PRINCETON, N.J., Sept. 26, 2014 (GLOBE NEWSWIRE) -- Advaxis, Inc. (Nasdaq: ADXS ), a biotechnology company developing cancer immunotherapies, announced that ADXS-cHER2, its proprietary Lm -LLO immunotherapy, was featured on Fox News Philadelphia in a segment focused on how dogs battling osteosarcoma (bone cancer) can help lead research for treating osteosarcoma and breast cancer in humans. ADXS-cHER2 is designed to teach the immune system to target the Her2 receptor, which is overexpressed in certain cancers, such as canine and human bone cancer and breast cancer.
The full Fox News segment can be accessed via the following URL: http://www.myfoxphilly.com/clip/10623350/dog-...he-disease .
The Fox broadcast segment, hosted by Karen Hepp, includes an interview with Dr. Nicola Mason, Assistant Professor of Medicine and Pathobiology at the University of Pennsylvania School of Veterinary Medicine. Dr. Mason is the principle investigator on two clinical trials evaluating the safety and efficacy of ADXS-cHER2 in canine osteosarcoma. In the first study, ADXS-cHER2 is being evaluated to determine whether it can prevent the spread of osteosarcoma in dogs that have undergone amputation and chemotherapy (the standard of care for dogs with osteosarcoma). This study is ongoing and the preliminary data is encouraging. The second study evaluates whether ADXS-cHER2 can be combined with radiation therapy to treat the primary tumor as well as prevent spread of the disease into the lungs and prolong overall survival without the need for amputation.
Dr. Mason commented, "ADXS-cHER2 is incredibly exciting and encouraging. We are hoping that this will not only be a cancer immunotherapy to treat dogs and prevent metastatic disease in dogs, but that it will be able to be rapidly translated into the human field, particularly into children that develop the same cancer as dogs do, osteosarcoma."
Daniel J. O'Connor, President and Chief Executive Office of Advaxis, commented, "Dr. Mason's research is promising not only as a potential treatment for pet dogs, but also for children and young adults with osteosarcoma, as well as other Her2-overexpressing cancers such as breast, gastric and esophageal. We look forward to advancing ADXS-cHER2 into the clinic for pediatric osteosarcoma, as well as working alongside our partner, Aratana Therapeutics (Nasdaq: PETX ), to develop and commercialize ADXS-cHER2 for the treatment of osteosarcoma in pet dogs."
As highlighted in the Fox broadcast, most dogs with the disease die within a year of diagnosis, however, some of the dogs treated in Dr. Mason's first clinical study with ADXS-cHER2 are still alive after two years. Preliminary results showed that ADXS-cHER2 was able to delay or prevent metastatic disease and prolong overall survival in dogs with osteosarcoma that had minimal residual disease following the standard treatment of amputation and chemotherapy. As reported by Dr. Mason at The American College of Veterinary Internal Medicine Forum, 80% of the dogs treated (n=15) were still alive and median survival had not yet been reached; median survival in case-matched 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.
About ADXS-cHER2
ADXS-cHER2 is an Lm -LLO immunotherapy for Her2 overexpressing cancers (such as osteosarcoma, breast, gastric and other cancers in humans and for osteosarcoma in canines). ADXS-cHER2 secretes the cHer2 antigen, fused to LLO, directly inside the APC that are capable of driving a cellular immune response to Her2 overexpressing cells. In preclinical analysis, localized effect is the inhibition of the Treg and MDSC cells that we believe may promote immunologic tolerance of the Her2 overexpressing cancer cells of the tumor.
About Canine Osteosarcoma
Osteosarcoma is the most common primary bone tumor in dogs, accounting for roughly 85% of tumors on the canine skeleton. Approximately 8,000-10,000 dogs a year (predominately middle to older-aged dogs and larger breeds) are diagnosed with osteosarcoma in the United States. This cancer initially presents as lameness and oftentimes visible swelling on the leg. Current standard of care treatment is amputation immediately after diagnosis, followed by chemotherapy and sometimes radiation for palliative care. Invariably, however, the cancer metastasizes to the lungs, eventually leading to death.
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 Lm -LLO technology, using bioengineered live attenuated Listeria monocytogenes bacteria, is the only known cancer immunotherapy agent shown in preclinical studies to both generate cancer fighting T-cells directed against a cancer antigen and 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 designation for each of these three indications. The Company plans to initiate a registration clinical program for cervical cancer in 2015 and has established licensing partners in India and Asia for commercialization in those regions. Advaxis is planning to evaluate the combination of ADXS-HPV with an anti-PD-L1 immune checkpoint inhibitor in HPV-associated cervical cancer and head and neck cancer.
Advaxis's second Lm -LLO immunotherapy candidate in clinical testing will be ADXS-PSA, which is being developed to address prostate cancer. Advaxis is planning to file an IND with the FDA and initiate a Phase 1/2 clinical study with ADXS-PSA alone and in combination with a PD-1 checkpoint inhibitor. Advaxis is also developing Lm -LLO immunotherapy ADXS-cHER2, to target the Her2 receptor overexpressing cancers. Her2 is overexpressed in certain solid-tumor cancers, including pediatric bone cancer (or osteosarcoma), breast cancer, esophageal, and gastric cancer. Advaxis is developing ADXS-cHER2 for both human and animal-health, and has seen promising results in canine osteosarcoma, which is considered a model for human osteosarcoma. Advaxis is planning to file an IND for ADXS-cHER2 in Her2 overexpressing cancers and to conduct a clinical program in pediatric osteosarcoma. Advaxis has licensed ADXS-cHER2 and three other immunotherapy constructs to Aratana Therapeutics, Inc.
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Forward-Looking Statements
This news release contains forward-looking statements, including, but not limited to: statements regarding Advaxis's ability to develop the next generation of cancer immunotherapies; the safety and efficacy of Advaxis's proprietary immunotherapy, ADXS HPV; whether Advaxis immunotherapies can redirect the powerful immune response all human beings have to the bacterium to cancers. These forward-looking statements are subject to a number of risks, including the risk factors set forth from time to time in Advaxis's 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.
Advaxis Contact: Lisa Caperelli Senior Director of Investor Relations and Corporate Communications Advaxis, Inc. 215.206.1822 Media Contact: Tiberend Strategic Advisors, Inc. Amy S. Wheeler 646.362.5750
