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Standardization of Revolutionary Cancer Treatment Offers Hope to Patients Nationwide

A revolutionary new treatment for patients suffering from abdominal cancer will soon be available to doctors nationwide thanks to a partnership between Wake Forest University School of Medicine and IDT, Inc., a wholly owned subsidiary of Biocontrol Technology of Pittsburgh, Pa (OTC:BB BICO).

New equipment called ThermoChem-HT™ and associated disposables have been developed for use with a therapy called Intraperitoneal Heated Chemotherapy (IPHC). IPHC was developed at Wake Forest University Baptist Medical Center by Dr. Brian Loggie, a surgical oncologist, and his research colleague Ronald Fleming, Pharm D., research assistant professor of internal medicine, hematology and oncology. Loggie is only one of a handful of doctors from around the world specializing in this procedure, which is extending life for many who have few, if any, treatment options left.

Beth Fordham-Meier, director of Technology Transfer and Industry Relations at Wake Forest University, said, "This device will allow us to standardize the procedure and educate others on the utilization of the specialized device, allowing more physicians to provide this life-extending treatment to patients around the world."

Before the procedure, Loggie surgically removes all visible cancerous growths from the patient''s abdomen and pelvis.

"Cancerous growths are removed as completely as possible and all spaces and lining surfaces are opened to enhance exposure for the IPHC procedure," Loggie said. IPHC is then administered as part of the operative procedure.

"The abdomen is perfused with a gently heated physiologic solution containing cancer fighting chemotherapy agents that wash over all the lining surfaces," he said. "This permits direct contact of very high cancer drug concentrations with remaining cancer cells. Heating is used to increase the effectiveness of this interaction."

Five-year data show patients undergoing this treatment live longer and have a better quality of life.

"We are very pleased with the dramatic survival and quality of life benefits that have been observed in our clinical trials initiated in 1991," Loggie said. "IPHC is now offered at our medical center as a standard of care. Ongoing research is a commitment to improvement in patient care and safety. Our goal of the partnership with IDT is to standardize the perfusion delivery system. This will permit wider application of this treatment modality and facilitate further clinical research."

The medical school and IDT also announced they have entered into a research agreement to utilize the ThermoChem-HT equipment and associated disposables in a series of studies designed to evaluate and further improve the method of heated perfusion of chemotherapy drugs. This follows the FDA''s approval to initiate study for advanced gastrointestinal cancer utilizing Loggie''s procedure and the ThermoChem-HT and disposables. The agreement also allows Medical Center physicians to use this equipment in developing similar uses that may lead to additional FDA 510K approvals for other types of cancers.

ThermoChem-HT, a component of the Thermo-Chem System™, used for regional hyperthermia, is being developed under comprehensive standards covering design, manufacturing, installation and servicing systems. IDT plans to submit clinical data to a European Notified Body for consideration of reception of a CE Mark, which signifies that the device meets the requirements for distribution into the European community.

A major research center, Wake Forest University Baptist Medical Center provides the latest treatments to patients and leads the way in researching the new and promising therapies of tomorrow. WFUSM is ranked in the top third of the nation''s medical schools in research funding from the National Institutes of Health.

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Media Contact: Wake Forest University Baptist Medical Center, Rae Beasley at (336) 716-6878 or Jim Steele (336) 716-3487. IDT contacts: Glenn Keeling or Susan Taylor at (412) 279-8715.

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