ALBUQUERQUE, NM--(Marketwire - March 09, 2009) - Biomoda, Inc. (OTCBB: BMOD), a medical diagnostics company based in Albuquerque, received approval from an independent Institutional Review Board (IRB) to begin Phase I clinical trials of its cytology-based screening technology for early detection of cancer.
IRB review protects research subjects by reviewing the study protocol to make sure it adheres to U.S. Food and Drug Administration (FDA) and U.S. Department of Health and Human Services regulations, that risks to participants are minimized and acceptable in light of the possible benefits, that the informed consent document is accurate, and that the research is conducted in an ethical manner.
Citing the IRB’s approval of Biomoda’s protocol as a significant step forward, Biomoda President and CEO John Cousins said, “This not only launches our Phase I clinical study, but it also puts us in a position to have a meaningful impact on people’s lives today. Our initial study is directed at military veterans who are at high risk for developing lung cancer. If our screening reveals early-stage cancer in one of our volunteers, that person’s chance of being alive five years from now goes from 15 percent to 80 percent, all because of early diagnosis and treatment.” It is our intent in this pilot program to identify five to ten such cases and have a dramatic impact on saving lives here in New Mexico now.
Working closely with the New Mexico Department of Veterans Services and the New Mexico Institute of Mining and Technology, Biomoda will begin recruiting volunteers for the study from New Mexico’s veteran population. Volunteers must be “20 pack year” smokers, individuals who have smoked one pack a day for 20 years or two packs a day for 10 years.
The study will initially enroll approximately 200-300 participants who will provide a deep-lung sputum sample under the guidance of a respiratory therapist. Each volunteer will also undergo a computed tomography (CT) scan, currently the standard of care for early detection of lung cancer. Later this year, the study will expand to 2,500 volunteers.
“Our internal testing on a small sample of patients has shown 100 percent accuracy. With the IRB approval, we can now expand that sample to a statistically significant number of patients which we believe will push us to final FDA approval and commercialization,” Cousins said.
Dr. Thomas L. Bauer, thoracic surgeon and cancer researcher with the Christiana Care Health System in Delaware, is the national Principal Investigator (PI) overseeing the Biomoda study. Bauer has led several lung and esophageal cancer studies and heads up Christiana’s participation in the International Early Lung Cancer Action Program (I-ELCAP). Bauer will work with Dr. Lara Patriquin, a diagnostic radiologist in Albuquerque, who has agreed to serve as the local PI for the study.
Biomoda’s non-invasive diagnostic is based on a patented porphyrin application that preferentially binds to cancerous or aberrant cells extracted from lung sputum samples. Cancerous cells glow red under fluorescent light. The cytology-based assay is designed for cancer screening of large populations at a reasonable cost with expected commercial accuracy of at least 90 percent.
Contact:
John Cousins
505.821.0875
