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.
Biomoda