Advaxis Completes Enrollment in Phase 2 Cervical Cancer Study
PRINCETON, N.J., May 29, 2012 (BUSINESS WIRE) -- Advaxis, Inc. a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced today that it has completed enrollment in Lm-LLO-E7-15, the 110 patient, randomized Phase 2 trial of ADXS-HPV in women with recurrent/refractory cervical cancer who have failed cytotoxic therapy. The trial is designed to assess if ADXS-HPV can be safely administered in combination with and without cisplatin chemotherapy. The primary endpoint of this trial is overall survival.
Updated preliminary data from this study will be presented at the 2012 American Society of Clinical Oncology (ASCO) Annual Meeting to be held in Chicago, IL, June 1-5, 2012. The poster entitled "ADXS11-001 immunotherapy targeting HPV-E7: Preliminary survival data from a phase II study in Indian women with recurrent/refractory cervical cancer" (Abstract #5106) will be presented during the Gynecological Cancer Poster Session on Sunday, June 3, 2012 from 8:00 a.m. -- 12:00 p.m. in S Hall A2.
This study is being conducted at 22 sites in India. All patients randomized to the trial have been previously treated with chemotherapy, radiotherapy or both, and their cancer has progressed subsequent to treatment and has been confirmed by CT or radiologic scan.
"Completing enrollment of patients in this study is a major milestone in the clinical development program for our initial construct, ADXS-HPV, and for the Company," commented Dr. John Rothman, EVP of Science & Operations. "The preliminary data being reported from the India trial continue to support a well-tolerated safety profile as well as clinical benefit in a portion of the patients. We look forward to announcing additional data at ASCO."
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.
SOURCE: Advaxis, Inc.
Diana Moore, 609-452-9814
Director, Investor Relations & Business Development