Medifocus, Inc. Announces Positive Clinical Results Of Its Breast Cancer Treatment Studies Published In Annals Of Surgical Oncology

Medifocus, Inc. (OTC:MDFZF.PK and TSXV:MFS) is pleased to announce that a review article summarizing clinical studies of the Company's Microfocus APA 1000 Breast Cancer Thermotherapy System was published online December 22, 2009 in the journal Annals of Surgical Oncology. The article "Focused Microwave Thermotherapy for Preoperative Treatment of Invasive Breast Cancer: A Review of Clinical Studies" by William C. Dooley, MD, et al, provides a review of positive results that have been obtained from Phase I safety data, Phase II dose escalation data and randomized Phase II efficacy data that have been gathered with the Company's APA 1000 Thermotherapy system.


In the review article, the data in one of the randomized trials for patients with large breast cancer tumors showed that with focused microwave thermotherapy treatment the median tumor shrinkage in the new combined Microfocus APA 1000 thermotherapy-chemotherapy arm was 88.4% while for preoperative 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 also indicated that for the thermo-chemotherapy treatment arm, almost 80% of all breast tumors treated had a tumor volume reduction of 80% or more as compared to only 20% for the tumors treated by chemotherapy alone. The Company believes that the focused microwave heat treatment, once commercialized, may be in a position to help these patients to improve their chance of breast conservation; thus reducing the need for mastectomy. In addition, the review article also summarized the clinical results from another FDA allowed phase II multi-center randomized study using the Microfocus APA 1000 Thermotherapy System for patients with early-stage breast cancer. The data showed that patients receiving the focused microwave thermotherapy treatment prior to surgery had 0% positive tumor margins compared to 9.8% positive tumor margins for patient receiving surgery alone. As indicated in the review article, reducing the risk of positive tumor margins is important in reducing the recurrence of breast cancer. Even though a larger randomized study is required to establish the clinical potential of the system's ability to reduce the risk of positive tumor margins, the Company believes the results should further enhance the acceptance of using thermo-chemotherapy for tumor eradication and/or shrinkage by both the surgeons and the patients


The reviewed data provided the basis of the design of a randomized phase III pivotal trial for Medifocus to assess the improvement in efficacy, as measured by increased tumor shrinkage, of using the Company's focused microwave heat energy delivered by the Microfocus APA 1000 system in combination with neo-adjuvant (preoperative) chemotherapy on large breast cancer tumors over chemotherapy alone. A total of 238 patients will be entered into the randomized study.















On June 9, 2009, Medifocus announced that Health Canada had granted full Investigational Testing Authorization (ITA) to the Company to conduct a pivotal Phase IIII trial for patients with large breast cancer tumors in Canada. Medifocus is working with Ville Marie Medical Center in Montreal, Quebec as the first clinical site which has received ethics board approval, to schedule to have the APA 1000 system installed, and then begin recruitment and enrollment of patients to start the pivotal trial. Medifocus has also filed an Investigational Device Exemption (IDE) application with the FDA in the United States to obtain clearance to initiate the same pivotal Phase III trial in the USA and worldwide. The Company is diligently corresponding with the FDA and working closely with the FDA to answer questions and obtain the necessary approval. The Company is expecting to receive approval from the FDA to begin the pivotal study in early 2010.


Dr. Augustine Y. Cheung, Chairman and CEO of Medifocus, Inc., stated: "The receipt of the full authorization from Health Canada to begin the pivotal phase III trial is a significant first step in establishing Medifocus as a mature biotechnology company with an oncology medical system at an advanced stage of clinical development. The Company also believes that the FDA will also grant clearance for Medifocus to start the same pivotal phase III studies in the USA in early 2010. Obtaining the IDE clearance to start the Pivotal trial from the FDA will be the significant strategic milestone for the Company towards global commercialization of the Company's focused heat thermotherapy system for the 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 the USA and Canada can be shared and used towards obtaining commercial approval for the system initially in North America followed by the other parts of the world."


Dr. Cheung further stated: "Medifocus purchased the Adaptive Phased Array (APA) Focused Heat Technology Platform from Celsion Corporation (NASDAQ: CLSN) in January 2006 for commercial development. I truly believe in the clinical potential of using focused heat in cancer treatment. With a seasoned management team, an experienced product development team, and support from Dr. Alan J. Fenn, the inventor of the APA breast thermotherapy technology, and also the continuous support of the Technology Licensing Office of the Massachusetts Institute of Technology (MIT), the Company advanced the Microfocus APA 1000 Thermotherapy System for Treatment of Breast Cancer to the final Pivotal Phase III stage of commercial development. Medifocus' strategy is to focus on the commercialization of the breast cancer treatment system to provide a " Kinder and Gentler" treatment to the over 1.2 million new breast cancer patients worldwide. The success of the breast cancer treatment system will validate the APA technology and its clinical potential to develop other systems to treat other cancers effectively on a minimally invasive basis, either alone or in combination with other conventional treatment modalities. It will also help Medifocus to attract additional fundings and collaborations from strategic partners." In developing the clinical focused heat thermotherapy system for breast cancer, I have used the same proven management approach that I used at Celsion Corporation in successfully developing a clinical benign prostatic hyperplasia (BPH) thermotherapy treatment technology (Prolieve(R) Thermodilation System) that was eventually sold in June 2009 to Boston Scientific Corporation (NYSE: BSX).


Source

Medifocus, Inc.