In 1983 the U.S. initiated the Star Wars program (Strategic Defense Initiative) – one which would have satellites isolate and destroy enemy missiles headed toward the nation's borders. Although the program was highly criticized, called unrealistic and bore little fruit, a company is using technology from the program to treat women suffering from breast cancer.

Medifocus (Vancouver, British Columbia) reported that it has received an IDE approval to initiate a pivotal Phase III clinical trial for its Microfocus APA 1000 System.

"Basically we have been developing this technology in conjunction with the Massachusetts Institute of Technology (MIT; Cambridge, Massachusetts)," John Mon, COO of Medifocus told Medical Device Daily.

But Mon pointed out the device has its roots in the now defunct Star Wars program and operates under the same premise. But instead of attacking missiles the device focuses on attacking tumors.

The company had already reported that Health Canada had granted it full investigational testing authorization approval to allow the initiation of the same pivotal phase III study in Canada.

"We would like to run both studies at the same time," Mon said. "We hope to have 238 patients in these phase III studies."

According to the company, the study is to be held at six sites.

Medifocus' pivotal phase III clinical trial design is based on results from four clinical studies performed in the U.S. 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 Dec. 22, 2009 in the journal Annals of Surgical Oncology in an article titled "Focused Microwave Thermotherapy for Preoperative Treatment of Invasive Breast Cancer: A Review of Clinical Studies."

The clinical data showed that when the Medifocus focused heat treatment was added to 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%.

The company said that 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.

"This current clinical trial is really based on the phase II data that we gathered. We are able to improve tumor shrinkage by 40% above what chemo [therapy] could do alone," Mon said. "We're trying to make chemo work a bit better with this technology. By itself, chemotherapy is only about 30% effective."

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.

"We estimate, based on our past studies, that we will be able to make an application for [commercialization] in about 30 months," Mon told MDD.

Plans also call for the company to eventually look toward commercialization in Europe. But Mon said the focus was first going to be in the U.S. and Canada.

If the product comes to market, then it could be a huge breakthrough in treating breast cancer and could quite possibly give the patients a much stronger form of therapy the company noted.

"I think this is a win-win situation for the patients and the surgeon," Mon said. "I think the surgeon would love the treatments on breast cancer to be more effective and I think that women who have large tumors in their breasts would want to salvage their breasts if possible."

Omar Ford, 404-262-5546;
omar.ford@ahcmedia.com