PRINCETON, N.J.--(BUSINESS WIRE)--Advaxis, Inc., (OTCBB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced that two patients have been enrolled into REALISTIC, a Phase 1/2 study being sponsored by Cancer Research UK (CRUK) to investigate the use of ADXS-HPV for the treatment of HPV positive head and neck cancer. HPV is associated with 40-70% of head and neck cancers.
This trial is being conducted at the Aintree Hospital at the University of Liverpool, the Royal Marsden Hospital at the University of London, and the Cardiff Hospital at the University of Wales. The study will investigate the safety and efficacy of this novel immunotherapeutic agent in preventing recurrence of head and neck cancer among patients who have been treated with surgery, radiotherapy, and/or chemotherapy; alone or in combination. A maximum of 45 patients are to be enrolled in this study, and all costs will be assumed by CRUK. Two patients have already been enrolled in the trial at the Aintree Hospital in Liverpool, UK.
Thomas A. Moore, Chairman & CEO of Advaxis commented, “We are pleased to be working with an internationally-renowned oncology group to further expand the ADXS-HPV clinical development program to another HPV-associated tumor type. Through this collaboration, we hope that our proprietary technology will be able to offer a new treatment option to patients suffering from the recurrence of head and neck cancer, an important unmet medical need.”
According to the National Cancer Institute and the American Cancer Society, head and neck cancers represent approximately 3 percent of all cancers in the United States and are twice as common in men as in women. Historically, head and neck cancer has been associated with people over the age of 50 and with the use of alcohol and tobacco (including smokeless tobacco), however, there has been a recent rise in HPV-related oropharyngeal cancers in caucasian men under the age of 50. Recurrence rates in patients are high, in some studies over 80% within 2 years (Source: Risk factors for local-regional recurrence following preoperative radiation therapy and surgery for head and neck cancer (stage II-IVB), Shikama N, et al. Radiology. 2003 Sep; 228(3):789-94).
About Cancer Research UK
Cancer Research UK is the largest single funder of cancer research in the UK and the world’s largest charity dedicated to cancer research. It funds research on all aspects of cancer, from basic cell biology to large clinical studies of entire populations. The organization funds the work of more than 4,500 scientists, doctors, and nurses across the UK and runs specialized institutes dedicated to cancer research. Cancer Research UK currently funds more than 180 clinical trials.
Since the early 1980s, Cancer Research UK has taken over 100 new drugs into clinical trials with more than 100,000 patients taking part in trials since 1995.
For more information, please visit: www.cancerresearchuk.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.
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). 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.