Medifocus, Inc. (TSXV:MFS) (OTC: MDFZE.PK) a biotechnology company focused on the commercialization of a proprietary and patented microwave focused heat system for the treatment of breast cancer is pleased to announce that the Company had begun trading its common stock on the OTC Pink Sheets market on Dec. 7, 2009.
On June 9, 2009 Medifocus announced that Health Canada had granted full ITA approval to allow the initiation of Medifocus’ pivotal phase III clinical trial on focused heat treatment of breast cancer .In addition, Medifocus has also filed a comprehensive Investigational Device Exemption (IDE) application with the FDA in the United States to obtain clearance to initiate the same pivotal phase III trial using the Company’s Microfocus APA 1000 Focused Heat Thermotherapy System for the treatment of breast cancer in the USA and Worldwide. The pivotal phase III trial is designed to assess safety and efficacy, as measured by increased tumor shrinkage, of using focused microwave heat energy delivered in combination with neo-adjuvant chemotherapy on large breast cancer tumors. A manageable total of 238 patients will be entered into the study. This randomized study will require half (119) to be treated with focused heat treatment plus chemotherapy and the other half (119) with the chemotherapy alone.
The basis of the pivotal study design was provided by the data obtained from an FDA allowed phase II multi-center randomized study using the same Microfocus APA 1000 Thermotherapy System on large breast tumors. The data showed that the median tumor shrinkage in the thermo-chemo arm was 88.4% while for chemotherapy alone, the median tumor shrinkage was only 58.8%. his 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-chemo treatment arm, almost 80% of all breast tumors treated had a tumor volume reduction of 80% or more compared to only 20% for chemotherapy alone. The focused heat treatment provided by the Company’s APA 1000 system, once commercialized, should in a position to help those patients who desire breast conservation by significantly improving their chance of attaining the desired tumor shrinkage to avoid a mastectomy.
Dr. Augustine Y. Cheung, Chairman and CEO of Medifocus, Inc., stated: “We have been working closely with the FDA and believe that the FDA will promptly allow clearance for us to start the same pivotal trial in the USA. Receipt of IDE clearance from the FDA will be a significant strategic milestone for the Company towards our business goal on global commercialization of the Microfocus APA 1000 thermotherapy system for the treatment of breast cancer. It is the Company’s strategy to conduct the USA and Canada studies simultaneously using the same study design. Similarly, we are already listed on the Toronto TSX-V and now with the OTC Pink Sheets, this will allow our companies’ common shares to be duel listed both in the USA and Canada."
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