Advaxis ADXS-PSA Construct Causes Significant Tumor Regression in Preclinical Prostate Cancer Study

PRINCETON, N.J.--(BUSINESS WIRE)--Jun 13, 2012 - Advaxis, Inc., (OTCBB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced the publication of preclinical research with ADXS-PSA (ADXS31-142), Advaxis' Lm-LLO immunotherapy targeting the PSA antigen associated with prostate cancer.

This research was conducted in collaboration with Dr. Chandan Guha and his laboratory at Montefiore Medical Center, Bronx, NY. The paper titled “Combined immunotherapy with Listeria monocytogenes-based PSA vaccine and radiation therapy leads to a therapeutic response in a murine model of prostate cancer” by Hannan R, Zhang H, Wallecha A, Singh R, Liu L, Cohen P, Alfieri A, Rothman J, and Guha C., has been e-published ahead of print in the journal Cancer Immunology Immunotherapy.

The objective of the study was to determine if the combination of ADXS-PSA immunotherapy and radiation therapy could improve upon the efficacy of either immunotherapy alone or radiation therapy alone in the treatment of mice bearing PSA-expressing TPSA23 tumors, a preclinical model of prostate cancer.

The study showed:

 

  • The combination of ADXS-PSA immunotherapy and radiation therapy resulted in complete regression of established tumors in 60% of mice compared to ‰¤ 10% complete regression in either of the treatments alone.
  • In mice that completely regressed after combination therapy, tumors did not develop upon re-challenge with tumor cells, suggesting the induction of systemic and protective immune memory.
  • In addition, combination therapy resulted in increased induction of PSA-specific T cells in the periphery and an increased infiltration of these cells in the tumor microenvironment.

“ADXS-PSA continues to demonstrate activity in models of prostate cancer, confirming our decision to move this construct into clinical development. The potential synergy of ADXS-PSA and radiotherapy observed in this study suggests that ADXS-PSA might be combined with other therapies that show efficacy in this type of tumor,” commented Dr. John Rothman, EVP of Science and Operations at Advaxis.

The abstract is available online.

About ADXS-PSA

ADXS-PSA is an immunotherapy that is designed to target the PSA antigen associated with prostate cancer. This agent is based on Advaxis proprietary technology and uses a non-pathogenic live attenuated strain of Listeria monocytogenes to express a fusion protein of PSA joined to a non-toxic fragment of the adjuvant Listeria protein listeriolysin O (tLLO). By incorporating this PSA-tLLO antigen-adjuvant protein into the Advaxis live, attenuated vector, the agent delivers potent immune stimulation directed against a prostate cancer specific antigen directly from inside antigen presenting cells that are capable of driving a cellular immune response to PSA expressing cells. Uniquely, Advaxis Lm-LLO technology also inhibits Treg and MDSC cells within the tumor microenvironment that promote immunologic tolerance of the prostate cancer cells of the tumor.

According to the American Cancer Society, prostate cancer is the most common type of cancer found in American men, other than skin cancer. Prostate cancer is the second leading cause of cancer death in men, behind only lung cancer. One man in six will get prostate cancer during his lifetime, and one man in 36 will die of this disease. For additional information about prostate cancer, please visit: http://www.cancer.org/.

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.

In April 2012, Advaxis' lead construct, ADXS-HPV, was selected as the Best Therapeutic Vaccine (approved or in development) at the 5th Annual Vaccine Industry Excellence (ViE) Awards by the vaccine industry and the journal Expert Reviews of Vaccines. The ViE awards, sponsored by Novartis Vaccines and Diagnostics, were created to recognize the accomplishments and contributions of companies and individuals in the vaccine industry over the previous 12 months. Additional information is available at the World Vaccine Congress website.

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, Clinical Trials.gov Identifier NCT01598792). 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, the Karolinska Institutet, 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, 609-452-9814
Director, Investor Relations & Business Development
dmoore@advaxis.com
or
Media:
Russo Partners
Matt Middleman, M.D.
David Schull
T: 212-845-4272
T: 212-845-4271
matt.middleman@russopartnersllc.com
david.schull@russopartnersllc.com

 

 

Posted: June 2012

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