Biomoda, Inc. (OTC Bulletin Board: BMOD), a diagnostics company focused on the development of accurate, inexpensive and noninvasive in-vitro tests for the early detection of cancer, has met its recruitment goal for New Mexico veterans with a history of heavy smoking required to complete the Phase II clinical trial of Biomoda's early-stage diagnostic for lung cancer. The next stage of the Phase II trial calls for Biomoda to begin testing samples from already-diagnosed lung cancer patients in accordance with the study protocol approved by the U.S. Food and Drug Administration (FDA).
"More than 500 veterans volunteered to be screened with the Biomoda assay. It has been heartening to see so many men and women who served their country in the armed forces willing to help once again by participating in this important study," said John Cousins, President of Biomoda. "The study is not complete, but we are pleased with the progress to date and expect to have final data in the first half of 2010."
The Biomoda diagnostic, trademarked under the name CyPath®, is based on a patented porphyrin-based compound that binds to cancer cells and fluoresces red under ultraviolet light. Under the guidance of a respiratory therapist, study volunteers provide a deep-lung sputum sample that is screened for cancer cells with both the CyPath® assay and traditional Pap staining. Participants also undergo a CT scan.
Dr. Thomas Bauer, chief of thoracic surgery at the Helen F. Graham Cancer Center, Christiana Care Health System, in Delaware, is the Principal Investigator overseeing the Phase II clinical trial. He has lead several lung and esophageal cancer studies and heads up Christiana's participation in the International Early Lung Cancer Action Program (I-ELCAP).
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