No Aborted Fetal Material in AVM Biotechnology's COVID-19 Treatment Drug
SEATTLE, Oct. 14, 2020 /PRNewswire/ -- There has been much criticism of the President who has openly decried the use of aborted fetal material in scientific research, for allowing Regeneron's antibody product and remdesivir to be used in his COVID-19 treatment. Many are going so far as to call him a hypocrite since his administration banned the use of newly aborted fetal material in government funded research.
AVM Biotechnology's lead investigational drug, AVM0703, for moderate to severe COVID-19 Acute Respiratory Distress Syndrome (ARDS) does not utilize aborted fetal or other ethically objectionable material in either the discovery, development, manufacture or testing of the drug.
There are several COVID-19 vaccines and treatments in development which are manufactured or tested utilizing aborted fetal material. People are seeking a treatment option with a positive safety profile that has no connection to fetal materials.
Seattle's AVM Biotechnology is developing such a treatment. AVM0703 has FDA approval for clinical trials in both relapsed/refractory (R/R) Non-Hodgkin's Lymphoma and ARDS caused by either COVID-19 or Influenza.
For those who cannot participate in one of these trials, AVM Biotechnology offers an Expanded Access ("Compassionate Use") Program for AVM0703 https://avmbiotech.com/compassionate-use/ as well as template documents and guidance for treating physicians to facilitate the application process. AVM0703 can be considered for a single-patient, Physician-sponsored IND for Emergency/Expanded Use.
AVM0703 is a patent-pending, highly-concentrated form of injectable dexamethasone that, when given at suprapharmacologic doses, induces a rapid and striking immune response mediated by supercharged Natural Killer T cells. NKTs are programmed by nature to eliminate abnormal cells, whether cancer or virus-infected. NKTs also have the potential to trigger both antibody and T cell long-term immunity.
In addition to Regeneron and remdesivir, President Trump received NIH recommended daily low dose dexamethasone for his COVID-19 disease, highlighting the usefulness of dexamethasone, which has been widely used since its initial approval in 1958 in treating many chronic conditions. Although multiple generic versions of dexamethasone are available in the US, generic dexamethasone cannot be used at the suprapharmacologic doses necessary to induce the striking immune response of AVM0703, because excipients such as benzyl alcohol and/or parabens in the generic products then exceed safe levels.
AVM Biotechnology is led by its founder Dr. Theresa Deisher, a biotech veteran with a productive history including 47 patents and four discoveries in clinical trials. Its COO, Janet R. Rea, has a proven track record working with federal regulators and successfully bringing drugs to market. The Executive Board is comprised of world leaders in the areas of respiratory illness, regulatory affairs, and vaccine development, and AVM is guided by a global Advisory Board that includes well-respected leaders in the areas of cancer and immunology. The company has received two SBIR grants and holds eight worldwide patent families that cover the use and formulation of AVM0703 as well as three other AVM Biotechnology programs. The AVM team is committed to developing products that improve outcomes without additional suffering, because they believe side effects from treatments should never be worse than the diseases themselves.
Most importantly, AVM Biotechnology does not use any aborted fetal material in the discovery, development, or manufacture of any products. This commitment is a founding principle of the organization.
For additional information about the Compassionate Use Program, visit https://avmbiotech.com/compassionate-use/ or contact Jena Dalpez [email protected].
This contains certain statements that constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements do not relate strictly to historical or current facts and they may be accompanied by words such as "could," "would," "may," "potentially," "suggest," "believes," "expects," "should," and similar words or expressions. These forward-looking statements reflect our current views as of the date this is published, and are subject to risks, uncertainties, assumptions, changes in circumstances, and other factors; drug development and commercialization are highly risky and early clinical results in animals or humans may not reflect the full results from later stage or larger scale clinical trials. These forward-looking statements are subject to risks and uncertainties that could cause our actual results, performance, and expectations to differ materially from those expressed or implied by these statements, including statements about: future and ongoing drug development and timing; the applications of drugs to specific diseases; the potential for ongoing preclinical or clinical trial results; FDA or other regulatory findings and approvals; potential market opportunities; and the occurrence of future events or circumstances. There are risks and uncertainties involving and not limited to our ability to progress in our research and development efforts, complete clinical testing, achieve our expected results, commercialize our products, avoid infringement of patients, trademarks and other proprietary rights of third parties, protect products from competition, navigate the political environment, maintain sufficient capital and funding, avoid problems with our manufacturing processes, maintain our operations, and obtain regulatory approval to sell and market the drugs in the United States and elsewhere. The reader should not place any undue reliance on such forward-looking statements. We have no obligation to release publicly the results of any revisions to any of our forward-looking statements to reflect events or circumstances after the date these statements are made or to reflect the occurrence of unanticipated events, except as may be required by law.
Media Contact: Jena Dalpez, [email protected], 206-906-9922
SOURCE AVM Biotechnology, LLC
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