Clinical Trial Seeks Patients in Southern California; St. Joseph Hospital Leads Microwave Thermotherapy Clinical Trial for Breast Cancer Patients.

Health/Medical Writers

ORANGE, Calif.--(BUSINESS WIRE)--Jan. 12, 2004

St. Joseph Hospital of Orange, a 448-bed, not-for-profit Catholic hospital serving Orange County, Calif., is seeking patients to participate in two clinical trials -- carefully controlled research studies with actual patients -- currently underway for Microwave Thermotherapy, an emerging technology offered for early stage and advanced breast cancer. Women over age 18 with all stages of breast cancer are encouraged to participate.

Microwave Thermotherapy was developed by the Massachusetts Institute of Technology, which licensed its use exclusively to the Celsion Corporation. St. Joseph Hospital is one of just 15 medical centers nationwide selected to participate in the clinical trials.

Breast cancer is the most common form of cancer in women, with approximately 200,000 new cases diagnosed in the United States each year. With most breast cancer cases, the entire breast is at risk and must be treated to ensure that all cancer cells are destroyed. Despite extensive use of surgery, chemotherapy and radiation therapy, current breast cancer treatments cannot always completely destroy all cancer cells in the breast. Microwave Thermotherapy is being studied as an alternative, more effective treatment option.

"Microwave Thermotherapy provides an innovative, minimally invasive approach to the pre-operative treatment of breast cancer using a targeted microwave device called the Microfocus APA1000 System," said Jay K. Harness, M.D., medical director, St. Joseph Hospital Comprehensive Breast Center. "The system applies direct heat to the tumor, killing cancer cells located within the mass as well as the surrounding vicinity. Once the cancer cells are killed, the tumor shrinks in size and becomes more easily treatable.

"In advanced stages of breast cancer, surgery following Microwave Thermotherapy treatment can be reduced from a mastectomy to a partial mastectomy, while in early stages, no follow-up surgery may be needed," Harness continued. "This procedure is non-surgical and preserves fatty tissues, thus avoiding damage to the breast and helping it remain intact. Another great benefit is that patients receive a local anesthetic and experience no toxic side effects following the treatment."

Two Clinical Trials Available at St. Joseph Hospital

Celsion has successfully completed pilot and phase II clinical trials for Microwave Thermotherapy and currently is conducting two FDA-approved pivotal clinical trials at St. Joseph Hospital on its Microfocus APA1000 System. These include:

-- Pivotal Study 102-00-201: This clinical trial is designed to

demonstrate that the Microfocus APA1000 System, when used in

conjunction with pre-operative chemotherapy in advanced cases

(stage 3 cases) of breast cancer, can kill cancerous cells

located in the tumor and surrounding vicinity. The shrinking

of the tumor may enable the patient to be treated using a

partial mastectomy or lumpectomy procedure, as opposed to a

full mastectomy.

-- Pivotal Study 102-00-202: This clinical trial involves the use

of the Microfocus APA1000 system to treat early stage breast

tumors prior to lumpectomy and radiation. This protocol has

been designed to destroy the tumor and reduce the need for

further breast surgery -- also known as re-excision.

How Microwave Thermotherapy Works

The Microfocus APA1000 System applies focused microwaves externally using large opposing applicators surrounding the compressed breast. The applicators bathe a large region of the breast in focused microwave energy, while protecting the skin and surrounding tissue. The focused microwave energy targets breast cancer cells with high water content. During the treatment, which requires 60 minutes or less, one minimally invasive needle sensor monitors the breast. The goal of this treatment is to destroy the primary breast tumor and any microscopic cancer cells that may exist in the tumor margins and throughout the breast. In initial clinical trials, the technology produced significant tumor response (tumor shrinkage and/or tumor kill) in 80 percent of breast cancer cases.

"When I joined the staff at St. Joseph Hospital earlier this year, one of my missions was to uncover and incorporate emerging technologies in the field of breast care -- this technology fits the bill," said Harness. "The results we've seen so far are encouraging, but we need additional patients to participate in order to maintain the discovery of information and help produce scientific advances that aid in the prevention, diagnosis and treatment far beyond what is available right now. It is clinical trials like these that can give the medical community the data it needs to shape and define the treatment methods used to help fight diseases such as breast cancer."

For more information regarding the Microwave Thermotherapy clinical trials taking place at St. Joseph Hospital, or to inquire about whether you qualify to participate, please call 714-744-8601. For more information about the healthcare services offered at St. Joseph Hospital, or to locate a physician by specialty, visit the hospital's Web site at www.sjo.org.

About St. Joseph Hospital's Comprehensive Breast Center

The St. Joseph Hospital Comprehensive Breast Center is dedicated to being a regional resource center where breast health services are offered to meet the diverse needs of patients along the continuum of care. Programs and services are centered on care provided in a holistic environment; care that promotes and fosters a collaborative and interdisciplinary team approach with the patient at the center of all breast health services coordination. St. Joseph Hospital's Breast Imaging Center was recently awarded a three-year term of accreditation from the American College of Radiology's Breast Ultrasound Accreditation Program for breast ultrasound, core-needle biopsy and fine-needle aspiration cytology, and received a perfect score of 100 following the evaluation process.

About St. Joseph Hospital

Since 1929, St. Joseph Hospital, a 448-bed, not-for-profit Catholic hospital has been dedicated to extending the healthcare ministry of the Sisters of St. Joseph of Orange. With a reputation for delivering compassionate care, clinical excellence and superior outcomes, St. Joseph Hospital prides itself on providing this care in an atmosphere that treats the whole person -- body, mind and spirit. Dignity, Service, Excellence and Justice are more than words to the hospital's 1,000-member medical staff, as many -- physicians, nurses and hospital employees -- donate their time in serving Orange County's medically underserved. St. Joseph Hospital has earned the distinction of "most preferred hospital" in Orange County and offers many outreach services, a freestanding medical and dental clinic, mobile community clinics and a holistic care center. For additional information, call St. Joseph Hospital at 714-744-8075 or visit www.sjo.org.