BMOD All-in-one PR's Updated September 7th
Biomoda Signs Research Agreement with Saccomanno Research Institute
September 7, 2010: ALBUQUERQUE, N.M.--(BUSINESS WIRE)--Cancer diagnostics company Biomoda, Inc. (OTCBB: BMOD - News) (www.biomoda.com) is working with the Saccomanno Research Institute to advance Biomoda’s patented system for measuring the photon emission rate of CyPath®-stained cells to detect early-stage lung cancer.
Biomoda’s CyPath® labeling solution for the early detection of cancers is based on meso-tetra (4 carboxyphenyl) porphine or TCPP, a porphyrin compound that binds to cancer cells and fluoresces under specific frequencies of light. Participants in Biomoda’s pilot clinical study, which is nearing completion, provided deep-lung sputum samples to be labeled with the CyPath® solution and viewed under fluorescent microscopy. The samples are also screened for cancer with Pap stain analysis and CT scans. Pending FDA approval, CyPath® is for investigational use only.
“It is especially appropriate that Biomoda is working with the Saccomanno Research Institute since its namesake, the late Dr. Geno Saccomanno, pioneered the development of sputum cytology for the early detection of lung cancer,” said John Cousins, President of Biomoda. Working at St. Mary’s Hospital and Medical Center in Grand Junction, Colorado, Saccomanno originally focused on the prevalence of lung cancer in the uranium miners who lived in the area. He conducted nearly 50 years of research on the diagnostic applications of sputum cytology.
“Under the direction of Dr. Marty Jacobson, the Saccomanno Institute will provide expertise needed for the pivotal clinical study, which is the next step toward commercializing the CyPath® technology as a cancer screening tool appropriate for large populations,” Cousins said. “We are delighted that Dr. Jacobson’s laboratory has joined our pivotal study team.”
About the Saccomanno Research Institute
Building on the work begun by Dr. Geno Saccomanno, Ph.D., M.D., the Saccomanno Research Institute focuses on genetic, environmental and occupational diseases affecting the population served by the St. Mary’s Hospital medical community. As a result of its history with the health risks of uranium mining, the Institute has conducted epidemiological and clinical studies of the genetics of disease susceptibility, early detection of disease and disease outcomes.
==================================================================
Biomoda to Participate in Rodman & Renshaw Annual Healthcare Conference in New York City
August 30, 2010: ALBUQUERQUE, N.M.--(BUSINESS WIRE)--Cancer diagnostics company Biomoda, Inc. (OTCBB: BMOD - News) (www.biomoda.com) today announced that John Cousins, President and CEO, will present on Biomoda’s proprietary CyPath® diagnostic assay for the detection of early-stage cancers at the Rodman & Renshaw 12th Annual Healthcare Conference in New York on Wednesday, September 15, 2010.
The Healthcare Conference is one of eight industry tracks featured at the Rodman & Renshaw Annual Global Investment Conference. Institutional investors, venture capitalists, private equity firms, business development executives and sophisticated private investors will have the opportunity to learn about Biomoda’s porphyrin-based CyPath® labeling solution that binds to cancer cells and causes them to fluoresce under specific frequencies of light.
Biomoda is concluding the pilot clinical trial on CyPath® as a diagnostic for early-stage lung cancer. Pending Food and Drug Administration (FDA) approval, CyPath® is for investigational use only.
The Biomoda presentation is scheduled for 12:30 p.m. EDT on September 15 in the Spellman Salon, Fifth Floor, New York Palace Hotel.
About Biomoda
Biomoda (www.biomoda.com) is a cancer diagnostics company focused on the development of accurate, inexpensive and noninvasive tests for the early detection of cancer in large populations. In addition to its first product for lung cancer, diagnostic assays for cervical, breast, colorectal, bladder, and oral cancers are targeted for development.
About Rodman & Renshaw
Rodman & Renshaw is a full-service investment bank providing corporate finance, strategic advisory and related services to public and private companies across multiple sectors and regions. Rodman also provides research and sales and trading services to institutional investors.
==================================================================
Biomoda Allowed Patent in Canada
August 25, 2010: ALBUQUERQUE, N.M.--(BUSINESS WIRE)--Cancer diagnostics company Biomoda, Inc. (OTCBB: BMOD) (www.biomoda.com) has received a notice of allowance for a Canadian patent application for a method of using its proprietary porphyrin-based compound that binds to cancer cells and causes them to fluoresce under specific frequencies of light when viewed under a fluorescent microscope.
