Biomoda Clinical Trial Adds Longitudinal Study to Protocol
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ALBUQUERQUE, N.M., Sept. 14, 2009 (GLOBE NEWSWIRE) -- Biomoda, Inc.'s
(OTCBB:BMOD) (www.biomoda.com) Phase II clinical trial to screen military
veterans for early-stage lung cancer has been enhanced to include a longitudinal
component, which will provide additional data on the efficacy of the Biomoda
diagnostic.
"Study participants whose initial results indicated areas of concern -- the
presence of nodules on the lungs or a positive read for cancer cells -- have
been asked to return for follow-up screening," commented John J. Cousins,
President and Chief Executive Officer of Biomoda, Inc. "The ability to monitor
study participants over the long term will no doubt result in a better medical
outcome for them as well as provide invaluable data for Biomoda as we prepare
for Phase III pivotal trials and FDA approval."
The Biomoda diagnostic, trademarked under the name CyPath(R), is based on a
patented porphyrin-based compound that binds to cancer cells and fluoresces red
under ultraviolet light. The original protocol for ongoing clinical trials
focused on the use of the assay as a diagnostic.
"Staying in contact with study participants and monitoring their lung health
will help us expand the utility of the CyPath(R) assay beyond early diagnosis to
actually measuring the success of treatment," Cousins said. "We will eventually
be able to tell patients how effectively their therapy is targeting their
cancer."
Biomoda's Phase II clinical trial is being conducted in partnership with the New
Mexico Department of Veterans Services (NMDVS) and the New Mexico Institute of
Mining and Technology (NM Tech). To date, more than 500 military veterans have
enrolled in the program. Under the guidance of a respiratory therapist, study
volunteers provide a deep-lung sputum sample which is screened for cancer cells
with both the CyPath(R) assay and traditional Pap staining. Participants also
undergo a computed tomography (CT) scan.
The current study will be expanded to include up to 3,500 patients for the Phase
III pivotal clinical trial. Biomoda expects results from these studies to be
sufficient for FDA approval by 2011.
Based in Albuquerque, New Mexico, Biomoda, Inc. is a cancer diagnostics company
focused on the development of accurate, inexpensive, and noninvasive in-vitro
tests for the early detection of cancer.
For more information on Biomoda, check the website at www.biomoda.com and follow
Biomoda on Facebook and Twitter.
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CONTACT: Biomoda, Inc.
John Cousins
505.821.0875
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