PRINCETON, N.J.--(BUSINESS WIRE)-- Advaxis, Inc., (OTCBB: ADXS) (Advaxis or the Company), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced that the first patient has been dosed in a Phase 1/2 study of ADXS-HPV in 25 patients with HPV-associated anal cancer coordinated by the Brown University Oncology Research Group (BrUOG).
This study will expand the clinical investigation of ADXS-HPV to now a third tumor type, following cervical cancer and head and neck cancer.
This non-randomized, open-label, multi-center study will evaluate the safety and effectiveness of ADXS-HPV when combined with standard chemotherapy and radiation treatment for anal cancer. The primary objectives of the trial include the evaluation of adverse events and the evaluation of 6-month clinical response.
This milestone marks the beginning of the development of ADXS-HPV in diseases beyond cervical cancer. It also will provide valuable insight into the combination of ADXS-HPV with concurrent radiation and chemotherapy, commented Dr. Robert Petit, VP of Clinical Operations and Medical Affairs at Advaxis (ADXS.OB).
About ADXS-HPV for Anal Cancer
Virtually all cases of squamous cell cancer (SCC) of the anus are caused by a Human Papilloma Virus (HPV) infection. Anal cancer cells infected with HPV have the tumor associated antigen HPV E7. ADXS-HPV causes antigen presenting cells to stimulate other immune cells to attack cancer expressing HPV E7. In Phase 1 clinical trials and preliminary data from ongoing Phase 2 trials, ADXS-HPV has been safely administered to 194 patients with other HPV-associated diseases (recurrent/refractory cervical cancer and CIN 2/3), and has demonstrated clinical benefit as a single agent or in combination with chemotherapy.
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.
ADXS-HPV is being evaluated in 5 clinical trials for HPV-associated diseases: recurrent/refractory cervical cancer (India), locally advanced cervical cancer (GOG/NCI US study, Clinical Trials.gov Identifier NCT01266460), CIN 2/3 (US study, Clinical Trials.gov Identifier NCT01116245), head & neck cancer (CRUK study, Clinical Trials.gov Identifier NCT01598792), and anal cancer (BrUOG study, Clinical Trial.gov Identifier NCT01671488). 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 regarding ADXS-HPV, its clinical stage product candidate, and immunotherapies, and their effect on cancer, such as statements regarding the development of ADXS-HPV for diseases beyond cervical cancer, and statements regarding potential insight into the combination of ADXS-HPV with concurrent radiation and chemotherapy, as well as statements as to the development of new constructs. Such forward-looking statements are subject to a number of risks and uncertainties, such as those described in the Risk Factors section in Advaxis Annual Report on Form 10-K for the fiscal year ended October 31, 2012, which is available at www.sec.gov, as well as its other filings with the Securities and Exchange Commission. Advaxis undertakes no obligation to revise these forward-looking statements 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
Source: Advaxis, Inc.Copyright Business Wire 2013