Medifocus Inc. Reports Improved Clinical Efficacy for its Phase II, Randomized Clinical Study for the Treatment of Early Stage Breast Cancer Tumors
VANCOUVER, April 15 /PRNewswire-FirstCall/ -- Medifocus Inc. (TSXV:MFS) announced that positive clinical results when using the Company's proprietary focused heat treatment prior to surgery for the treatment of early stage 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 reduce cancer cells at the surgical margins, which potentially can reduce either re-excisions rates or second incision rates when Medifocus's focused heat, is delivered prior to surgery. This study was conducted in the USA under an Investigational Device Exemption (IDE) issued by the Food and Drug Administration (FDA). The data presented at the 2009 National Interdisciplinary Breast Center Conference represent the final analysis of the clinical data for the focused heat treatment for early-stage breast cancer. Dr. William C. Dooley, MD, at the University of Oklahoma, Health Sciences Center, was the Principal Investigator of the multi-institutional study that was conducted at 10 breast centers in the United States and the United Kingdom.
The primary treatment modality for the treatment of early stage breast cancer is surgery. For early stage breast cancer, if the tumor is detected early enough, and the tumor is small enough, then a breast conservation surgery (BCS) known as lumpectomy could be offered. One of the biggest concerns for lumpectomy is positive tumor margins, which normally will require either re-excision or second incision to remove the remaining cancer cells. In addition, clinical studies indicate that if the surgery is performed and the margin is positive with cancer cells, then there is an estimated 500% increase in the chance for recurrence of the breast cancer compared to when the margins are negative. The reported clinical trial results demonstrated that when Medifocus's focused heat therapy alone was delivered prior to surgery, 0 of 34 (0%) of the tumors removed had positive margins whereas in the surgical arm without receiving the focused heat treatment, 4 of 41 or almost 10% had positive margins.
This study, along with the positive clinical efficacy results of another randomized study for the treatment of large breast cancer tumors that Medifocus reported last week, demonstrates that Medifocus's focused heat technology can potentially treat the majority of all localized and invasive breast cancer tumors detected. The study reported last week, demonstrated that when the Medifocus's focused heat was added to the standard of care (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 treatment goal of the Medifocus study on early stage breast cancer, is to demonstrate that focused heat treatment delivered prior to surgery can improve surgical outcomes and decrease the need for re-excisions or a second incision which can improve cosmesis and may reduce recurrent rates of the breast cancer.
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 www.medifocusinc.com for more details.
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.
Source: Medifocus Inc.
Posted: April 2009