VANCOUVER, June 9 /PRNewswire-FirstCall/ - Medifocus, Inc. is pleased to announce that it has been granted the Investigational Testing Authorization (ITA) from Health Canada’s Medical Device Bureau (MDB) for initiating Medifocus’ pivotal trial with the Microfocus APA 1000 Breast Thermotherapy System for the treatment of breast cancer. This ITA application has been reviewed by MDB and has fulfilled Part 3 of the Medical Devices Regulations and is now authorized to conduct the pivotal trial in Canada. ITA is similar to the “No Objection Letter” issued by the Therapeutics Product Directorate for pharmaceutical products.
The Company’s pivotal clinical trial is designed to assess the safety and improvement in efficacy, as measured by increased tumor shrinkage, using its focused microwave heat energy in combination with neo-adjuvant chemotherapy over chemotherapy alone on large breast cancer tumor. The full ITA approval was obtained after the Research Ethics Boards (REB) of the Ville Marie Medical Center and of the St. Mary’s Hospital in Montreal, both granted clearance to begin the pivotal study. Ville Marie is one of the most active comprehensive breast cancer centers in Quebec and the St. Mary’s Hospital is a teaching hospital of the McGill University. Dr. Kyserlingk, the director of Ville Marie Medical Center, will be the principal investigator in Canada for the pivotal study. A total of 238 patients will be entered into the study.
The basis of this ITA-approved pivotal study was from the data analyzed from an FDA allowed phase II multi-center randomized study using the 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% 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 arm.
Dr. Augustine Y. Cheung, Chairman and CEO of Medifocus, Inc., stated; “The Company is excited about this significant milestone achievement in the regulatory process. The approval initiates the final step towards the commercialization of the Company’s APA focused heat treatment system for breast cancer. We believe that the increased efficacy in the shrinkage of large breast tumors will facilitate increased breast conservation surgery which is desired by both the patients and the surgeons. I look forward to completion of the pivotal trial and obtain commercial approval in a timely manner so that we can enter the huge global marketplace for breast cancer treatment. According to the American and Canadian Cancer Societies, over 1.2 million new cases of breast cancer are diagnosed each year. Over 75% of these newly detected breast cancer patients will be scheduled for complete breast removal surgery unless the size of the tumor can be significantly reduced. Our focused heat treatment, once commercialized, may be in a position to help these patients to improve their chance of breast conservation. In the next few months, Medifocus, Inc. will be adding additional study sites in Canada and will begin enrollment of patients for the trial.”
About Medifocus, Inc.
Medifocus owns a patented microwave focusing technology platform (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.
CONTACT: Gilbert Chan, NAI Interactive Ltd, gil@na-investor.com, (604)
488-8878, 1-866-833-5517; John Mon, Medifocus Inc., jmon@medifocusinc.com,
Telephone (410) 290-5734