Allowed by the Canadian Intellectual Property Office, Canadian patent application 2,429,526, “Compositions and Methods for Detecting Pre-Cancerous Conditions In Cell And Tissue Samples Using 5, 10, 15, 20-Tetrakis (Carboxyphenyl) Porphine,” is similar to Biomoda’s U.S. patent 6,838,248, which was issued in 2005. Foreign equivalents are now effective in Canada, Mexico, Japan and Australia and are pending in Europe.
“With the World Health Organization reporting more than 5 million tobacco-related deaths every year, lung cancer mortality is clearly a global issue,” said Biomoda President John Cousins. “Protecting our intellectual property at the international level is the first step toward a global strategy for the commercialization and marketing of the CyPath® assay for early detection of lung cancer.”
The 5, 10, 15, 20-tetrakis (carboxyphenyl) porphine, or TCPP, is the foundation for several Biomoda product lines and medical diagnostics. The company is completing data analysis for the pilot clinical trial of its first product, an in-vitro test for the detection of early-stage lung cancer, in which study volunteers provide deep-lung sputum samples to be screened for cancer cells with the CyPath® assay. The company anticipates that results from the pilot study will provide the foundation for a pivotal clinical study leading to submission to the U.S. Food and Drug Administration (FDA) for approval of the commercial sale of Biomoda’s technology.
Biomoda is seeking FDA approval of its cytology-based screening technology as a Class III medical device. Pending FDA approval, CyPath® is for investigational use only. The company is also pursuing strategies to enter the European market, including filing for approval of a CE mark.
==================================================================
Biomoda Files Patent Application
July 20, 2010: ALBUQUERQUE, N.M.--(BUSINESS WIRE)--Cancer diagnostics company Biomoda, Inc. (OTCBB: BMOD - News) (www.biomoda.com) filed a U.S. patent application on a quantitative method for scoring cells labeled with the CyPath® assay to determine whether cells are dysplastic or carcinomic by measuring the photon emission rate.
Biomoda’s CyPath® reagents for the early detection of cancers is based on meso-tetra (4 carboxyphenyl) porphine or TCPP, a porphyrin compound that binds to cancer cells and fluoresces under specific frequencies of light. The new patent application provides a system for verifying the spectral signature of TCPP optically and measuring the photon emission rate of TCPP-stained cancerous and precancerous cells.
“We now have an objective methodology that can be used by lab technicians anywhere in the world to accurately and inexpensively read CyPath® reagent-labeled tissue samples,” said Biomoda President John Cousins. “Previously, we had to rely on cytopathologists to look at each and every sample to determine whether there were cancer cells. This patent gives us a measurable, quantitative system that opens the door for the CyPath® assay to be used to screen large populations for cancer and pre-cancerous conditions. Diagnosing cancer even before a tumor has formed will have an exponential effect on survivability.”
Biomoda is nearing completion of the pilot study on the CyPath® assay as a diagnostic for early-stage lung cancer. Pending Food and Drug Administration approval, CyPath® reagents are for investigational use only.
Titled “System and Method for Analyzing Samples Labeled with 5, 10, 15, 20 Tetrakis (4-Carboxyphenyl) Porphine (TCPP),” the U.S. and foreign patent applications build on the science underlying Biomoda’s cytology-based diagnostic. Originally developed at Los Alamos National Laboratory, the TCPP platform is the foundation for several Biomoda product lines still in the development stage.
==================================================================
Biomoda Completes Patient Enrollment and Sample Collection in Pilot Study
Thursday June 24, 2010, 9:20 am EDT:ALBUQUERQUE, N.M.--(BUSINESS WIRE)--Cancer diagnostics company Biomoda, Inc. (OTCBB: BMOD - News) (www.biomoda.com) today announced it completed patient enrollment and sample collection in a pilot study to determine the clinical sensitivity and specificity of its CyPath® labeling solution for the early detection of lung cancer. Top-line data and results will be released when available.
Biomoda is seeking Food and Drug Administration (FDA) approval of its screening technology as a Class III medical device. In addition to FDA approval, Biomoda President John Cousins said the company is pursuing a CE Mark to commercialize CyPath® in Europe. CyPath® is currently for investigational use only.
“This is a significant milestone for our CyPath® diagnostic test,” Cousins said. “Now that enrollment and collection are complete, the study team is evaluating data in preparation for publishing results when analysis is complete. We expect the results from this single-blind, non-randomized clinical trial to lead to the launch of the Phase III pivotal trial.”
