GENOMED, INC. (Pink Sheet: GMED)

Editors Note: 

The recent progress toward mapping the human genome presents staggering medical possibilities.  As reported by Reuters on CNN (Click Here), the four-day conference recently held in Shanghai on the human genome highlighted the applications once the map is completed in 2003. Our profile today addresses the crux of human mortality -- the diseases that end our lives. 

As much as we would like to ignore it, diseases are a threat to all of us and the reality remains that for many of us, they will end our lives and almost certainly the lives of someone we hold dear.  But as we strive for longevity and the ability to avoid these death traps, technology has risen to levels that our grandparents couldn't have imagined, and that our parents only saw in sci-fi movies.

Today, we're mapping genes, peering into the architecture of our architecture.  In that process, we're endeavoring to find ways to defeat and avoid the aforementioned diseases with unprecedented scientific weaponry.

The future is indeed bright, very bright!

Our Featured Company, GenoMed (Pink Sheets: GMED), (GMED has filed a 10-SB in preparation for listing on the Over The Counter Bulletin Board), identifies genes for the purpose of enabling drug makers to create disease- fighting drugs that are custom built for each patient or groups of patients who share certain genetic traits, thereby increasing effectiveness.  GMED will sell this information to drug manufacturers and enjoy a licensing fee. 
 

To put this in brief biological perspective: Each cell nucleus holds  46 chromosomes in 23 pairs containing at least 35,000 genes.  This set of genes, the human genome, contains all the instructions for creating a human being. GenoMed estimates that perhaps 50 different genes contribute to each of approximately 200 common diseases, so there may be as many as 10,000 genes which cause common diseases. To date, the entire pharmaceutical industry has developed drugs against only 500 genes.

GenoMed’s screen of the human genome is expected to result in the identification of novel therapeutic targets for common, complex human diseases and  could help pharmaceutical companies develop new, highly specific drugs and find new uses and indications for existing therapies. 

GENOMED is in the business of identifying genes and commercializing the knowledge so that drugs may be specifically created to fight a disease. There are regulatory sequences within each gene that may accelerate or restrict production of enzymes causing a disease. The GENOMED method will lead to new prescription drugs that target the underlying cause of a disease and will allow drugs to be designed for certain people or groups of people who share the same genes. When GENOMED sells this genetic information to a pharmaceutical company, GMED receives licensing fees and that increases the company's residual cash-flow.

First, it is important to understand exactly what GMED is doing to determine why this Company could be so important to science and the practice of medicine.

GMED is studying genes to determine which genes are associated with which diseases.  It has acquired the fastest and most cost-effective genotyping system to affect these studies. 

Gene-based diagnostic tests: Millions of people die each year from disease and thousands more die from negative responses to drugs. GenoMed's diagnostics identify the genes that cause disease in order to potentially attack disease before symptoms ever become visible and to determine which drugs should be prescribed to a person based on his or her unique genetic makeup. 

Once the disease genes have been identified, GMED will list the genes onto the Company's proprietary Health Chip™.  GMED’s Health Chip will then be licensed or sold to hospitals, clinics, healthcare companies, disease management companies and pharmaceutical companies to screen patients against disease.  In the short-term future, GenoMed expects to have a partial distribution channel in place for the Health Chip through agreements with medical clinics such as La Clinica in St. Louis.

An example of the benefit would be: Your child visits the family doctor for a routine check-up where the doctor draws a blood specimen from your child.  The Physician will then screen your child's genes (which are contained within the blood specimen) against the genes contained on GMED’s Health Chip. This simple procedure will be able to determine whether your child is predisposed to any of the serious diseases contained within the Health Chip.

If your child is predisposed to any disease, which means that your child does have genes that are disease associated, then the physician can begin to treat those genes at an early age to either eliminate the disease association or delay the onset of the disease.

