Advaxis Updates Phase 2 Cervical Cancer Trial Data
Advaxis, Inc., (OTCBB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, updated preliminary data from an ongoing randomized 110 patient Phase 2 trial of ADXS-HPV being conducted in India in women with recurrent/refractory cervical cancer who have failed previous cytotoxic therapy. Dr. Robert Petit, Advaxis, presented the update in an oral presentation on Saturday, October 27, 2012 at the Society for Immunotherapy of Cancer (SITC) 27th Annual Meeting in North Bethesda, MD.
This Phase 2 trial assesses the safety and efficacy of ADXS-HPV (1x109 cfu) alone, compared to ADXS-HPV plus cisplatin (40 mg/m2, weekly x5). There are 55 patients in each group.
The primary endpoint of the study is overall survival. As of October 22, 2012, landmark survival at 6, 9, 12, and 18 months was 65%, 44%, 33%, and 17% respectively. There appears to be no difference in survival between the two groups.
The National Comprehensive Cancer Network Guidelines cite historical 12 month survival data of 0-22% with single agent therapy in recurrent cervical cancer. This study shows 12 month survival of 33% among a group of 70 patients.
6 complete (100%) responses and 6 partial (30%+) responses have been reported, an increase of one complete response since our July report.
- 6 complete responses (CR): 4 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.
After 110 patients and 264 doses, the safety data is encouraging. ADXS-HPV continues to demonstrate a well-tolerated and manageable safety profile with 32% of patients reporting Grade 1 or 2 transient, flu-like symptoms that self-resolve or respond to symptomatic treatment. Less than 2% of patients reported serious adverse events associated with ADXS-HPV. Published studies on chemotherapy treated patients like these show 100% of patients experiencing severe adverse events, usually multiple times. Serious adverse events result in death, are life-threatening, cause significant disability or require inpatient hospitalization.
“This study is now well advanced, as evidenced by the fact that the majority of patients have been in the study for more than 12 months and we are reporting 18 month landmark survival data for the first time. ADXS-HPV appears to be emerging as an active agent in recurrent/refractory cervical cancer with significantly less toxicity than chemotherapy. Apparent prolonged survival, durable complete and partial tumor reductions, and stable disease have been observed in both treatment groups,” commented Dr. Robert Petit, Vice President of Clinical Operations and Medical Affairs at Advaxis.
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 directs 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 antigen/adjuvant fusion protein(s) 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 ongoing clinical trials that are open to 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.
Diana Moore, 609-452-9814
Director, Investor Relations & Business Development