IMPORTANT CORRECTION OF INVESTIGATIONAL DRUG INFORMATION

On February 11, 2022, CytoDyn, Inc. received a Warning Letter from the U.S. Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion in which FDA asserted that statements made in a video created a misleading impression regarding the safety and efficacy of leronlimab.  Leronlimab is an investigational drug that has not been approved (or authorized) by the U.S. FDA for the treatment of COVID-19 or for any indication.  For more information, click here to access a Dear Healthcare Provider (DHCP) Letter: View Here.

COVID-19

About Coronavirus Disease 2019

SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal.

Leronlimab in COVID-19

The “cytokine storm” is believed to play an integral role in the development of acute respiratory distress syndrome (ARDS) in those affected by COVID-19. Chemokines and chemokine receptors play a critical role in the recruitment, activation, and coordination of leukocytes in the pathophysiology of lung inflammation. The acute respiratory distress syndrome (ARDS) of COVID-19 results from the accumulation of neutrophils within the pulmonary circulation and alveolar spaces. Leronlimab (PRO 140) may inhibit the migration of Tregs into areas of inflammation, which can inhibit the innate immune response against pathogens and, most importantly, may prevent the migration of macrophages and release of pro-inflammatory cytokines in lungs.

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