The way diseases are treated today is by diagnosing the disease when symptoms appear.  GMED believes that this is absolutely backwards.  Trying to treat disease when symptoms appear has been likened to building a dam to block the Mississippi River at the Gulf of Mexico.  It's virtually impossible.  Diagnosing disease before symptoms appear allows Doctors to build dams at the streamlets that flow into the Mississippi River. Serious diseases have to be diagnosed at the streamlets to avoid potentially fatal complications.

GenoMed has developed treatments that delay and, if taken early enough, even prevent kidney disease.  GMED has more than 3,000 patient years of data to support these treatments, and has agreed to license these treatments. 

GMED’s existing treatments have the potential to save the healthcare industry hundreds of millions of dollars by eliminating or delaying the need for dialysis.

And according to Dr. William Chignoli, M.D., founder of La Clinica in St. Louis, GenoMed’s drug regimen appears to delay and, if taken early enough, even prevent the complications of diabetes and hypertension. "I believe that GenoMed’s patient outcomes data are superior to anything in the medical literature to date.  The need for such a treatment is especially great in this patient population.  Almost half of the patients have diabetes, and there is little money available for surgery or hospitalization for these patients.  The best approach is to keep them healthy and GenoMed’s treatment is helping to accomplish this." (please note: Dr. Chignoli is a diabetic and is currently undergoing GenoMed’s treatments)

GenoMed recently acquired the first available SNP Stream Ultra High Throughput genotyping system. This system provides GMED with the ability to screen and score human genotypes faster and more cost efficiently than virtually every competitor in the genomics sector.  This means that GMED now has the ability to isolate and research genes to determine whether or not they are disease associated.

Analysts and experts have stated that the “Genomics revolution will rival the Industrial Revolution.”

GMED is on the cutting-edge of disease gene research and is developing treatments to fight the most common and serious diseases.  GMED’s research is centered in an area of the human genome that has been virtually unstudied, until now.

Based on its study of the ACE gene, GMED developed a treatment that delays kidney failure in Type 2 diabetes.  The disease was reversed altogether when patients were treated early in the course of the disease, before their serum creatinine, a standard measurement of kidney function, reached 2 milligrams per deciliter.

GMED recently finalized an Agreement with the American Diabetes Association to utilize the ADA’s collection of diabetes specimens.  This alliance provides GMED with access to the largest collection of diabetic specimens in the world, The G.E.N.N.I.D. collection.

GMED recently finalized an Agreement with BioCollections Worldwide, Inc. to collect samples from patients with a variety of common diseases. The collection of DNA specimens represents fifty-two (52) common diseases, including high blood pressure, heart attacks, diabetes and its complications, and common forms of cancer, such as prostate, breast, lung, and colon.

GMED is currently working to finalize additional license agreements during the next few months with revenues from the agreements beginning in September. 

GMED has also filed patent applications to protect its intellectual properties specific to the reformulation of two (2) drugs that are important to the Company's treatments.  This means that pharmaceutical companies would have to pay GMED to create a higher milligram (mg) tablet than exists today.

GMED’s expectations over the next 90 days:

· Its treatments to be published in at least 1 medical journal
· To sign a licensing agreement with a healthcare organization for the administration of GMED’s existing treatments
· A strategic alliance to be signed providing GenoMed with the computing power for its data analysis of genes

Other development stage genomics companies such as DNAprint genomics, Cytogenix and GeneLink trade at market caps up to $30 million dollars. GMED is currently trading at a $3 million dollar market cap.  Established genomics companies such as Celera Genomics, Applied BioSystems, Human Genome Sciences and Millennium Pharmaceuticals all trade at market caps well over a BILLION dollars.  This means that GenoMed is trading at less than one-fifth the valuation of other similar development stage genomics companies.

