Advaxis, Inc. : Advaxis to Report Updated Safety, Tumor Response, and Survival Data from a Phase 2 Trial in Recurrent/Refractory Cervical Cancer at ASCO

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."

The poster will be available on the Advaxis website at http://www.advaxis.com.

About ADXS-HPV

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 infect antigen-presenting cells and direct them to generate a powerful, cellular immune response to HPV E7. The resulting cytotoxic Tcells infiltrate and attack the tumors while specifically inhibiting tumor Tregs and MDSCs in the tumors that are protecting it.

The American Cancer Society estimates that there will be about 12,170 newly diagnosed cervical cancer cases in the U.S. in 2012. About 500,000 patients per year are diagnosed with high grade CIN (2-3), the predecessor condition to cervical cancer (source: Jones HW, Cancer 1995:76:1914-18; Jones BA and Davey, Arch Pathol Lab Med 2000; 124:672-81). In 2009, the CDC reported that about 45% of women aged 20 to 24 had HPV. HPV causes a number of different types of cancer. The same types of genital HPV that cause cervical cancer (HPV-16, HPV-18) cause about 8 out of 10 squamous cell anal cancers. In addition, nearly half of cancers of the vulva and about 7 out of 10 vaginal cancers are HPV-related. Some other genital cancers (cancers of the penis and urethra) and some head and neck cancers (mostly the throat, tongue, and tonsils) are also related to high-risk types of HPV. For additional information about HPV, 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.

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