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ALBUQUERQUE, N.M., Sept. 14, 2009 (GLOBE NEWSWIRE)
-- Biomoda, Inc.'s (OTCBB:BMOD
- News)
(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.
CONTACT:
Biomoda, Inc.
John
Cousins
505.821.0875
jjcousins@gmail.com
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