BMOD's TCPP was originally invented and developed by the Regents of the University of California and the U.S. Department of Energy. Then the patents were transferred to LOS ALAMOS NATIONAL SECURITY. Then BMOD licensed it from Los Alamos. BMOD has added multiple patents to this original work they acquired from Los Alamos and have moved this from concept to FDA trials.
US F 53999990 A (Patent of invention)
PRS Date : 1991/08/29
PRS Code : AS
Code Expl.: ASSIGNMENT
NEW OWNER : UNITED STATES OF AMERICA, THE, AS REPRESENTED BY T
FURTHER INFORMATION : ASSIGNMENT OF ASSIGNORS INTEREST.;ASSIGNORS:COLE, DEAN A.;MOODY, DAVID C., III;REEL/FRAME:005818/0746;SIGNING DATES FROM 19900614 TO 19900724
PRS Date : 1992/09/08
PRS Code : AS
Code Expl.: ASSIGNMENT
NEW OWNER : REGENTS OF THE UNIVERSITY OF CALIFORNIA, THE
EFFECTIVE DATE : 19920821
FURTHER INFORMATION : ASSIGNMENT OF AN UNDIVIDED HALF INTEREST. SUBJECT TO LICENSE RECITED.;ASSIGNOR:UNITED STATES OF AMERICA, THE, AS REPRESENTED BY THE UNITED STATES DEPARTMENT OF ENERGY.;REEL/FRAME:006274/0638
PRS Date : 2003/09/16
PRS Code : AS
Code Expl.: ASSIGNMENT
NEW OWNER : U.S. DEPARTMENT OF ENERGY, DISTRICT OF COLUMBIA
EFFECTIVE DATE : 20030410
FURTHER INFORMATION : CONFIRMATORY LICENSE;ASSIGNOR:REGENTS OF THE UNIVERSITY OF CALIFORNIA, THE;REEL/FRAME:013974/0460
PRS Date : 2006/05/18
PRS Code : AS
Code Expl.: ASSIGNMENT
NEW OWNER : LOS ALAMOS NATIONAL SECURITY, LLC, NEW MEXICO
EFFECTIVE DATE : 20060410
FURTHER INFORMATION : ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:REGENTS OF THE UNIVERSITY OF CALIFORNIA, THE;REEL/FRAME:017914/0559
Government Interests
This invention is the result of Contract No. W-7405-ENG-36 between the Regents of the University of California and the U.S. Department of Energy.
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In 1992 Biomoda exclusively licensed the TCPP patent from Los Alamos National Laboratories (LNAL) for lung cancer diagnosis and treatment.
Since then the company has initiated internal and external testing of TCPP on various cancers and expanded known their research into what is called the CyPath Lung Cancer Assay.
Tetrakis Carboxy Phenyl Porphine (TCPP) is a porphyrin that binds to cancer cells. Porphyrins are naturally occurring pigments that fluoresce red when exposed to UV light.
TCPP has been shown to bind to cancerous and precancerous cells in both patient samples and tissue cultures.
Biomoda has optimized the labeling solution, known as CyPath, for lung cancer detection so that a maximum color differential between TCPP exposed cancer cells and normal cells exists. Simply put, a cancer cell will appear bright red while other types of cells will appear white/green under a microscope with UV light.
Even in the earliest studies conducted, TCPP consistently identified pre-cancerous and cancer cells in patient samples.
In 1992, LANL and St. Mary's Hospital conducted a pilot study using sputum (phlegm) samples from 12 uranium miners. PAP analysis had shown that eight of the 12 miners had lung cancer. LANL did a blind TCPP analysis of the 12 samples and correctly identified the eight lung cancer patients. The LANL study also identified one of the samples from a patient without lung cancer as positive. Further analysis of that same sample showed that the patient was misdiagnosed by the PAP analysis and did indeed have lung cancer.
In 1998, LungCheck conducted a study for Biomoda. For this study, LungCheck used 52 samples from patients with dysplasia, carcinoma in situ (CIS) and lung cancer (adenocarcinoma, squamous cell carcinoma, small cell carcinoma) and seven samples from patients with metaplasia as "controls." The sensitivity, a measurement of accuracy, for this study was calculated at 96.2 percent.
In addition to Independent Validation Studies currently underway, Biomoda is simultaneously conducting an internal validation study using prospective samples collected from clinical sites in the US and Russia.
Biomoda's findings indicate that this assay can be used to distinguish cancer patients from controls and to distinguish smokers from controls and cancer patients.
Although the company is concentrating its efforts on early detection of lung cancer, studies have lead to an indication that there may be several other potential applications for the TCPP technology, such as cervical cancer based on cervical swab samples, breast cancer based on ductal lavage samples, and bladder cancer based on urine samples. In addition, Leukemia could potentially be diagnosed with TCPP labeling solution, CyPath, using blood or bone marrow. There is also the potential to use CyPath for histological examination of biopsy samples for all cancers. There are three commonly used techniques for preparing slides for cytology examination. Biomoda has qualified CyPath with each of these techniques.
Biomoda has exclusively licensed one patent from Los Alamos National Laboratories (LANL). The patent (US Patent Number: 5,162,231) is for the use of TCPP and other porphyrins as fluorescence tracers for cancer cells. In addition, Biomoda has received (US Patent Number: 6,838,248) for methods of detecting pre-cancerous and cancerous cells using TCPP. The company has three other patents filed and pending.
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