Like the science of genomic medicine, GenoMed takes a targeted and efficient approach to developing new  treatments, better using existing therapies and creating gene-based tests for known diseases. Our clinical experience has helped us to identify a class of single nucleotide polymorphisms (SNPs) that we believe has strong associations with several common diseases. Our clinical perspective, combined with proprietary, inexpensive, ultra-high throughput genotyping, gives us the ability to target disease causing genes accurately and quickly. 

In addition, GMED has dedicated a significantly higher percentage of resources directly to research compared to the industry average. GMED's ability to move much more quickly than larger, more bureaucratic corporations maximizes its intellectual property produced per dollar spent. 

GMED has a solid business model, has the experience, and is well positioned to capture market share within the genomics sector.  GMED’s approach to disease gene discovery and the treatment of common serious diseases should garner attention from the major players within the Biotech industry and the world of finance.  As long as GMED is categorizing disease genes through mass genotyping, then it is increasing its inventory of intellectual properties. 

GenoMed was inspired by Dr. David Moskowitz's research on the angiotensis I-converting enzyme (ACE) during the mid 1990s. His lab discovered that ACE was a "master" disease gene. ACE was found to be associated with about approximately 40 common, serious diseases such as type 2 diabetes, cancer, and even psychiatric disease. Moskowitz, a nephrologist, treated 1,000 of his own patients based on his knowledge of the potential of targeting the ACE. His early efforts produced dramatic results -- the rate of progression of kidney disease due to high blood pressure was reduced by an average of 400% in both African American and Caucasian male patients. Through this new treatment, patients that were expected to reach dialysis in 4 years were delayed by an average of 16 years in reaching end-stage kidney disease. Patient outcomes for kidney failure due to type 2 diabetes, atherosclerotic peripheral vascular disease, and emphysema (COPD) were equally exciting. In February 2001 Moskowitz founded GenoMed with the help of industry veterans Jerry White, Richard Kranitz and Peter Brooks. 

From the May 10, 2002 print edition

                 GenoMed Focuses On ACE Inhibitors; Seeks Partners

                    Margie Manning 

GenoMed Inc., a startup biotech company that focuses on identifying genes associated with diseases and finding drug treatments for them, expects to begin posting revenue by September through partnerships with doctors, clinics and a health management firm. 

The partnerships would be based on new uses and doses for ACE inhibitors, drugs traditionally used to treat people with high blood pressure and heart disease.

Dr. David Moskowitz, GenoMed's chairman and chief scientific officer, said his research has shown ACE inhibitors also can be used to prolong the onset of some types of diabetes, cancer and psychiatric disease -- a total of 40 common diseases associated with aging. 

"ACE inhibition can be accurately described as the fountain of youth which Ponce de Leon pursued in Florida," Moskowitz wrote in a provisional patent for the new ACE inhibitor treatment methods. 

GenoMed plans to collect fees from health-care providers and patients who sign up to use the patented treatment method, said Jerry White, president and chief executive. He's also negotiating with an outcomes management firm to track the health of the patients involved. 

He declined to identify the potential partners or how much revenue the partnerships could produce for GenoMed. 

GenoMed posted no revenue and had a net loss of $368,869 in 2001, according to an April 4 filing with the Securities and Exchange Commission. The company was based in Florida until it purchased Moskowitz's Genomic Medicine LLC in November and agreed to invest $1 million in Genomic Medicine over the next year. 

The quickest way for GenoMed to turn the profit corner is to find new uses for existing drugs, based on its genetics research, White said. That's where Moskowitz's work comes in. 

Moskowitz, a kidney specialist, began working with ACE inhibitors when he was at Saint Louis University and the St. Louis Veterans Administration Medical Center, and found the drug delayed the progression of end-stage kidney disease. 

Since then, Moskowitz said he's found the gene that's targeted by ACE inhibitors also is frequently found in patients with other diseases. 

Dr. Arthur Labovitz, director of cardiology at Saint Louis University Health Sciences Center, said that while there appeared to be a number of potential uses for ACE inhibitors, "In order to use ACE inhibitors or any new medication for that matter for new indications, you need to do clinical trials and demonstrate to the FDA and to your peers that it's effective in that manner." 

