Here is another very complete report made by Brad about BioModa.
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To: BIGFRED (2771 )
From: Elio Madama Wednesday, Feb 3 1999 3:53AM ET
Reply # of 2944
To: Brad (1127 )
From: Brad Tuesday, Jun 23 1998 2:32AM ET
Reply # of 2773
BIOMODA EARLY CANCER DETECTION & TREATMENT:
(ADOT owns 27% of BIOMODA, INC.)
Please Note!
(This information has been compiled by me, an independent investor, and is presented to be as accurate as possible according to what information I have been able to obtain from public and private sources. This should NOT be assumed exact, but is presented as a starting point for research purposes.)
This is why I believe Biomoda, Inc is such an attractive part of the ADOT picture. I spent many hours in discussion with Biomoda. Biomoda is a private company, but they had no problem with me sharing this information.
It was an incredible education for me. It might take a little time to read, but hopefully will be of help in understanding what the Biomoda ownership represents as an asset to ADOT.
This is what I learned...
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Background -
BIOMODA Inc. is a bio tech company (not publicly traded) that holds a world-wide exclusive license in perpetuity from the University of California to a NEW patented molecular marker/binder technology for the very early detection of lung cancer AND an integrated treatment for lung cancer. Early detection is as much as 6 years earlier than
other methods used.
Biomoda Patent Info:
Method using 5,10,15,20-tetrakis(4-carboxyphenyl)porphine for treating cancers of the lung. patents.ibm.com
Method of using 5,10,15,20-tetrakis(carboxyphenyl)porphine for detecting cancers of the lung. patents.ibm.com
ADOT is positioned to benefit from this because of ADOT's 27% ownership interest in Biomoda and ADOT is also capable of producing the equipment used in the commercial application of Biomoda's patented medical technology.
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Overview of The Technology and Its Progress -
The Biomoda process is the result of many years of study and research by some of the most highly respected cytopathologists in the world. Including, in fact, the world's leading cytopathologist, Dr Geno Saccomanno.
(Please see Dr Saccomanno's credentials later in this report)
The technology utilizes an exclusively licensed synthetic TCPP (a photoreactive porphyrin compound) that is rapidly absorbed by cancer cells, particularly lung cancer cells. One of the important characteristics of TCPP is that it fluoresces red when exposed
to ultraviolet light. Current methods of cytological detection depend on human visualization and subjective interpretation or pattern recognition to locate abnormal cells.
This technology was originally developed through research done by the US Government at Los Alamos & Sandia Laboratories Medical Isotopes Program and St Mary's Hospital & Medical Center in Colorado. It involved such well known researchers as Dr. Jim Mulshine of the National Cancer Institute and the late Dr. John Frost of Johns Hopkins
University in addition to Dr Saccomanno.
Biomoda originally tested 3,500 samples at St Mary's Hospital & Medical Center and at Johns Hopkins University. The findings of those tests were considered extremely favorable, but more scientific studies were required to establish the efficacy of the early cancer detection process.
So a 15 patient "single blind study" done between St. Mary's Hopital & Medical Center and Los Alamos National Labs was conducted. Five (5) of the 15 were "control" samples (non-cancerous) and ten (10) were cancerous. However, when the samples were tested using the Biomoda process, only 4 were found non-cancerous and 11 were found cancerous. Indeed, the test found cancer in one of the samples that had not been detected previously. And the diagnosis was correct.
Biomoda is currently doing a 60 patient (2 samples each) "double blind study" at a cytopathology lab in Arizona. Those 120 slides will be the subject of another "blind study" at the University of Pennsylvania Medical School for independent confirmation by a group of Board Certified Pathologists. Those results are expected to be presented for review to various organizations including the American Cancer Society, the American Lung Assn, and the American Pathology Assn. Biomoda expects to have this completed by around September 1, 1998.
Additional larger "double blind studies" using up to 300 patient samples are expected to be conducted starting in September to further define the remarkable capabilities of this unique process.
