PRINCETON, N.J., June 30, 2014 (GLOBE NEWSWIRE) -- Advaxis, Inc. (Nasdaq: ADXS ), a biotechnology company developing cancer immunotherapies, announced that ADXS-cHER2, its proprietary immunotherapy, was featured on CBS New York in a segment focused on encouraging data from a second study combining ADXS-cHER2 with radiation therapy to treat companion dogs with osteosarcoma (bone cancer). The reporters commented that treatment prolongs the lives of dogs with bone cancer and could one day help people with cancer. ADXS-cHER2 targets the Her2 receptor, which is overexpressed in certain solid-tumor cancers, including canine and human bone cancer and breast cancer. Advaxis intends to initiate a clinical development program with ADXS-cHER2 in pediatric osteosarcoma, based on previously reported canine data.
The full CBS segment can be accessed via the following URL: http://newyork.cbslocal.com/video/10303514-dr...ne-cancer/
The CBS broadcast segment, hosted by Dr. Max Gomez, includes an interview with Dr. Nicola Mason, Assistant Professor of Medicine and Pathobiology at the University of Pennsylvania School of Veterinary Medicine, who is the principle investigator of a second clinical trial designed to evaluate whether treatment with ADXS-cHER2, combined with radiation therapy, can decrease bone cancer pain and prolong overall survival in companion dogs, without the need of amputation.
Dr. Mason commented, "In the past we have tested ADXS-cHER2 to determine whether it can prevent spread of osteosarcoma in dogs that had undergone amputation and chemotherapy (the standard of care for dogs with osteosarcoma). The results were encouraging. Now we are evaluating whether ADXS-cHER2 can be used to treat the primary tumor as well as prevent spread of the disease into the lungs – that is, we are now treating dogs that cannot undergo amputation and follow up chemotherapy."
Featured alongside Dr. Mason was the first dog to be enrolled in the current clinical trial, Denali, a 10-year-old therapy dog at the New York Methodist Hospital. Denali has been treated with ADXS-cHER2 every three weeks since January after suffering a fracture of his right front humerus due to an osteosarcoma tumor. As of today, Denali's fracture has healed and his cancer has not spread to his lungs or lymphatic system. In addition to returning to work as a therapy dog, he is able to walk 16 blocks a day and run on the beach.
Daniel J. O'Connor, President and Chief Executive Office of Advaxis, commented, "Dr. Mason's research is not only promising as a potential treatment for companion dogs with osteosarcoma, but also for human patients with osteosarcoma and other Her2-overexpressing cancers such as breast, gastric and esophageal. We look forward to advancing ADXS-cHER2 into the clinic for Her2-overexpressing cancers, as well as working alongside our partner, Aratana Therapeutics (Nasdaq: PETX ), to develop and commercialize ADXS-cHER2 for the treatment of osteosarcoma in dogs."
As highlighted in the CBS broadcast, most dogs with the disease die within a year of diagnosis, however, many 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 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 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 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, which is considered 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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Forward-Looking Statements
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 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' 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
