Medifocus Inc. (OTC:MDFZF.PK and TSXV:MFS) is pleased to announce that its breast cancer treatment technology is the feature article in the Missile Defense Agency's (MDA) TechUpdate. The full article can be seen here.
In the MDA cover story article, "A New Target for Radar Technology", the technology behind the design of the Medifocus APA-1000 breast cancer treatment system is described. The article documents the technology transfer and collaborative research efforts between Dr. Alan J. Fenn, inventor of the APA technology at the Massachusetts Institute of Technology (MIT) and engineers at Medifocus, leading to the successful development of the Company's tumor-targeted focused heat treatment system for breast cancer.
The adaptive phased array (APA) radar technique was developed at MIT by Dr.Fenn as part of the Strategic Defense Initiative. The APA technology was originally developed to detect and track incoming airborne cruise missiles. With technology transfer support from MIT, Medifocus successfully developed the APA 1000 focused heat cancer treatment system. Besides breast cancer, Medifocus is also planning to use the APA technology to develop treatment systems for other cancers.
In March 2010, Medifocus announced that it had received from the Food and Drug Administration (FDA) an Investigational Device Exemption (IDE) approval to initiate a pivotal Phase III clinical trial using the APA -1000 system for treatment of breast cancer. Medifocus has also been granted a full Investigational Testing Authorization (ITA) approval to initiate the same pivotal Phase III study in Canada .
Medifocus' pivotal Phase III clinical trial design is based on results from four (4) clinical studies performed at ten medical institutions in the USA. The patient data leading to the design of the pivotal trial were summarized and published online December 22, 2009 in the journal Annals of Surgical Oncology by William C. Dooley, MD, et al. As summarized in the review article, the clinical data showed that when the Medifocus focused heat treatment was added to Standard of Care (SoC) chemotherapy, the median tumor shrinkage in the thermo-chemotherapy arm was 88.4% while for chemotherapy alone, the median tumor shrinkage was only 58.8%. This increase in median tumor shrinkage was statistically significant with a P value equal to 0.048. In addition, the data indicated that for the thermo-chemotherapy treatment arm, almost 80% of all breast tumors treated had a tumor volume reduction of 80% or more compared to only 20% for the chemotherapy alone. The Company's focused heat treatment, once commercialized, may be in a position to help these patients to improve their chance of breast conservation thus reducing the need for mastectomy.
The pivotal Phase III clinical trial is designed to assess the safety and improvement in efficacy, as measured by increased tumor shrinkage, using the Company's focused microwave heat energy in combination with neo-adjuvant (pre-operative) chemotherapy over chemotherapy alone on large breast cancer tumors. A total of 238 patients will be entered into the pivotal study at six medical institutions in the USA and Canada as approved by the FDA. Institutional Review Board (IRB) approval will be required at the participating USA and Canadian medical institutions.
Source:
Medifocus, Inc.
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