Moskowitz said he plans to show doctors how effective his new treatment methods are through publication of a series of papers, beginning in August, in medical journals. 

"We're hoping, instead of running afoul of the FDA, that we'll use the power of the government and its interest in enforcing patents to make sure we get paid license fees," he said. 

  Genomic Medicine

                              Although more than 99% of human DNA sequences are the same across the population, variations in DNA sequences can have a major impact on  the progression and treatment of disease. Single nucleotide polymorphisms (SNPs) are DNA sequence variations that occur when a single nucleotide (A, T, C or G) in the genome sequence is altered. It is widely believed that SNPs predispose people to disease or influence their response to drugs, which make the study of SNPs of tremendous value for developing pharmaceutical products or medical diagnostics. SNPs are also evolutionarily stable --not changing much from generation to generation -making them easy to follow in population studies. 

   Technology and Approach

                               GenoMed's two primary initiatives are the Disease GeneNet™ and HealthChip™. The Disease GeneNet is the set of single nucleotide polymorphisms (SNPs) GenoMed uses to locate disease genes. The Disease  GeneNet is currently made up of 1,620 SNPs; GenoMed is working to expand the net to include up to as many as 100,000 SNPs. The probability of identifying disease genes increases proportionally with the number of SNPs in the Disease GeneNet. Once the disease genes are identified, disease-associated SNPs are placed onto a single DNA chip, the HealthChip, for clinical diagnostic testing. 

   Targeted Diseases

                               Currently collections are underway or scheduled for the following diseases: 

                                    Type 2 diabetes (also called "adult-onset diabetes," or NIDDM) 
                                    End-stage kidney disease due to type 2 diabetes 
                                    Heart Attack due to Type 2 Diabetes 
                                    Stroke due to Type 2 Diabetes
                                    High blood pressure 
                                    End-stage kidney disease due to high blood pressure 
                                    Heart Attack due to high blood pressure 
                                    Stroke due to high blood pressure 
                                    Breast cancer 
                                    Lung cancer 
                                    Prostate cancer 
                                    Colon cancer 

The Market

                               The medical industry is currently a one trillion dollar a year market and is expanding at a rapid pace. The recent completion of the Human Genome Project has changed the way we view the treatment of disease and signifies a revolution in the medical industry. 

                               Genomics is in its infancy and is already a multi-billion dollar industry worldwide. During the next decade, cutting-edge genomic companies will be the catalyst for extraordinary medical advances. The largest pharmaceutical companies in the world such as Bristol-Myers Squibb, Merck, Pfizer, and Johnson &  Johnson, to name only a few, have recognized the value of genomics, and understand that it will reshape the medical industry as we know it. 

The Opportunity

                               GenoMed is positioning itself to take advantage of the recent advances in genomics and information technology. The completion of the Human Genome Project and huge leaps in computing power have helped make possible the understanding of the 3 billion plus letters that make up our genetic code. This information that is being developed will assist in the production of drugs to treat various diseases and potentially eliminate these diseases altogether. The largest pharmaceutical companies in the world are eager to garner this information to better target their existing drugs and create new blockbuster drugs. It will be the responsibility of cutting-edge companies like GenoMed to farm the data that will make these advances possible. 

Looking at the valuations of GMED’s competition, many consider GMED to be undervalued.  If GMED were to only trade at a market valuation based on the most conservative comparisons, then it should trade at 20¢ per share or more than six times where it is today.  It is simply UNDERVALUED and OVERLOOKED. This is about to CHANGE.

GMED will be getting a lot of attention from the investment community during the next few months.  GMED’s treatments should be published soon by well known health journals; HealthCare organizations and Disease Management firms will be contracted to get GMED’s treatments into the clinics ( with a strategic alliance to be inked) and GMED will announce discoveries of never before identified disease associated genes.

