Medifocus Inc. Reports Improved Clinical Efficacy for its Phase II, Randomized Clinical Study for the Treatment of Large Breast Cancer Tumors
VANCOUVER, April 8 /CNW/ - Medifocus Inc. (TSXV; MFS) announced that positive clinical results, that demonstrate significant efficacy when using the Company's proprietary focused heat treatment in combination with Standard of Care (SOC) preoperative (neo-adjuvant) chemotherapy for large breast cancer tumors, were presented during the Market Opening Ceremony of Medifocus at the Toronto Stock Exchange on March 25, 2009 and also at the 19th National Interdisciplinary Breast Center Conference held March 14-18, 2009 in Las Vegas, Nevada., The patient data were obtained from a multi-center, randomized clinical study to demonstrate improvement in tumor shrinkage when focused heat is used in combination with SOC neo-adjuvant chemotherapy. This study was conducted in the USA under an Investigational Device Exemption (IDE) issued by the Food and Drug Administration (FDA).
The reported clinical trial results demonstrated that when Medifocus's focused heat therapy was added to the SOC neo-adjuvant chemotherapy in the treatment of large breast cancer tumors, tumor shrinkage was increased by an additional 50% over that induced by (SOC) chemotherapy alone. The median tumor shrinkage in the Thermo-chemo arm was 88.4% and for the Chemotherapy alone arm, 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-chemo 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 treatment goal of the Medifocus study is to demonstrate that focused heat treatment combined with SOC chemotherapy performed prior to surgery will significantly lower the need for mastectomy and enhance the chance of successful conversion to breast conserving surgery (BCS), a treatment outcome desired by both the surgeons and breast cancer patients.
Medifocus owns a patented microwave focusing technology (the Adaptive Phased Array ("APA") technology), which can precisely target and control microwave energy to cause heating in cancerous tumors anywhere in the body reliably and repeatedly. 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 and reduced toxicity and to trigger the targeted release of therapeutic drugs and genes at tumor sites at lower temperatures. While the core technology has been licensed from the Massachusetts Institute of Technology, Medifocus has further refined the precision of the microwave focusing and control ability and developed a commercial system dedicated exclusively for the treatment of Breast Cancer. Please visit the company website at www.medifocusinc.com for more info.
Forward Looking Statements and Information
This News Release contains forward-looking statements which may not be based on historical fact. 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 result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments.
%SEDAR: 00023463E -30- /For further information: Jessie Song, NAI Interactive Ltd, (604) 488-8878/1-866-833-5517, firstname.lastname@example.org; John Mon, Medifocus Inc., (410) 290-5734, email@example.com/
Posted: April 2009