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PRINCETON, N.J., Jan. 25 — Advaxis, Inc., (OTCBB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, reported 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. Dr. John Rothman, Advaxis Executive Vice President of Science and Operations, presented the preliminary data at the World Cancer Immunotherapy Conference in San Diego, California on Wednesday, January 25, 2012.
The advanced cervical cancer study is being conducted at 17 sites in India, and as of January 25, 2012, 87 out of a planned 110 patients have been enrolled in the study. To be enrolled in the study, all patients must have been previously treated with radiation, and/or chemotherapy, and the cancer must have resumed growth and in most cases has metastasized, as confirmed by CT or radiologic scan. Because data are available to Advaxis in “real time”, the Company is reporting preliminary data on a periodic basis. The initial safety and objective response data for this ongoing study were presented at the AACR New Horizons in Cancer Research: Biology to Prevention to Therapy conference Gurgaon, Delhi (NCR), India on December 14, 2011.
The objectives of this Phase 2 trial are to assess the safety and efficacy of ADXS-HPV (1×109 cfu) with and without cisplatin (40 mg/m2) and to determine if ADXS-HPV can be safely administered in combination with platinum chemotherapy. As of January 20, 2012, 87 patients have received 195 doses of ADVS-HPV. 34% of patients (a total of 30) have experienced a ADXS-HPV drug-related adverse event, consisting of Grade 1 or 2 events that were transient, comprised of non-cumulative flu-like symptoms that responded to symptomatic treatment, or resolved on their own; and 1 Grade 3 event.
The primary efficacy endpoint of this Phase 2 trial is overall survival. As of January 25, 2012, the percentage of patients alive at 6 months is 62% (34/55); at 9 months is 41% (15/37) and at 1 year is 40% (6/15). Clinical responses have been observed in both treatment arms with 3 complete responses (elimination of tumor burden) and 4 partial responses (≥30% reduction in tumor burden) documented to date, which expands on the preliminary data presented at the AACR meeting in December that reported 1 complete response and 3 partial responses. “These data will change, as the study is ongoing and still enrolling. However, we are encouraged by the preliminary safety, tumor response, and survival data,” commented Dr. Rothman.
The slide presentation is available on the Advaxis website at http://www.advaxis.com/.
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 designed to redirect the powerful immune response all human beings have to the bacterium to the cancer itself.
Advaxis’ most advanced construct, ADXS-HPV, is being evaluated in 4 Phase 2 clinical trials 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) with over 150 patients receiving over 360 doses to date. 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, and others.