GMED is a penny stock with valuable existing intellectual properties and MULTI-MILLION dollar potential within the Biotech and genomics sector today. 

GMED has an iron clad business model, has the experience, and is well positioned to capture market share within the genomics sector.  GMED’s approach to disease gene discovery and the treatment of common serious diseases has positioned it to garner attention from the major players within the Biotech industry and the world of finance. 

***  Recent News About GMED AND DNAPrint  ***

Sarasota, FL - March 6, 2002 - DNAPrint genomics, Inc. (OTCBB: DNAP) announced today that it has entered into a commercial and equity-based agreement with GenoMed, Inc. (Pink Sheets: "GMED") that has upgraded DNAPrint’s facility for the provision of genotyping services. The agreement is expected to provide DNAPrint annual revenues in excess of $1.6 million. 

                               Under the agreement, GenoMed has purchased a beta version of an Orchid Ultra-High Throughput (UHT) genotyping system and has integrated it with DNAPrint’s existing Orchid 25K SNPstream platform. With the integration, DNAPrint becomes GenoMed’s exclusive genotyping contractor. The integration establishes the first commercially licensed UHT facility operating Orchid technology in the world, and provides DNAPrint a faster and less expensive platform for its own research and product development. In addition, the new platform establishes DNAPrint as one of only a handful of companies in the world capable of scoring more than 100,000 genotypes per eight-hour shift. 

                               The initial term of the contract is two years, but it automatically renews every two years thereafter in order to sensitively determine the price per genotype that GenoMed pays DNAPrint. The contract calls for DNAPrint to produce over 4 million genotypes for GenoMed in the first year at a cost of approximately $1.6 million. The larger scope of the agreement establishes DNAPrint and GenoMed as long-term participants in a joint commercial genotyping venture. 
 

David W. Moskowitz, MD - Chairman and Chief Medical Officer

                               Dr. Moskowitz majored in Chemistry (summa cum laude) at Harvard College, Biochemistry (first class honors) at Merton College, Oxford, and received an MD (cum laude) from the Harvard-MIT Division in Health Sciences and Technology (Harvard Medical School). He trained for 7 years in Internal Medicine and Nephrology at Washington University School of Medicine in St. Louis before spending 11 years on the faculty of St. Louis University School of Medicine. From 1994 to 1997, Dr. Moskowitz experienced first hand the clinical effectiveness of knowing a disease-associated gene (the angiotensin converting enzyme, or ACE, gene). Dr. Moskowitz is a pioneer in the field of medical genomics, and has been recognized for his groundbreaking treatment of diseases associated with the angiotensin I-converting enzyme, such as chronic renal failure due to hypertension or type II diabetes.
 

* * * CONTACT * * *

GENOMED
4560 Clayton Ave.
St. Louis, Missouri 63110 

Craig Hall
941.366.6677

Genomed Disclaimer
GenoMed and FloridaFunds.com are the repsonsible source for the information in this profile. This profile contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including those statements pertaining to the beneficial nature of GenoMed’s business model, intellectual properties, agreements, and other matters relating to Genomed’s business.  The words or phrases “would be,” “will allow,” “intends to,” “will likely result,” “are expected to,” “will continue,” “is anticipated,” “estimate,” “project,” or similar expressions are intended to identify “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995.   Actual results could differ materially from those projected in the forward looking statements as a result of  a number of risks and uncertainties.  Among other things, the following will impact our business: competition from existing or new competitors our business; whether we have sufficient funding to conduct our operations; and our research and development which is subject to economic, regulatory, governmental, and technological factors.  Statements made herein are as of the date of this press release and should not be relied upon as of any subsequent date.  Unless otherwise required by applicable law, we do not undertake, and specifically disclaims any obligation, to update any forward-looking statements to reflect occurrences, developments, unanticipated events or circumstances after the date of such statement.

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