The Principal Investigator overseeing the CyPath® study is Dr. Thomas Bauer, chief of thoracic surgery at the Helen F. Graham Cancer Center, Christiana Care Health System, in Delaware as well as associate professor of surgery at Jefferson Medical College and adjunct assistant professor of biological sciences at the University of Delaware.
The protocol approved for the Phase II pilot study includes two cohorts: a larger group of patients who represent a high-risk population of heavy smokers and a smaller group of patients who had been diagnosed with lung cancer but had not yet begun treatment for the disease. The first cohort was recruited among male and female veterans of the armed services who are known to be at higher risk for developing lung cancer than the general population.
==================================================================
Biomoda Awarded Patent in Mexico
6/7/10: Cancer diagnostics company Biomoda, Inc. (OTCBB: BMOD) (www.biomoda.com) has been granted a Mexican patent for its proprietary porphyrin-based compound that binds to cancer cells and causes them to fluoresce red under ultraviolet light.
Issued by the Instituto Mexicano de la Propiedad Industrial (IMPI), Mexican patent #269352, "Compositions and Methods for Detecting Pre-Cancerous Conditions In Cell And Tissue Samples Using 5, 10, 15, 20-Tetrakis (Carboxyphenol) Porphine," is similar to Biomoda's U.S. patent 6,838,248, which was issued in 2005. Foreign equivalents are now effective in Mexico, Japan and Australia and are pending in Europe and Canada.
"This patent represents another step in protecting our intellectual property rights internationally," said Biomoda President John Cousins. "We are strategically building our IP portfolio with an eye on the eventual commercialization and marketing of our CyPath(R) diagnostic assay to address the global issue of lung cancer mortality."
The 5, 10, 15, 20-tetrakis (carboxyphenyl) porphine, or TCPP, is the foundation for several Biomoda product lines and medical diagnostics. The company is concluding Phase II clinical trials of its first product, an in-vitro test for the detection of early-stage lung cancer, in which study volunteers provide deep-lung sputum samples to be screened for cancer cells with the CyPath(R) assay. Results are compared to CT scans and Pap stains read by independent radiologists and cytopathologists, respectively, to confirm accuracy.
==================================================================
Biomoda and Obio Sign MOU to Expand Lung Cancer Screening Program
6/2/10: Cancer diagnostics company Biomoda, Inc. (OTCBB: BMOD) (www.biomoda.com) and Obio, a corporation formed to pursue public and private funding for cancer research in Ohio, signed a memorandum of understanding (MOU) to establish a CLIA-certified Biomoda clinical laboratory in Ohio to support ongoing research and development on Biomoda's porphyrin-based assay for the detection of early-stage cancer.
The Clinical Laboratory Improvement Amendments (CLIA) were passed by Congress in 1988 to establish standards for laboratory testing and ensure the accuracy and reliability of patient test results. Laboratories that meet CLIA standards are certified by the U.S. Department of Health and Human Services.
"We are ready to expand our strategic alliance with Obio to include operational facilities that will put us in closer contact with Ohio's top-rated medical, scientific and technical resources," said Biomoda President John Cousins. "Ohio is proactively attracting promising biotech companies to the state through public initiatives that support research and commercialization. This fits perfectly with our strategic plan for taking CyPath(R) into the marketplace."
Biomoda currently is conducting clinical trials of its CyPath(R) labeling solution, an inexpensive, noninvasive assay designed to identify early-stage lung cancer by binding to cancer cells and causing them to fluoresce under ultraviolet light. Biomoda is seeking Food and Drug Administration (FDA) approval of its screening technology as a Class III medical device. CyPath(R) is currently for investigational use only.
Initially, the lab formed in partnership between Biomoda and Obio could employ up to 12 trained technicians to prepare fluid and tissue samples for immersion into the CyPath(R) labeling solution and subsequent screening under an ultraviolet microscope. Pending FDA approval, widespread commercialization of the CyPath(R) product would require significant expansion of the lab facility, creating additional jobs and a positive impact on Ohio's economy.
==================================================================
LifeTech Capital Initiates Research Coverage of Biomoda
05.04.2010 — 9:20 am: ALBUQUERQUE, N.M.–(BUSINESS WIRE)–Biomoda, Inc. (OTCBB: BMOD – News) (www.biomoda.com), a cancer diagnostics company, is pleased to announce that LifeTech Capital, a division of Aurora Capital LLC, has initiated independent research coverage on Biomoda with a “Strong Speculative Buy” recommendation and a 12- to 18-month price target of $1.00 per share. The report, which was authored by Stephen M. Dunn, Senior Managing Director, Research and William D. Dawson, Senior Vice President, Research for LifeTech Capital, is available online at www.lifetechcapital.com/reports.htm.