The patents for this technology have been issued in the USA, Australia, and Russia. Patent applications are pending in 17 other countries.
Wide scale application of Biomoda's early detection technology requires standardization and automation of readings. The patented technology ADOT uses can provide the image analysis automation necessary for large-scale screening in cytopathology labs across the
country and around the world.
Click Here to see a demonstration of how this technology works:
biomoda.com
Biomoda technology covers Early Detection and Treatment separately.
Early Detection of Cancer... The cytology reagents are regulated by FDA as chemical solution stains under 21CFR864.1850. Devices in this category are both Class 1 devices and explicitly exempted by statute from 510k premarket notification procedures.
Biomoda adapts its reagents and testing methodologies to diagnostic devices already approved by the FDA and in the marketplace. This exemption applies to the early detection process only, so it is possible for this process to be marketed very soon.
Treatment... The treatment process will require FDA approval so it will have to follow the standard course for that approval. Biomoda has already been approached by several major pharmaceutical companies (including Schering AG/Berlex Laboratories and others) interested in Biomoda's process. One of these prospective major partners will likely play a large role in the application of the treatment technology.
The early detection cancer test can be expected to improve 5-year survival rates from 13% up to 46%. With the advent of Biomoda's new lung cancer treatment, this diagnostic/treatment program can be expected to increase these survival rates even further.
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The Numbers -
The early cancer detection test can be as easy as brushing your teeth.
It can detect lung cancer 6 years earlier than other tests currently used.
Other types of cancers can also be detected using this technology.
Annual screening can benefit 77 million Americans over age 45 who are at risk.
Sample can be done at home in minutes and mailed in (or delivered) for screening.
The test would cost about $10 at the store and about $20 for screening fees.
Thousands of Diagnostic Centers across the country and around the world could process the samples quickly and easily using Biomoda's specifically designed technology.
Multiple samples would be processed by computerized photo-imaging and the "positive" cases would then be reviewed by a pathologist for the appropriate next steps for the patient.
For consumers, the test is easy, simple and the results can prove life-saving.
People at risk (or just curious about their health) can get results quickly and efficiently.
The test could be used by insurance companies to determine risks among applicants.
Biomoda is also working with companies to provide this technology in Europe, China and Latin America, as well as in the USA.
In China, lung cancer has become a national epidemic where over 900,000 people a year die from lung cancer. China has over 300 million smokers and the Chinese Government recognizes the severity of the problem.
For the past 2 years, Biomoda has been working with the Shanghai Center of New Drug Development (an entity of the Chinese Government and the city of Shanghai), to develop a program utilizing this early detection and treatment technology. The Shanghai Center has signed a Letter of Intent with Biomoda and wants Biomoda to deliver a "turn-key" operation that they can use to fight this problem. Biomoda is now working on a plan to address this opportunity.
Biomoda hopes to have its first "sale" of Early Cancer Detection Kits by the end of September and begin receiving revenues during the 4th Quarter of this year.
For Lung Cancer Screening - At $10 per test, the potential annual market just for all smokers over age 45 in the USA alone, is $770 Million! For all people in the USA over the age of 40, it's estimated at $1.4 Billion !!
For Lung Cancer Treatment - Biomoda estimates the present market for lung cancer therapies is about $450 Million and Biomoda expects to retain a significant share of that market through possible joint ventures with a major pharmaceutical partner.
PAP smear tests could also be replaced using this technology. PAP smear tests have long been considered inaccurate and create many problems from false "positive" and false "negative" readings. If PAP smear tests were applying for FDA approval today, they would not be approved. Biomoda's technology can be far more effective. This market is considered to be extremely large.
Biomoda expects to be actively in the market in the 4th Quarter of 1998 (per CEO of Biomoda).
