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Aethlon Medical, Inc. (OTCBB:AEMD), the pioneer in developing therapeutic filtration devices to address infectious disease and cancer, announced this week , the introduction of HER2osome™, a novel medical device strategy to inhibit the progression of HER2+ breast cancer, which is characterized by aggressive growth and poor prognosis resulting from the over-expression of HER2 protein. Breast cancer represents the most common form of invasive cancer in women. HER2+ breast cancer accounts for approximately 25% of new breast cancer diagnosis.
A white paper entitled: "A Medical Device Strategy to Inhibit HER2+ Breast Cancer Progression can be accessed online at: www.slideshare.net/Aethlon/a-medical-device-to-inhibit-her2-breast-cancer
The goal of HER2osome™ therapy is to simultaneously reduce the circulatory presence of HER2 protein and breast cancer exosomes, which have increasingly become recognized as playing pivotal role in the development and progression of breast cancer. Researchers report that breast cancer exosomes suppress the immune response, stimulate angiogenesis, contribute to the spread of metastasis, and inhibit the therapeutic benefit of Herceptin (trastuzumab), a leading monoclonal antibody treatment against the HER2+ breast cancer. As an adjunct therapeutic candidate, HER2osome™ offers to address an unmet medical need and enhance the benefit of Herceptin and standard of care chemotherapies without adding drug toxicity or interaction risks.
On September 24 th, ImmunoGen, Inc. (Nasdaq:IMGN ), a biotechnology company that develops targeted anticancer products using its TAP technology, reported findings from the first randomized clinical trial conducted with trastuzumab emtansine (also known as T-DM1). Trastuzumab emtansine consists of ImmunoGen's DM1 cancer cell-killing agent attached to the HER2-targeting antibody, trastuzumab, developed by Genentech, a member of the Roche Group, and is in global development by Roche. The study findings are being presented (abstract #5001; presentation at 9:10 am CET on Sept. 25) at the 2011 European Multidisciplinary Cancer Congress taking place in Stockholm, Sweden.
The results are from a 137-patient, randomized Phase II trial conducted by Roche comparing trastuzumab emtansine, used as a single agent, against Herceptin(R) (trastuzumab) plus chemotherapy (docetaxel) for first-line treatment of HER2-positive metastatic breast cancer. Herceptin plus chemotherapy is standard of care for this cancer. The primary endpoints of the study were progression-free survival (PFS) and assessment of safety.
The Company noted, "It is noteworthy that single-agent therapy with trastuzumab emtansine demonstrated both efficacy and tolerability advantages over Herceptin given with separate chemotherapy," commented Daniel Junius, President and CEO. "These findings further demonstrate the power of our TAP technology. We expect the body of impressive clinical results to grow substantially as the number of later-stage trials underway with TAP compounds continues to increase."
Trastuzumab emtansine is in Phase III testing for first-, second-, and third-line treatment of HER2-positive metastatic breast cancer (the MARIANNE, EMILIA, and TH3RESA trials, respectively) and in Phase II testing for adjuvant/neoadjuvant use for earlier-stage disease. Roche expects to report results from the second-line, EMILIA trial in 2012 and to use these results to support a global regulatory submission for trastuzumab emtansine in 2012. Three other compounds utilizing ImmunoGen's TAP technology -- IMGN901, SAR3419, and BT-062 -- are expected to be in Phase II clinical testing by mid-2012, with as many as seven other TAP compounds in early stage clinical testing.
About Aethlon Medical
The Aethlon Medical mission is to create innovative medical devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions. Aethlon's ADAPT™ platform provides the technology foundation for a new class of therapeutics that target the selective removal of disease enabling particles from the entire circulatory system. The Aethlon ADAPT™ product pipeline includes the Hemopurifier®, a first-in-class medical device with broad-spectrum capabilities against exosomes that contribute to the progression of cancer and infectious viral pathogens such as HIV and Hepatitis C. For more information, please visit www.aethlonmedical.com.]
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