LifeTech Capital is an investment bank that specializes in the biotechnology and medical technology industries. Biomoda does not endorse the reports, projections or statements of any analyst.
==================================================================
Biomoda Announces up to $2.0 Million Private Placement
03/17/2010 — 8:00 am: Albuquerque, NM (March 17, 2010) – Cancer diagnostics company Biomoda, Inc. today announced that it has entered into agreements with a syndicate of institutional investors for up to $2.0 million. LifeTech Capital, a division of Aurora Capital LLC, acted as the exclusive placement agent for the financing.
“We are extremely pleased with the outcome of this round of financing,” said John Cousins, Biomoda president and chief executive officer. “The institutions that participated in this investment speak volumes about the promise of our technology and the validity of our business model and strategy. This is a significant stamp of approval from prestigious investment funds with a strong history of success in the biotech sector.”
Biomoda’s CyPath® diagnostic assay which binds to cancer cells and causes them to fluoresce red under ultraviolet light is currently in clinical trials as a diagnostic for early-stage lung cancer. Pending U.S. Food and Drug Administration (FDA) clearance, CyPath® is for investigational use only.
“Proceeds from this financing will allow us to continue our clinical trials, submit our findings to the FDA for clearance as a Class III medical device and begin commercialization of a breakthrough technology for the early detection of cancer,” Cousins said. The initial funding is $1,000,000, with the investors having the right to invest an additional $1,000,000.
Cousins praised LifeTech Capital, (www.lifetechcapital.com) a division of Aurora Capital LLC, (www.auroracapital.com) for bringing the transaction to a successful close. “The investment banking team at LifeTech specializes in the unique needs of the biotech and medical technology industries. They understand how to analyze the future value of technologies like ours and match companies with the right investors,” Cousins said.
==================================================================
Biomoda Awarded Patent Securing Assay Formulation and Use
03.02.2010 — 2:41 pm: Albuquerque, NM (March 2, 2010) -Biomoda, Inc. (OTC BB: BMOD) (www.biomoda.com) was today awarded U.S. patent 7,670,799, entitled, “Composition and Method for Making 5, 10, 15, 20- Tetrakis (Carboxyphenyl) Porphine (TCPP)” directed to Biomoda’s proprietary TCPP formulation for cancer and pre-cancer cell identification and analysis and a method of making the TCPP formulation.
“This new patent further strengthens and secures Biomoda’s market position for early cancer detection,” said John Cousins, Biomoda’s President. “It reflects the continuing and successful research and development that is an essential part of our Company.”
Biomoda’s patented cancer and pre-cancer cell based diagnostic assay is trademarked under the name CyPath®. Patent 7,670,799 together with Biomoda’s U.S. patents 6,838,248, entitled “Compositions and Methods for Detecting Pre-Cancerous Conditions in Cell and Tissue Samples Using 5, 10, 15, 20-Tetrakis (Carboxyphenyl) Porphine” and 7,384,764, entitled “Methods for Prognosing Response to Cancer Therapy with 5, 10, 15, 20-Tetrakis (Carboxyphenyl) Porphine” protect the method of detecting cancerous conditions and prognosing responses to cancer therapy with TCPP.
The TCPP platform is the foundation for CyPath®, an in-vitro test for the detection of early-stage lung cancer that currently is completing Phase II clinical trials. Study volunteers have provided deep-lung sputum samples to be screened for cancer with the CyPath® assay in the Biomoda laboratory. Results are compared to CT scans and Pap stains read by independent radiologists and cytopathologists, respectively, to confirm accuracy.
Biomoda is seeking Food and Drug Administration (FDA) approval of CyPath®, its cytology-based screening technology as a Class III medical device. Multi-site Phase III trials, the final step before FDA approval, are scheduled to begin in 2010.
==================================================================
Biomoda Partners with Christiana Care to Complete Pilot Study on Cancer Diagnostic
12.10.2009 — 8:00 am: ALBUQUERQUE, N.M.–(BUSINESS WIRE)–Cancer diagnostics company Biomoda, Inc. today announced that The Helen F. Graham Cancer Center associated with Christiana Care Health System, a screening site for the International Early Lung Cancer Program (I-ELCAP), will recruit a cohort of patients diagnosed with lung cancer to participate in the final stage of the Phase II pilot study of the investigational CyPath® assay, an early-stage diagnostic test for lung cancer.
