VANCOUVER--(BUSINESS WIRE)--Medifocus, Inc. (TSXV:MFS) is pleased to announce that it has filed an IDE application with the FDA in the United States to obtain clearance to initiate a pivotal phase III clinical trial using the Company’s Microfocus APA 1000 System for the treatment of breast cancer in the US and worldwide.
The pivotal clinical trial is designed to assess the safety and improvement in efficacy, as measured by increased tumor shrinkage, of using focused microwave heat energy delivered by the Microfocus APA 1000 system in combination with neo-adjuvant chemotherapy on large breast cancer tumors. A total of 238 patients will be entered into the study.
The basis of this pivotal study was provided by 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% 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-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.
Medifocus announced on June 9, 2009 that Health Canada had granted full ITA approval to allow the initiation of the same pivotal studies in Canada and commercialization of the system. Medifocus is actively working with Ville Marie Medical Center in Montreal to begin their recruitment and enrolling of patients to start the pivotal trial.
Dr. Augustine Y. Cheung, Chairman and CEO of Medifocus, Inc., stated:
The filing of the IDE with the FDA and eventually receiving clearance from FDA to start the pivotal studies in the USA are significant strategic milestones for the Company towards global commercialization of the Microfocus APA 1000 thermotherapy system for treatment of breast cancer. It is the Company’s strategy to conduct the USA and Canada studies simultaneously using the same study design and clinical protocol so that patient data obtained from both USA and Canada can be shared and used towards obtaining commercial approval for the system from both Canada and the USA. I believe that the ability to obtain commercial approval for our breast cancer treatment system from two well regarded regulatory agencies worldwide should significantly enhance our ability to rapidly gain acceptance for the product globally and facilitate in our effort to line up strategic distribution partners from every part of the world.
I am very excited about this significant milestone achievement in the regulatory process. 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.
About Medifocus, Inc.
Medifocus owns a patented microwave focusing technology platform the Adaptive Phased Array ("APA") system, 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. While the core technology has been licensed from the Massachusetts Institute of Technology (MIT), Medifocus has completed the development of a dedicated commercial cancer treatment system for the treatment of breast cancer. Please visit www.medifocusinc.com for more details.
Contact:
NAI Interactive Ltd Gilbert Chan, 604-488-8878 1-866-833-5517 gil@na-investor.com or Medifocus Inc. John Mon, 410-290-5734 jmon@medifocusinc.com
