PRINCETON, N.J.--(BUSINESS WIRE)--
Advaxis, Inc., (ADXS) (“Advaxis” or the “Company”), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, reports encouraging preliminary data from the Phase 1 dose escalation study evaluating the safety of ADXS-cHER2 in companion dogs with Her2/neu overexpressing canine osteosarcoma being conducted at the University of Pennsylvania School of Veterinary Medicine.
The primary endpoint of the study is to determine the maximum tolerated dose of ADXS-cHER2. Preliminary data from the first two dose groups (3 dogs each) show that ADXS-cHER2 at either 1 x 108 or 5 x 108 cfu is well-tolerated. 100% of dogs experienced 1 or more mild (Grade 1) side effects consistent with cytokine release syndrome observed at the time of administration (fever, increased blood pressure, malaise, nausea, and/or vomiting). Early data also suggest that Her2/neu expression in canine osteosarcoma may denote a more aggressive phenotype.
Secondary endpoints for the study are progression-free survival and overall survival. Early results from the first two dose groups (6 dogs) show a significant survival advantage in dogs that received ADXS-cHER2 compared to 6 dogs whose owners elected not to participate in the trial but who were followed for survival (p=0.01).
Dr. Nicola Mason, lead investigator in the Penn canine osteosarcoma study, plans to expand the trial to three additional sites in the United States. ADXS-cHER2 booster vaccinations will be given to evaluate the effects of maintenance immunotherapy.
“The preliminary data from this study are encouraging,” commented Dr. Nicola Mason. “The dogs that have been treated with ADXS-cHER2 are doing very well and although the numbers of vaccinated dogs are small, they do appear to be doing better than dogs with Her2/neu overexpressing tumors that did not receive the vaccine. I am extremely excited to expand this trial, make the vaccine available to more dogs, and determine its therapeutic benefit in dogs with this highly aggressive tumor type.”
“These preliminary findings suggest that the second Advaxis immunotherapy to be evaluated in a clinical setting (in addition to ADXS-HPV) may also improve survival in cancer. Furthermore, a veterinary oncology indication could potentially open an entirely new market for Advaxis Lm-LLO immunotherapies and further validates the versatility of our technology platform and constructs,” commented Thomas A. Moore, Chairman and Chief Executive Officer of Advaxis.
About Canine Osteosarcoma
Canine osteosarcoma, a cancer of the long (leg) bones, affects approximately 8,000 dogs a year in the United States and is a leading killer of large dogs over the age of 10 years. Standard treatment is amputation immediately after diagnosis, followed by chemotherapy. Invariably, however, the cancer metastasizes to the lungs. With chemotherapy, dogs survive about 18 months compared to 6-12 months, without treatment.
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 Trials.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-cHER2, its clinical stage product candidate, and immunotherapies, and their effect on cancer (including survival rates), and statements regarding plans to expand the canine osteosarcoma trial, statements regarding the administration of booster vaccinations of ADXS-cHER2, and statements as to the therapeutic benefit of the treatment, as well as potential new markets for Lm-LLO immunotherapies. 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.
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Diana Moore, 609-452-9814
Director, Investor Relations & Business Development