“Running our diagnostic test on a control group of patients who are known to have lung cancer but have not yet started therapy will provide the final data we need to complete the pilot phase of our study,” said Biomoda President John Cousins. “Christiana Care is a national role model for both patient care and cancer research. We could not ask for a better partner.”
Dr. Thomas Bauer, chief of thoracic surgery at Christiana Care’s Helen F. Graham Cancer Center, is the Principal Investigator (PI) for the Biomoda study. Bauer has led several lung and esophageal cancer studies and heads up Christiana’s participation in the I-ELCAP. Christiana Care’s Institutional Review Board reviewed the Biomoda study protocol to ensure compliance with scientific, regulatory and ethical standards.
CyPath® is an investigational-use-only diagnostic based on a patented molecular marker that binds to cancer cells and fluoresces red under ultraviolet light. More than 500 individuals at high risk for developing lung cancer have volunteered to provide deep-lung sputum samples to be screened for cancer with Pap stain analysis and CT scans. These diagnostic results are then compared to results from the sputum samples after they have been treated with the CyPath® labeling solution. The control group recruited at Christiana Care will help measure the sensitivity and specificity of the CyPath® assay.
Biomoda is seeking Food and Drug Administration (FDA) approval of its cytology-based screening technology as a Class III medical device under the Pre-Market Approval (PMA) process. “With Christiana’s participation, we believe we could have Phase II results as early as the end of January 2010. Based on feedback from the FDA to date, we anticipate no delays in moving forward with the pivotal multi-site Phase III trials,” Cousins said.
==================================================================
Biomoda Awarded New Patent
11.03.2009 — 8:00 am: ALBUQUERQUE, N.M.–(BUSINESS WIRE)–Biomoda, Inc., an Albuquerque-based cancer diagnostics company, announces that it has received notice of allowance for a U.S. Patent protecting the proprietary formula for the composition that binds to cancer cells which is utilized in Biomoda’s screening assay for the early detection of cancer.
The U.S. Patent entitled “Method for Making 5, 10, 15, 20-Tetrakis (Carboxyphenyl) Porphine (TCPP) Solution and Composition Comprising TCPP,” describes the new formulation of the Biomoda assay trademarked under the name CyPath®.
“This patent basically gives Biomoda a lock on the ‘recipe’ for the TCPP Labeling Solution,” said Biomoda President John Cousins. “Our formulation moves beyond the original work done on TCPP at Los Alamos National Laboratory and incorporates the cutting-edge science we are doing in our own lab.”
TCPP is the foundation for several Biomoda product lines and medical diagnostics. The company’s first product, an in-vitro test for the detection of early-stage lung cancer, is currently in Phase II clinical trials. Study volunteers provide deep-lung sputum samples to be screened for cancer cells with the CyPath® assay in the Biomoda lab. Results are compared to CT scans and Pap stains read by independent radiologists and cytopathologists, respectively, to confirm accuracy.
Biomoda is seeking Food and Drug Administration (FDA) approval of its cytology-based screening technology as a Class III medical device. Multi-site Phase III trials, the final step before FDA approval, are scheduled to begin in early 2010.
In addition to U.S. patents (6,838,248 and 7,384,764), Biomoda also holds patents for its proprietary technology in several foreign countries.
==================================================================
Biomoda Prepares for Phase III Clinical Trials
10.28.2009 — 8:00 am: ALBUQUERQUE, N.M. October 28, 2009 –Medical diagnostics company Biomoda, Inc. is taking preliminary steps to launch multisite Phase III clinical trials of its in-vitro diagnostic for early-stage lung cancer, trademarked under the name CyPath®.
“As the Phase II trial wraps up, we are making sure that all the pieces are in place to move immediately to a nationwide Phase III,” Biomoda President John Cousins said. “Most significantly, Dr. Thomas Bauer, the Principal Investigator (PI) overseeing Phase II, has agreed to continue in the same role for our Phase III trials. Dr. Bauer is widely recognized as one of the top lung cancer researchers in the field, and we are privileged to be working with him.”
Bauer, chief of thoracic surgery at the Helen F. Graham Cancer Center, Christiana Care Health System, and head of Christiana’s participation in the International Early Lung Cancer Action Program (I-ELCAP), is coordinating site selection for the final phase of testing on the CyPath® assay. Bauer’s work with Biomoda follows the I-ELCAP Enrollment and Screening Protocol, and all sites selected for the Phase III trials will be I-ELCAP approved.
Cousins said that Biomoda is finalizing the protocol for its Phase III trials for submission to an Institutional Review Board (IRB) in early 2010. IRB review protects research subjects by making sure the study protocol 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.
