Monday April 30, 2012

PITTSFIELD -- Nuclea Biotechnologies has entered into a research partnership with the Stratton Veterans Administration Medical Center in Albany, N.Y. to test a biomarker's effectiveness in diagnosing the development of prostate cancer.

The partnership will involve a clinical trial in which Nuclea will evaluate how a biomarker known as Fatty Acid Synthase (FAS) can predict the behavior of prostate cancer in specific populations, such as military veterans, said Nuclea President and CEO Patrick J. Muraca.

Nuclea has filed for pre-market guidance with the Food and Drug Administration for its prostate monitoring diagnostic test showing that FAS levels are predictive of metastatic risk.

Biomarkers are biological molecules found in blood, other body fluids, or tissues, that can signal either a normal or abnormal process, or a condition or disease, according to the National Cancer Institute. They can also be used to see how well the body responds to a treatment for either a disease or a condition.

Prostate cancer is the most common cause of death from cancer for men over the age of 75. Larry Kaminsky, chief of staff for Stratton's research team, said the clinical test will take a year to complete.

"If this works it will be a monumental discovery," Kaminsky said, "because right now when a man is diagnosed with prostate cancer there's no way to determine if it will grow slowly or rapidly.

"The test would tell you if it's


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a rapidly developing cancer that needs to be taken care of immediately," he said. "Unfortunately, we don't have that ability right now."

Although prostate cancer is rarely found in males under the age of 40, it is prevalent in those between 55 and 70, Muraca said. Men over the age of 60 are at the highest risk. Also at risk are men who have been exposed to Agent Orange, a herbicide containing trace amounts of the toxic contaminant dioxin that was used to defoliate forests during the Vietnam War.

"What better population to study than veterans, especially from the Vietnam era," Muraca said. "Albany Stratton sees a lot of prostate patients.

"We're expanding the use of fatty acid for prostate cancer, and the way we can do that is to partner with the VA hospital because they have a large group of patients to do this with."

Nuclea, which has offices in Pittsfield and Worcester, develops and commercializes diagnostic tests for colon, breast, leukemia, lung and prostate cancer, in addition to doing research. This is Nuclea's first partnership with a veterans administration medical center.

John F. Downing, the president and CEO of the Soldier On veterans facility in Pittsfield, brought the two parties together, Muraca said.

Muraca said Nuclea plans to hire two employees in Pittsfield and one at Stratton to help the medical center with the test. Kaminsky said the testing won't begin until the staffing is in place.

"This is the first step," Kaminsky said. "At the end we should have a pretty good idea about whether it works or not."

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