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.