Medifocus Announces the Initiation of Its Principal Investigational Site in Canada for Its Pivotal Phase III Clinical Trial for Breast Cancer Treatment
Published: Aug 09, 2013
COLUMBIA, MD and TORONTO--(Marketwired - August 09, 2013) -
John R. Keyserlingk, MD, MSC, FRCS©, FACS, Surgical Oncologist and Director of the VM Breast and Oncology Centers stated, "I and my multi-disciplinary team involved with breast cancer management are very pleased to be part of this Phase III pivotal study for the treatment of Locally Advanced Breast Cancer. Combining pre-operative microwave thermotherapy to the involved breast, alongside our best chemotherapy, has the potential to significantly reduce the tumour burden beyond what can be provided by chemotherapy alone. When all, or nearly all, the tumour cells have been eliminated by the time the patient undergoes surgery, she then benefits from both best survival prognosis, and a reduced need for total mastectomy, the latter usually required for patients with large breast tumors. Upon successful completion of the study, and if approved, this technology will offer our patients, and many other breast cancer patients, additional and greatly needed treatment options, including potentially reducing the size of the surgical interventions."
The Pivotal Phase III Breast Cancer treatment study has been approved to be initiated by both the USA Food and Drug Administration and the Canadian Bureau of Medical Devices (BMD). The USA Principal Investigational site has already been initiated at the University of Oklahoma Breast Institute under the supervision of the Company's US Principal Investigator, Dr. William C. Dooley, MD. The goal of the 238 patient Medifocus-sponsored randomized Phase III study is to demonstrate that preoperative focused microwave heat treatment and chemotherapy combined are more effective than preoperative chemotherapy alone in the treatment of large breast cancer tumors in the intact breast. Combining heat with chemotherapy before surgery can potentially shrink the tumor so that it can be removed in a breast conserving surgery (lumpectomy), thus reducing the need of a mastectomy.
Dr. Augustine Y. Cheung, President and CEO stated, "We are very pleased to have initiated this site in Canada for the Medifocus Breast Cancer Treatment System in our Pivotal Phase III study. This event is another major milestone for Medifocus towards the commercialization of our breast cancer treatment system in the United States, Canada and worldwide."
Further details of the Medifocus Pivotal Phase III study are published on the www.clinicaltrials.gov web site.
About Medifocus, Inc.
Medifocus owns two fully developed technology platforms with comprehensive US and international patent protection: (1) The Endo-thermotherapy Platform-a catheter-basis focused heat technology platform that utilizes natural body openings to deliver precise microwave thermotherapy to the diseased sites. The U.S. FDA approved Prolieve Thermodilatation System for the treatment of Benign Prostatic Hyperplasia ("BPH") was developed based on the Endo-thermotherapy and is currently generating revenue, and (2) The Adaptive Phased Array (APA) Microwave Focusing Platform-invented by MIT, licensed to Medifocus, directs precisely focused microwave energy at tumor center to induce shrinkage or eradication of tumors without undue harm to surrounding tissue. The Company's APA 1000 Breast Cancer Treatment System, developed from the APA technology platform has received approval from the U.S. FDA and Health Canada to conduct the pivotal Phase III clinical trials. The Company believes that these two technology platforms can provide the design basis for the development of multiple cancer treatment systems for surface, subsurface and deep seated localized and regional cancers. Please visit www.medifocusinc.com, www.prolieve.com and http://www.facebook.com/pages/Medifocus-Inc-Company-Page/546315028715627 for more details.
About VM Medical Multidisciplinary Breast Center
Since its founding in 1994 VM Medical has established itself as a leader in breast cancer diagnosis and care. The VM Medical Multidisciplinary Breast Center's three units -- the VM Medical Rapid Diagnostic Breast Center, the VM Medical Oncology Center and the VM Medical Integrative Health & Wellness Center -- make up what is today the largest private breast center in Canada. With on-site direct digital (DR) mammography, MRI, PET-CT, nuclear medicine, and our rapid pathology service, patients benefit from both rapid diagnosis and rapid treatment. Last year alone our multidisciplinary team of physicians diagnosed and treated over 450 new cases of breast cancer. The VM Medical breast center is accredited by the Canadian Association of Radiologist, the American College of Radiology and is an accredited member of the National Consortium of Breast Centers.
Forward-Looking Statements and Information
This news release contains "forward-looking statements" and "forward-looking information," which may not be based on historical facts. Forward-looking statements and forward-looking information, include, but are not limited to, information and statements with respect to the benefit to Medifocus's future growth resulting from the acquisition of additional intellectual property rights, additional treatment possibilities and the expectation that sales from Prolieve® may accelerate as a consequence. Forward-looking statements are frequently characterized by words such as "plan," "expect," "project," "intend," "believe," "anticipate," "estimate" and other similar words, or statements that certain events or conditions "may" or "will" occur. Forward-looking statements are based on the opinions and estimates of management at the date the statements are made. Such forward-looking statements and forward-looking information involve known and unknown risks, uncertainties and other factors that may cause the actual results events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements or forward-looking information. These factors should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements and forward-looking information. Except as required by applicable securities laws, the Company disclaims any obligation to update any such factors or to publicly announce the results of any revisions to any of the forward-looking statements or forward-looking information contained herein to reflect future results, events or developments.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
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