Medifocus Inc. has received approval from Health Canada to amend its pivotal Phase III study design and clinical protocol to conform to the study design and clinical protocol as approved by the Food and Drug Administration (FDA) in the USA for the Company’s pivotal Phase III clinical trial on treatment of breast cancer. Medifocus received the full Investigational Testing Authorization (ITA) from Health Canada to initiate the pivotal Phase III trial in Canada in June 2009 and also received the Investigational Device Exemption to initiate the same pivotal trial in the USA from the FDA in March, 2010.
Medifocus’ pivotal Phase III clinical trial design is based on results from four (4) clinical studies performed in the USA with the Company’s Microfocus APA 1000 Breast Cancer Thermotherapy System. The patient data leading to the design of the pivotal trial were summarized and published online on December 22, 2009 in the journal Annals of Surgical Oncology. The article is titled “Focused Microwave Thermotherapy for Preoperative Treatment of Invasive Breast Cancer: A Review of Clinical Studies” by William C. Dooley, MD, Hernan I. Vargas, MD, Alan J. Fenn, PhD, Mary Beth Tomaselli, MD, and Jay K. Harness, MD.
As summarized in the above mentioned review article, the clinical data showed that when the Medifocus focused heat treatment was used in combination with the Standard of Care (SoC) chemotherapy, the median tumor shrinkage in the thermo-chemotherapy 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-chemotherapy 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. The Company’s focused 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.
The pivotal Phase III clinical trial is designed to assess the safety and improvement in efficacy, as measured by increased tumor shrinkage, using the Company’s focused microwave heat energy in combination with neo-adjuvant (pre-operative) chemotherapy over chemotherapy alone on large breast cancer tumors. A total of 238 patients will be entered into the pivotal study at six medical institutions in the USA and Canada as approved by the FDA. Institutional Review Board (IRB) approval will be required at the participating USA medical institutions.
This Health Canada approval allows the Company 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 countries