PRINCETON, N.J., June 6, 2014 (GLOBE NEWSWIRE) -- Advaxis, Inc. (Nasdaq:ADXS), a biotechnology company developing cancer immunotherapies, announced that principal investigator, Nicola Mason, B.Vet. Med, PhD, DACVIM, of the University of Pennsylvania School of Veterinary Medicine, presented updated data from the ongoing ADXS-cHER2 study in canine osteosarcoma at the 2014 American College of Veterinary Internal Medicine (ACVIM) Forum in Nashville, TN. ADXS-cHER2 is an immunotherapy that targets the HER2 receptor, which is overexpressed in certain solid-tumor cancers, including canine and human bone cancer and breast cancer.
The preliminary findings of the Phase 1 clinical trial in dogs with osteosarcoma suggest that ADXS-cHER2 is safe and well tolerated at doses up to 3 x 109 CFU with no evidence of cardiac, hematological, or other systemic toxicities. The study determined that ADXS-cHER2 is able to delay or prevent metastatic disease and significantly prolong overall survival in dogs with osteosarcoma that had minimal residual disease following standard of care (amputation and follow-up chemotherapy). At the time of Dr. Mason's presentation, 80% of the dogs treated (n=15) were still alive and median survival had not yet been reached; median survival in control dogs (n=13) was 316 days. Immunological analyses are also being conducted in this study to further evaluate the immune response to ADXS-cHER2.
Dr. Mason commented, "This work builds on a growing body of evidence that osteosarcoma is an immune responsive tumor and indicates that immune targeted therapies, such as ADXS-cHER2, can significantly change the prognosis for dogs diagnosed with this disease, as well as additional cancers where HER2 is over expressed."
Dr. Mason is conducting a second study evaluating combination therapy with ADXS-cHER2 immunotherapy and radiation for dogs with primary osteosarcoma that cannot undergo amputation.
Earlier this year, Advaxis granted exclusive worldwide rights to Aratana Therapeutics (Nasdaq:PETX) to develop and commercialize ADXS-cHER2 for the treatment of osteosarcoma in dogs. Recently, ADXS-cHER2 was granted orphan drug status for the treatment of human osteosarcoma by the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD).
Daniel J. O'Connor, Chief Executive Officer of Advaxis, remarked, "The compelling data from Dr. Mason's research in canine osteosarcoma affirms our decision to first pursue a clinical development program with ADXS-cHER2 in pediatric osteosarcoma, given that HER2/neu is over-expressed in more than 40% of children with osteosarcoma. Based on the similarities between canine and human osteosarcoma, and the limited availability of new treatment options for pediatric osteosarcoma, we believe that ADXS-cHER2 may be a promising immunotherapy that could have the potential to improve outcomes and quality of life for this high unmet medical need. We also plan to further develop ADXS-cHER2 in other HER2 overexpressing cancers such as breast, gastric and esophageal."
About Advaxis, Inc.
Advaxis is a clinical-stage biotechnology company developing multiple cancer immunotherapies based on its proprietary platform intended to redirect the immune system to kill cancer. The Advaxis technology, using bioengineered live attenuated bacteria, is the only known cancer immunotherapy shown in preclinical studies to neutralize Tregs and MSDCs, that protect the tumor microenvironment from immunologic attack and contribute to tumor growth. Advaxis's lead immunotherapy, ADXS-HPV, targets human papillomavirus (HPV)-associated cancers and is in clinical trials for three indications: Phase 2 in invasive cervical cancer, Phase 1/2 in head and neck cancer, and Phase 1/2 in anal cancer. The FDA has granted Advaxis orphan drug status for each of these three indications. The Company plans to initiate a registrational clinical program for cervical cancer in 2014 and has established licensing partners in India and Asia for commercialization in those regions. Advaxis's second immunotherapy candidate is ADXS-PSA, which is being developed to address prostate cancer. Advaxis is planning to file an IND with the FDA and initiate a Phase 1 clinical study with ADXS-PSA in 2014. Advaxis is also developing ADXS-cHER2, to target the HER2 receptor, which is overexpressed in certain solid-tumor cancers, including pediatric bone cancer (or osteosarcoma), breast cancer, and gastric cancer. Advaxis is developing ADXS-cHER2 for both human and animal-health, and has seen promising results in canine osteosarcoma, a model for human bone cancer. Advaxis is pursuing a clinical program in pediatric osteosarcoma and has licensed ADXS-cHER2 and three other immunotherapy constructs to a major animal-health company. Advaxis is planning to file an IND for ADXS-cHER2 in HER2 overexpressing cancers.
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This news release contains forward-looking statements, including, but not limited to: statements regarding Advaxis' ability to develop the next generation of cancer immunotherapies; the safety and efficacy of Advaxis' proprietary immunotherapy, ADXS-HPV; whether higher doses and multiple treatment cycles of ADXS-HPV can further improve clinical outcomes and quality of life; Advaxis moving forward with a registration program in recurrent cervical cancer; the collaborative efforts of Advaxis' licensing partners; the initiation or a registration clinical trial program for cervical cancer in 2014; Advaxis' development of ADXS-cHER2 for both human and animal health and its pursuit of a clinical program in pediatric osteosarcoma. These forward-looking statements are subject to a number of risks, including 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, 2013, which is available at http://www.sec.gov. Advaxis 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.
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