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Medifocus Inc. Announces Institutional Review Board Approval for Second USA Site for Its Phase III Pivotal Breast Cancer Treatment Study


Medifocus Inc (OTC: MDFZF) is pleased to announce that the Western Institutional Review Board has granted IRB approval to the Comprehensive Breast Center of Coral Springs Florida, a division of 21st Century Oncology to conduct Medifocus' Pivotal Phase III Breast Cancer Treatment Study, under the supervision of Dr. Mary Beth Tomaselli, M.D.

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 (6) medical institutions in the USA and Canada as approved by the FDA. In addition to the IRB approval for this site, IRB approval was already granted to the University of Oklahoma Breast Institute. With the approval of two USA clinical sites, Medifocus will start the installation and training process of its breast cancer systems there. Thereafter the sites can begin the recruitment and enrollment of patients during the later half of this year.

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. 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. Dr. Tomaselli stated, " I was a co-investigator in the prior Phase II study using the Medifocus Breast Cancer treatment system and have seen first hand excellent tumor shrinkage and control. I am excited to be part of the final Phase III study team and hopefully after completion of the study, it will allow more treatment options to the many women with breast cancer who will benefit by its usage. "The Company's focused heat treatment, once commercialized, may be in a position to help breast cancer patients to improve their chance of receiving breast conservation surgery, thus reducing the need for mastectomy.

Posted-In: News FDA


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