WHY GMED - new credibility -GenoMed's Universal Approach to Viral Diseases, Including the Flu and SARS, to be Tested by NIAID
ST. LOUIS--(December 18, 2003)--GenoMed Inc. ("the Company" or "GenoMed") (National Quotation Bureau’s Pink Sheets Symbol GMED) announced today that it has entered into an agreement with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, to test the Company's compounds in tissue culture assays to evaluate potential activity against influenza (the flu), West Nile virus, and SARS. Preclinical testing by the NIAID does not constitute an endorsement by the NIAID of GenoMed’s clinical trial.
Prevailing dogma holds that people who die from viral diseases--especially the very young and the very old--are immunocompromised and lack the ability to fight back against the virus. But autopsy results show a very strong immune response. Except in obviously immunocompromised people taking steroids or chemotherapy, it's the host's initial immune response, not overgrowth of the virus, that kills the host. For bacterial disease like anthrax, it's the opposite: unchecked growth of the bacterium liquefies organs.
Respiratory viruses like influenza, Hantavirus, RSV, and SARS cause death due to an acute respiratory distress-like syndrome (ARDS). ARDS is caused by an overly exuberant innate immune response. The host's initial immune response--whether moderate or excessive--not viral overgrowth, appears to determine whether the host lives or dies.
For novel viruses like this year's flu virus, the SARS coronavirus, and West Nile virus, the body has no memory of having ever seen the virus, so it can't coat the virus with pre-existing antibodies or calm the rage of immune effector cells with soothing suppressor T cells. The whole point of vaccination is to have pre-existing antibodies and lymphocytes with "memory" for the virus present when the virus eventually infects the host. Vaccination creates suppressor T cells with specific memory for the virus as well as coating antibodies. Without a competent suppressor limb, the immune response can become unbalanced, leading to organ damage in the host.
GenoMed believes it has discovered a way to accomplish the equivalent of vaccination against all viruses, a kind of "universal vaccine" against most viral diseases. The method involves blocking angiotensin II, an approach already known to be extremely safe from its use in hundreds of millions of patients since 1978.
Angiotensin II is important in getting the innate immune response started, because angiotensin I-converting enzyme (ACE), the enzyme which produces angiotensin II, is expressed on macrophages and T cells when these cells get activated. All immune cells, including macrophages, T and B cells, and neutrophils, contain type 1 receptors for angiotensin II. Blocking angiotensin II production with a suitable ACE inhibitor at a suitable dose, or the action of angiotensin II at type 1 receptors with an angiotensin II receptor blocker (ARB), is therefore expected to tone down the host's initial immune response. This is equivalent to what a good vaccine does. GenoMed's approach should decrease mortality from most viral infections, and may even hasten recovery from the common cold.
The patient's blood pressure should be the guide as to whether an ACE inhibitor or an ARB is chosen.
Said Dr. David Moskowitz, GenoMed's Chief Medical Officer and CEO, "While the NIAID is testing efficacy of our approach in model systems, anyone in the world can test it for themselves. This is especially important for people getting sicker rather than recovering as fast as expected from the flu or SARS. The Internet now makes it possible for anybody to enroll in our free clinical trials at any time of day or night anywhere in the world, simply by going to our website and clicking on the relevant trial. Once they enter their email address so that we can follow up with them, they'll be able to download the 2 documents they'll need to show their physician in order to get started immediately on our trial. A family member could easily do this for a child getting worse with the flu, for example."
The drugs GenoMed uses are safe enough to allow for their preventive use, and are available in every corner drug store. Most physicians are already comfortable using them to treat high blood pressure. Angiotensin II receptor blockers at extremely low doses appear to be effective against overactivity of the immune system without lowering blood pressure at all.
To volunteer for one of GenoMed's free clinical trials, go to www.genomedics.com.
About GenoMed
GenoMed, Inc. is a Next Generation Disease Management(TM) whose mission is to improve patient outcomes by identifying the molecular pathways that cause disease. A St. Louis Business Journal article (http://www.stlouis.bizjournals.com/stlouis/stories/2002/05/13/story8.html) first reported that the company has applied for patents based on its finding that the ACE gene is associated with a large number of common diseases including virtually all autoimmune diseases.
For questions, please contact David W. Moskowitz MD, MA(Oxon.), FACP at 314-977-0110, FAX 314-977-0042, email: dwmoskowitz@genomedics.com, or visit GenoMed at www.genomedics.com.
This press release contains forward looking statements, including those statements pertaining to GenoMed, Inc.’s (the Company’s) treatments. The words or phrases "ought to,” “should,” "could," “may,” 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, including but not limited to: (a) whether GenoMed's approach will prove to be effective in cell culture or animal models of viral disease; (b) whether GenoMed's approach will prove to be effective in human cases of viral disease such as the flu and SARS; (c) whether GenoMed's server will hold up to international demand; (d) whether we will have sufficient financing to conduct our research and development; and (e) our research and development being subject to other 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 specifically disclaim any obligation to update any forward-looking statements to reflect occurrences, developments, unanticipated events or circumstances after the date of such statement.