Advaxis Reports Updated Phase 2 Cervical Cancer Trial Data at NCI/GOG Meeting
Additional Tumor Reductions Observed
PRINCETON, N.J.--(BUSINESS WIRE)--Jul 30, 2012 - 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.
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.”
ADXS-HPV is an immunotherapy that is designed to target cells expressing the HPV gene E7. Expression of the E7 gene from high-risk HPV variants is responsible for the transformation of infected cells into dysplastic and malignant tissues. Eliminating these cells can eliminate the dysplasia or malignancy. ADXS-HPV is designed to direct antigen-presenting cells to generate powerful innate and cellular immune responses to HPV transformed cells. The resulting cytotoxic T cells infiltrate and attack the tumors while inhibiting immunosuppressive tumor Tregs and MDSCs in the tumors that are protecting tumors from immune attack.
The American Cancer Society estimates that there will be about 12,170 newly diagnosed cervical cancer cases in the U.S. in 2012, of which more than 99% are due to infection with HPV. About 500,000 patients per year are diagnosed with high grade CIN (2-3), the predecessor condition to cervical cancer. HPV causes a number of different types of cancer, including anal, vulvar, vaginal, head and neck, and other genital cancers. For additional information about HPV, please visit the American Cancer Society website.
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
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
Posted: July 2012
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