COLUMBIA, Md.--()--Medifocus Inc. (OTC:MDFZF.PK and TSXV:MFS) is pleased to announce that the University of Oklahoma Health Sciences Center’s Institutional Review Board (IRB) has granted final approval to conduct Medifocus’ Pivotal Phase III Breast Cancer Treatment Study at the University of Oklahoma Breast Institute, in Oklahoma City, under the supervision of William C. Dooley, M.D. the Principal Investigator for the Food and Drug Administration (FDA) approved study.
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. With the IRB approval, the Oklahoma site can begin the process of recruitment and enrollment of patients by early 2011. The Company expects that IRB approvals for the other five sites to shortly follow and to fully initiate the trial at all sites by mid 2011 or earlier.
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 breast cancer patients to improve their chance of receiving breast conservation surgery, thus reducing the need for mastectomy.
About Medifocus, Inc.
Medifocus owns a patented APA microwave focusing technology platform which can precisely target and concentrate microwave energy to destroy cancer tumors without damaging healthy tissue when used alone or in conjunction with chemotherapy or radiation. The ability to target tumors with a precision controlled dose of heat can be used to destroy tumors at higher temperatures, to treat tumors in combination with chemotherapy and/or radiation at moderate temperatures for increased effectiveness over those treatments alone, and to activate temperature sensitive drugs for tumor targeted localized drug delivery. Medifocus has completed the development of a dedicated commercial cancer treatment system for the treatment of breast cancer and is actively pursuing development of additional systems for other cancers.
Forward-Looking Statements and Information:
This news release contains forward-looking statements, which may not be based on historical facts. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. These factors should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements. The Company disclaims any obligation to update any such factors or to publicly announce the results of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments.