dose Cohort 1 Meets 50% Efficacy Target In CIN 2/3

Tallahassee, FL 2/27/12 (StreetBeat) -- Advaxis, Inc., (OTCBB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, has completed the first of 3 dose cohorts in the single blind, placebo controlled Phase 2 dose escalation study assessing the safety and efficacy of ADXS-HPV in the treatment of cervical intraepithelial neoplasia (CIN) 2/3. CIN 2/3 is the precursor to cervical cancer. Approximately 500,000 women in the U.S. are diagnosed with CIN 2/3 annually with most women requiring surgery to remove the lesion. The goal of this treatment is to prevent progression to cervical cancer and to eliminate the need for surgery and subsequent obstetric risks.

Results of Cohort 1:
• 52% of CIN 2/3 lesions regressed from CIN 2/3 to CIN 1 or normal in the ADXS-HPV arm. This means surgery is no longer required. The dose in cohort 1 is about 1/20th of the dose being used in trials of ADXS-HPV in cervical cancer.
• Achieving a 50% regression rate with the lowest dose tested is encouraging as The American Academy of Clinical Research’s Task Force on the Treatment and Prevention of Intraepithelial Neoplasia concluded that “…50% objective regression rate with a new treatment agent is considered clinically meaningful.” Further, “An improvement in CIN 2/3 to either pathologically normal cervix or of CIN 3 to CIN 1, with no new CIN 2/3 lesions appearing in at least 50% of the treated patients, is evidence of clinical benefit of the new agent.” (O’Shaughnessy, et al 2002, CCR, 8:314).
• 40% of CIN 2/3 lesions spontaneously regressed in the placebo arm. This is within the range reported in the scientific literature of 35%-43% (Wright, et. al. 2003. Am J Obstet Gynecol, Am. J. Obstet. Gynecol. 289:295).
• Less than 1/3 (29%) of the patients treated reported any side effects associated with treatment. Those that occurred were mild and self-resolved or responded quickly to treatment.
• No SAEs (serious adverse events) were reported.

This study is enrolling at several sites in the U.S. with a target enrollment of 120 patients across the 3 dose cohorts. Enrollment in cohort 2 (the mid dose) is 75% complete and is expected to report in early Q4 2012.

“This is an encouraging start to this study, especially at this low dose,” commented Dr. John Rothman, Executive Vice President of Science and Operations. “With cohort 2 dosage 6 times higher and cohort 3 dosage 20 times higher, we are anticipating higher response rates with continued safe administration.”

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