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RESEARCH CREDENTIALS
Biomoda has been contacted by BERLEX LABORATORIES on behalf of its parent company, SCHERING AG. Schering AG is a German-based pharmaceutical and medical technology company headquartered in Berlin. Schering AG, with over $3.8 Billion ($U.S.) in annual revenues and offices worldwide, is a recognized leader in biotechnology research and the use of contrast media in the diagnosis and treatment of a
variety of diseases. Here are the web sites for Schering AG and Berlex Laboratories.
schering.de
betaseron.com
Biomoda Inc also happens to be featured as one of the main Lung Cancer Information Links at the Roy Castle Lung Cancer Foundation in Great Britain. This foundation has built the world's first lung cancer research centre in Liverpool, UK.
roycastle.org (click on "links")
SCIENTIFIC ADVISORY BOARD Includes Noted Leader in Lung Cancer Research:
Geno Saccomanno, M.D., Ph.D. of St. Mary's Hospital and Medical Center in Colorado.
Dr Saccomanno is considered "the world's best pulmonary "cyto-pathologist."
emphysemafoundation.org
Dr Saccomanno is one of the most highly respected lung cancer researchers in the world.
He has been actively involved in lung cancer research for over 40 years and is most noted for his lung cancer research involving uranium miners throughout Colorado. He works closely with the US Dept of Justice and the US Dept of Energy.
Dr. Saccomanno is associated with the St. Mary's Hospital School of Cytotechnology and the St. Mary's Cancer Research Institute, has been involved in lung cancer research since 1957. He authored the textbook, Diagnostic Pulmonary Cytology, and has been the recipient of many scientific honors for his pioneering work in lung cancer research and
early detection.
Medical cytopathology awards given in countless countries around the world are named in honor of Dr Saccomanno for his work in this area.
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Here are a few more sites that reflect his work.
aacr.org
aacr.org
niehs.nih.gov
columbia.net
uchsc.edu
eml.doe.gov
ehpnet1.niehs.nih.gov
biomoda.com
junkscience.com
seas.gwu.edu.
med.nyu.edu
In addition to Dr Saccomanno, Biomoda's other noted researchers include:
Dr. L. Edward Ellinwood, a distinguished pharmacologist and physician associated with St.Mary's Hospital and Los Alamos National Laboratory, has been involved with research on the early detection and treatment of lung cancer in uranium miners. He has published extensively in this field as well as on the effects of radiation on body tissue and organs. He is the one of the contributors to the patents which the Company has licensed.
Dr. Buck Rhodes, has over thirty years of expertise in the field of radiopharmaceutical research. He has published or co-published more than 160 scientific papers, seven textbooks, eight audio visual programs and has been issued 12 medical product-related patents with 12 patents pending. Most recently, Dr. Rhodes served as president of
RhoMed Incorporated. He is an honorary diplomat to the the American Board of Science in Nuclear Medicine and holds a PhD in radiological science from the John Hopkins University.
Here are the bios on the Scientific Advisory Board for Biomoda:
biomoda.com
Biomoda CEO -
Mr. Ari Ma'ayan, age 55, has been a Director of the Company since 1990. Mr. Ma'ayan is a seasoned biotechnology executive with broad experience in strategic planning, product and process development, manufacturing, quality control, and regulatory compliance issues. He will be directly involved in technology and product transfer.
He has served as Vice President for RhoMed, Inc., ChemBioMed, Inc., and American BioDesign, Inc. He held senior staff positions at Biogen, Inc. and Genzyme Corp. He is a Clinical Assistant Professor of Pharmacy at the University of New Mexico. Mr. Ma'ayan's academic experience includes research and development assignments with Ben Gurion University, University of Texas, and the Hebrew University of Medicine.
He has been the recipient of honors from the Canadian Research Council, American Cancer Society, and a grant recipient of the National Institutes of Health. Mr. Ma'ayan holds a BSC from the Hebrew University of Jerusalem.
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The information above is MY understanding of the Biomoda program. I am not trained in the medical field and my opinions are strictly personal. I am presenting this information to the best of my knowledge, but I could be wrong. You should verify any and all information to your own satisfaction before making any investment decisions.
Best wishes,
Brad
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