Medical Device Daily

After three years of successfully treating prostate cancer patients with its brachytherapy seeds, IsoRay Medical (Boston) last week reported this targeted cancer therapy used in three patients suffering from a form of eye cancer, intraocular melanoma.

"IsoRay Medical has been treating prostate brachytherapy patients since the first patient was treated at the University of Washington [Seattle] in October 2004 using brachytherapy seeds with the isotope Cesium-131," Lori Woods, VP of IsoRay told Medical Device Daily. "Prior to that we received 510(k) clearance to treat malignant disease in soft tissue basically from head to toe." She said that the company's initial focus was then on using its brachytherapy technology for prostate cancer "based on the size of the market."

In addition to prostate cancer, brachytherapy has been used to treat cancers of the cervix, head and neck, ovary, breast, gallbladder, uterus and vagina, according to the American College of Radiology (Reston, Virginia).

The brachytherapy implants were performed last at Tufts-New England Medical Center (Boston), with help from Mark Rivard, PhD, associate professor of radiation oncology at Tufts University School of Medicine and chief medical physicist at Tufts-New England Medical Center.

"Cesium-131's unique characteristics, including minimizing healthy tissue dose, which is a benefit for the patient, may offer significant clinical advantages," said Rivard, serving also as an IsoRay consultant.

IsoRay received FDA clearance to market its Cesium-131 seeds in March 2003. During the procedures, Cesium-131 brachytherapy seeds — encased in a small disc-shaped shield (plaque) with a protective gold backing — were attached to the surface of the patients' eyes over the area to be treated. The plaques were then removed a day or two later.

Cesium-131 is marketed under the brand Proxcelan. It has been used in more than 2,000 prostate cancer brachytherapy procedures since October 2004, Woods told MDD, adding that, "Our seeds are also used in conjunction with intensity modulation radiation therapy, external beam radiation therapy to treat late stage or high risk patients.

"Based on the radiobiology characteristics of our isotope, we believe we will have very competitive cure rates when compared to the other isotopes and treatment options available to prostate cancer patients," she said. "We have had no failures [cancer recurrences] to date of which we are aware. The data is showing positive outcomes related to patient quality of life and morbidity outcomes."

Intraocular melanoma is most common in people over the age of 40 and is most commonly detected in routine eye exams when the pupils are dilated. The course of therapy is dictated by the size of the lesion, and whether the cancer has spread throughout the eye or beyond.

"Brachytherapy has been most effective for small- to medium-sized tumors," said Rivard. "Under those conditions, we anticipate that in most cases patients can be cured and their vision saved using brachytherapy."

The seeds are made to a physician's prescription for specific patients and are not made in quantity, according to IsoRay. The complete procedure including seeds, hospital charges, and physician's charges are typically between $30,000 to $50,000 based on the hospital or ASC, Woods said.

"This procedure using Cesium-131 is reimbursed by Medicare and all insurance companies," Woods said. "We have our own codes with Medicare. and we were just given the best reimbursement of all the isotopes in prostate brachytherapy by Medicare under their new reimbursement methodology for 2008."

In October, IsoRay signed a letter of intent with International Brachytherapy (IBt; Seneffe, Belgium) to form a global strategic alliance focusing on worldwide sales of brachytherapy solutions in the treatment of prostate cancer and other malignant-tissue cancers.

Major elements of the proposed alliance included the future marketing of IsoRay's brachytherapy seeds and Iodine-125 brachytherapy seeds in Russia. It includes planned distribution in 19 European countries using IBt's established distribution channels.

In early 2007, IsoRay raised $26 million in an equity financing led by Punk, Ziegel & Company and Maxim Group (MDD, March 26, 2007).

"We aren't currently looking to raise more money," Woods said, though the company is continuing to pursue other cancer applications for the technology.

"We are currently looking into other organs and disease sites. Areas like lung, breast, pancreas, skin, etc. We will continue to move into other areas of treatment that make sense for patients — and for IsoRay."

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