Biomoda is seeking FDA approval of its cytology-based screening technology as a Class III medical device under the Pre-Market Approval (PMA) process. “When Phase II results are complete, probably by the end of January 2010, we will report them immediately to the FDA along with the pre-IDE (Investigational Device Exemption) filing,” Cousins said. “Based on feedback from the FDA to date, we anticipate no delays in moving forward with Phase III.”
Biomoda is a cancer diagnostics company focused on the development of accurate, inexpensive and noninvasive tests for the early detection of cancer. The CyPath® assay is based on a patented porphyrin-based compound that binds to cancer cells and fluoresces red under ultraviolet light
==================================================================
Biomoda Enters Final Stage of Patient Testing for Phase II Lung Cancer Clinical Study
10.23.2009 — 8:00 am: ALBUQUERQUE, N.M., Oct. 23 — Biomoda, Inc., a diagnostics company focused on the development of accurate, inexpensive and noninvasive in-vitro tests for the early detection of cancer, has met its recruitment goal for New Mexico veterans with a history of heavy smoking required to complete the Phase II clinical trial of Biomoda’s early-stage diagnostic for lung cancer. The next stage of the Phase II trial calls for Biomoda to begin testing samples from already-diagnosed lung cancer patients in accordance with the study protocol approved by the U.S. Food and Drug Administration (FDA).
“More than 500 veterans volunteered to be screened with the Biomoda assay. It has been heartening to see so many men and women who served their country in the armed forces willing to help once again by participating in this important study,” said John Cousins, President of Biomoda. “The study is not complete, but we are pleased with the progress to date and expect to have final data in the first half of 2010.”
The Biomoda diagnostic, trademarked under the name CyPath®, is based on a patented porphyrin-based compound that binds to cancer cells and fluoresces red under ultraviolet light. Under the guidance of a respiratory therapist, study volunteers provide a deep-lung sputum sample that is screened for cancer cells with both the CyPath® assay and traditional Pap staining. Participants also undergo a CT scan.
Dr. Thomas Bauer, chief of thoracic surgery at the Helen F. Graham Cancer Center, Christiana Care Health System, in Delaware, is the Principal Investigator overseeing the Phase II clinical trial. He has lead several lung and esophageal cancer studies and heads up Christiana’s participation in the International Early Lung Cancer Action Program (I-ELCAP).
Based in Albuquerque, NM, Biomoda is a cancer diagnostics company focused on the development of accurate, inexpensive and noninvasive in-vitro tests for the early detection of cancer.
==================================================================
Biomoda Engages Renowned Researcher to Lead Longitudinal Component of Lung Cancer Study
09.30.2009 — 8:00 am: ALBUQUERQUE, N.M., Sept. 30, 2009 (GLOBE NEWSWIRE) — Biomoda, Inc., a diagnostics company focused on the development of accurate, inexpensive, and noninvasive in-vitro tests for the early detection of cancer, announced Dr. Thomas Bauer will read the follow-up CT scans and other data on study participants as part of the longitudinal component of the research of the Phase II clinical trial of its assay. Dr. Bauer is the Principal Investigator (PI) overseeing the Phase II clinical trial of Biomoda’s early-stage diagnostic for lung cancer.
“Dr. Bauer’s work on our study is a significant step toward proving the usefulness of the CyPath(R) assay as an early screening tool for lung and other cancers,” Biomoda President John Cousins said. “Repeat screenings under the longitudinal part of the study will probably save lives in our study cohort as well as provide additional data critical to FDA approval of the assay.”
Dr. Bauer is chief of thoracic surgery at the Helen F. Graham Cancer Center, Christiana Care Health System, in Delaware as well as clinical assistant professor of surgery at Jefferson Medical College and adjunct assistant professor of biological sciences at the University of Delaware. He has led several lung and esophageal cancer studies and heads up Christiana’s participation in the International Early Lung Cancer Action Program (I-ELCAP).
I-ELCAP is a group of 52 institutions in nine countries dedicated to advancing the knowledge base for early detection and treatment of lung cancer. Dr. Bauer’s work with Biomoda follows the I-ELCAP Enrollment and Screening Protocol updated and published on Feb. 10, 2009.
“In addition to his thoracic surgery practice and his faculty positions, Dr. Bauer is widely recognized by his peers as one of the top lung cancer researchers in the field. We are extraordinarily lucky to have his expertise and experience on our study,” Cousins said.
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. Under the guidance of a respiratory therapist, study volunteers provide a deep-lung sputum sample that is screened for cancer cells with both the CyPath(R) assay and traditional Pap staining. Participants also undergo a CT scan.
