FDA Authorizes Seattle-based AVM Biotechnology to Proceed with Clinical Trials in COVID-19

Sep 16, 2020 | Blog, COVID-19, Dexamethasone, Investor Watch, News

FDA Authorizes Seattle-based AVM Biotechnology to Proceed with Clinical Trials in COVID-19

Seattle-based AVM Biotechnology has received FDA permission to proceed with clinical trials to evaluate its proprietary drug AVM0703 in the treatment of Acute Respiratory Distress Syndrome (ARDS) mediated by COVID-19 or Influenza patients. This is AVM’s second “safe to proceed” clinical trial authorization from the FDA within the past six months and demonstrates the broad potential of AVM’s lead drug. The previously approved study will evaluate AVM0703 in refractory/relapsed Non-Hodgkin’s Lymphoma patients. This second study consists of two different ARDS patient populations: one with COVID-19-mediated moderate to severe ARDS and the other with Influenza-mediated severe ARDS. 

Will Vaccines be Sufficient for All?

While vaccines may play a part in thwarting COVID-19, it is entirely possible that COVID-19 infection will still occur in a significant number of people. Even with influenza vaccines and antiviral drugs, a minimum of 17,000 Influenza patients develop ARDS in the USA each year. Therefore, therapies such as AVM0703 will most likely play a critical and continuing role in the future treatment of these patients.

“Quickly harnessing the body’s own immune system to produce its own Natural Killer and cytotoxic T-cells and its own dendritic cells is appealing on many levels in treating seriously ill patients. Doing so has potentially broad applications in other diseases, including cancers.” Janet R. Rea, AVM Biotechnology COO.

Challenges with Dexamethasone

TrialSite reported on the breakthrough during University of Oxford’s RECOVERY trial leading to the establishment of dexamethasone as a standard of care for certain hospitalized COVID-19 patients. Although generic formulations of dexamethasone are available, and daily low dosing has become a standard of care for moderately to severely ill COVID-19 patients, generic dexamethasone cannot be used at the high doses necessary to activate Natural Killer T (NKT), cytotoxic T and dendritic  cells, and to stimulate monocyte ablation and reduce neutrophils. The excipients in these generic formulations exceed safe levels at the required doses needed to activate these immune cells. Importantly, one single dose of AVM0703 triggers this critical immune system activation.

What is AVM0703?

AVM0703 is a novel and proprietary formulation of high concentration of dexamethasone. In addition to its recognized immunomodulatory properties, an acute high or suprapharmacologic dose of AVM0703 mobilizes highly active Natural Killer T- (NKT) and cytotoxic T- cells and dendritic cells. Within 6 hours of a single administration, there is evidence that AVM0703 “kick-starts” additional NKT cell activation. These cells have robust activity against very aggressive difficult-to-treat cancer models; this is directly relevant to COVID-19- and Influenza-mediated ARDS because NKT cells are programmed to eliminate abnormal cells, whether cancer or virus-infected.

Rapid elimination of infected monocytes in COVID-19 patients could reduce ICU stays and decrease long-term lung damage. NKT mobilization could also provide long-term T-cell immunity. Due to its striking immunomodulatory properties, AVM0703 may have therapeutic effects in a variety of blood cancers, solid tumors, and infectious diseases such as COVID-19 and Influenza. Because NKT cells eliminate virus-infected cells independent of the strain or type of virus, this could provide immediately available therapy for future pandemics from any virus.

The Sponsor

AVM Biotechnology is led by Dr. Theresa Deisher, a biotech veteran with a productive history including 47 patents and three discoveries in clinical trials. Dr. Deisher presented on the TrialSite Podcast recently. Company 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 including well-respected leaders in the areas of cancer and immunology. The company has received two SBIR grants, has filed for five worldwide Methods of Use patent families, has a worldwide Composition of Matter patent pending, and is committed to developing products that improve outcomes without additional suffering. They believe side effects from treatments should never be worse than the diseases themselves. This approval to begin an additional trial utilizing AVM0703 to treat ARDS patients is an exciting further step in support of that mission.

Call to Action:  For more information, please contact Jena Dalpez jdalpez@avmbiotech.com

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