Advaxis Low Dose Cohort 1 Meets 50% Efficacy Target In CIN 2/3

Mid dose Cohort 2 (6x higher dose) is 75% enrolled

PRINCETON, N.J.--(BUSINESS WIRE)--Feb 27, 2012 - 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.”

About ADXS-HPV Phase 2 Trial for CIN 2/3

This Phase 2 study is a randomized, single blind, placebo controlled study to assess the safety and efficacy of ADXS-HPV for the treatment of CIN 2/3. The study has three cohorts consisting of 40 patients each: 30 patients receive 3 doses of ADXS-HPV at 50 million7, 330 million or 1 billion cfu and 10 patients receive 3 doses of placebo. The primary objective of this study is to determine a safe dose of ADXS-HPV for the treatment of CIN 2/3. Efficacy is determined by an adjudicated panel of pathologists who are blinded to treatment and conduct microscopic assessments of the tissue removed at pretreatment biopsies and during their treatment surgery to determine if the lesions have regressed or returned to normal. Immunogenicity and HPV DNA data will be collected as well.

For more information, please visit Clinical Trials.gov, Identifier NCT01116245.

About Advaxis, Inc.

Advaxis is a clinical-stage biotechnology company developing the next generation of immunotherapies for cancer and infectious diseases. Advaxis immunotherapies are based on a novel platform technology using live, attenuated bacteria that are bio-engineered to secrete an antigen/adjuvant fusion protein that is designed to redirect the powerful immune response all human beings have to the bacterium to the cancer itself.

Advaxis' lead construct, ADXS-HPV, is being evaluated in 4 Phase 2 clinical trials that are open for enrollment for HPV-associated diseases: CIN 2/3 (US study, Clinical Trials.gov Identifier NCT01116245), locally advanced cervical cancer (GOG/NCI US study, Clinical Trials.gov Identifier NCT01266460), recurrent/refractory cervical cancer (India), and head & neck cancer (CRUK study). To date, over 390 doses of ADXS-HPV have been administered to over 160 patients. Over fifteen (15) distinct constructs are in various stages of development, developed directly by the Company and through strategic collaborations with recognized centers of excellence such as: the National Cancer Institute, Cancer Research – UK, the Wistar Institute, the University of Pennsylvania, the University of British Columbia, and others. For more information please visit: advaxis.com | Facebook | twitter | LinkedIn

Forward-Looking Statements

This news release contains forward-looking statements, including, but not limited to: statements as to the anticipated timing of clinical studies and other business developments, statements as to the development of new constructs, expectations as to the adequacy of our cash balances to support our operations for specified periods of time and as to the nature and level of cash expenditures, expectations as to market opportunities, our ability to take advantage of those opportunities, and the risk factors set forth from time to time in Advaxis' SEC filings, including but not limited to its report on Form 10-K for the fiscal year ended October 31, 2011, which is available at www.sec.gov. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. You are cautioned not to place undue reliance on any forward-looking statements.

 

Contact: Advaxis, Inc.
Diana Moore
Director, Investor Relations & Business Development
609-452-9814
dmoore@advaxis.com

 

 

Posted: February 2012

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