Based in Albuquerque, N.M., Biomoda is a cancer diagnostics company focused on the development of accurate, inexpensive and noninvasive in-vitro tests for the early detection of cancer.
=================================================================
Biomoda Clinical Trial Adds Longitudinal Study to Protocol
09.14.2009 — 8:00 am: ALBUQUERQUE, N.M., Sept. 14, 2009 (GLOBE NEWSWIRE) — Biomoda, Inc.’s 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.
==================================================================
Biomoda Study Will Screen 500 New Mexico Veterans for Lung Cancer
08.04.2009 — 8:00 am: SANTA FE, N.M., Aug. 4, 2009 (GLOBE NEWSWIRE) — Biomoda, Inc., the New Mexico Department of Veterans Services, and the New Mexico Institute of Mining and Technology (NM Tech) appeared before the State Legislature’s Interim Tobacco Settlement Committee to report that 500 New Mexico veterans have committed to participate in a state-funded program for the detection of early-stage lung cancer based on Biomoda’s proprietary technology.
John Cousins, Biomoda president and CEO, told the legislators that the $1.65 million appropriated for the screening program has raised awareness among New Mexico veterans of the U.S. armed forces about their increased risk for developing lung cancer and the importance of early detection. Of the 500 volunteers for the program, more than 100 have completed the screening.
Biomoda’s diagnostic is based on a patented molecular marker originally developed at Los Alamos National Laboratory that preferentially binds to cancerous or aberrant cells and causes them to fluoresce under ultraviolet light. Under the guidance of a respiratory therapist, study volunteers provide a deep-lung sputum sample to be processed with Biomoda’s CyPath(r) assay in the Biomoda lab. Results are compared to a CT scan and PAP stains read by cytopathologists to confirm accuracy.
“This study will help us move the CyPath(r) technology closer to FDA approval and commercialization, bringing a non-invasive, accurate, and inexpensive tool for detecting cancer to market,” Cousins said. “The health benefits of the Biomoda diagnostic are obvious and have worldwide implications.”
NM Tech presented a scientific abstract on the Biomoda diagnostic at the 13th World Conference on Lung Cancer in San Francisco, CA, on August 2, 2009.
==================================================================
Biomoda Files For Fourth US Patent
07.27.2009 — 8:00 am: ALBUQUERQUE, N.M., July 27, 2009 (GLOBE NEWSWIRE) — Biomoda, Inc. an Albuquerque-based early cancer detection medical diagnostics company, has filed a new patent on a quantitative method for reading tissue samples for signs of malignant tumor cells, bringing the company’s U.S. patent portfolio to four total patents issued or pending.
Biomoda’s diagnostic for the early detection of various cancers is based on meso-tetra (4 carboxyphenyl) porphine or TCPP, a patented porphyrin compound that binds to cancer cells and fluoresces red under ultraviolet light. The new patent provides a system for verifying the spectral signature of TCPP optically and measuring the photon emission rate of TCPP labeled cancerous and precancerous cells.
“Until now, TCPP-labeled tissue samples have required the trained eye of a cytopathologist to determine whether there is cancer present,” said John Cousins, Biomoda president and chief executive officer. “This system gives us a measurable, quantitative way to make that determination based on a scientific phenomenon, the photon energy emission from each cell.”
Biomoda’s first product, an in-vitro test for the early detection of lung cancer, is currently in clinical trials. Under the guidance of a respiratory therapist, study volunteers provide a deep-lung sputum sample that is screened for cancer cells in the Biomoda lab under the protocol described in the new patent.
Titled “System and Method for Analyzing Samples Labeled with 5, 10, 15, 20 Tetrakis (4-Carboxyphenyl) Porphine (TCPP),” the patent builds on the science underlying Biomoda’s cytology-based diagnostic. Originally developed at Los Alamos National Laboratory and trademarked under the names CyPath(r) and CyDx(r), the TCPP platform is the foundation for several Biomoda product lines and medical tools still in the developmental stage.
Cousins said, “This patent represents a giant step forward in terms of making our cancer diagnostic available to large populations because trained technicians anywhere in the world will be able to process tissue samples accurately and inexpensively.”
In addition to the new U.S. patent, Biomoda was recently awarded patents for its proprietary technology in Japan and Australia.
=================================================================
New Mexico Tech to Present Biomoda Data at International Lung Cancer Conference
06.15.2009 — 8:00 am: Albuquerque, NM (June 15, 2009) – The New Mexico Institute of Mining and Technology (NM Tech) will present data from Biomoda, Inc. (OTCBB : BMOD) on its non-invasive, inexpensive and accurate diagnostic test for the early detection of lung cancer at the 13th World Conference on Lung Cancer in San Francisco, CA, July 31 to August 4, 2009.
NM Tech and two affiliated entities, the Institute for Complex Additive Systems Analysis (ICASA) and the Computational Analysis and Network Enterprise Solutions, LLC (CAaNES), are working with Albuquerque-based medical diagnostics company Biomoda, Inc. on the patented assay for early detection of cancer.
Dr. Srinivas Mukkamala, a senior research scientist with ICASA, will present an abstract titled “Non-Intrusive and Extremely Early Detection of Lung Cancer Using TCPP (Biomoda Lab Cultured Lung Cancer Data),” in poster format to the 7,000 lung cancer professionals expected to attend the conference. TCPP, or meso-tetra (4 carboxyphenyl) porphine, is the chemical compound underlying Biomoda’s patented diagnostic assay.
Currently in Phase II clinical trials, Biomoda’s diagnostic is a porphyrin application that preferentially binds to cancerous or aberrant cells extracted from deep lung sputum samples. Cancerous cells treated with Biomoda’s patented CyPath™ labeling solution fluoresce red under ultraviolet light.
Mukkamala’s presentation at the World Conference on Lung Cancer will focus on the computer modeling and data analysis work ICASA and CAaNES have done with Biomoda’s images and data. “Our work will allow Biomoda to automate the screening process, which is a critical step toward making the diagnostic available to large populations,” Mukkamala said. “The computer modeling will also enhance the accuracy of the assay.”
“The opportunity to present the Biomoda technology to the top clinicians and scientists in our field is a big step forward for us,” said John Cousins, Biomoda President and CEO. “Since only 16 percent of lung cancers today are diagnosed early enough to be cured, this audience will understand the tremendous life-saving potential of an easy, non-invasive, inexpensive and, above all, accurate screening tool for lung cancer.”
Sponsored by the International Association for the Study of Lung Cancer (IASLC), the World Conference on Lung Cancer is one of the largest international gatherings of professionals in the field, focusing on both research science and advances in the treatment of lung cancer, the leading cause of cancer deaths worldwide.
==================================================================
Over 400 Vets Enroll in Biomoda Lung Cancer Screening Program
06.09.2009 — 8:00 am: Albuquerque, NM (June 9, 2009) – More than 400 New Mexico veterans have volunteered to participate in a screening program for the early detection of lung cancer based on a non-invasive diagnostic tool developed by Biomoda, Inc. (OTC Bulletin Board: BMOD) and trademarked under the name CyPath™.
“The value of a study like this is two-fold,” said John Cousins, Biomoda President and CEO. “We are literally saving lives by identifying early-stage lung cancer in asymptomatic patients at the same time we are gathering the necessary data to receive FDA approval and move the diagnostic into the marketplace.”
Cousins reported that preliminary results of the screening program are trending in a positive direction, and several patients have already been referred for medical follow-up.
Biomoda expects to screen at least 3,500 participants in multiple sites over the course of the study. The initial focus is on veterans because they are 25 percent more likely to develop the disease and die from it than the general population. Funded by the New Mexico State Legislature and administered by the New Mexico Department of Veterans Services, “this study puts a spotlight on one of the most serious health issues facing the men and women who serve in uniform,” Cousins said. “Veterans we meet through our recruiting outreach are really appreciative of the opportunity to participate, to find out early if they have cancer or a pre-cancerous condition when there is still time for successful treatment and recovery.”
Unlike other diagnostics, the Biomoda assay is designed for routine screening of large populations at a reasonable cost and high accuracy. Under the guidance of a respiratory therapist, study volunteers provide a deep-lung sputum sample that is tested for cancer cells in the Biomoda lab. Results are compared to a computed tomography (CT) scan, currently the standard of care for detection of lung cancer, and sputum PAP stains read by leading cytopathologists who are participating in the study as medical partners.
Biomoda’s non-invasive diagnostic is based on a patented porphyrin application originally developed at Los Alamos National Laboratory that preferentially binds to cancerous or aberrant cells extracted from lung sputum samples and causes them to fluoresce red under ultraviolet light.
=================================================================
Biomoda Approved To Begin Screening Veterans For Lung Cancer
03.05.2009 — 8:00 am: Albuquerque, NM (March 5, 2009) – Biomoda, Inc. (OTC Bulletin Board: 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 lead 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.
News 
Market Data 
Discover 
