CytoDyn Announces Findings of Statistically Signif
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Posted On: 02/06/2025 8:32:02 AM
CytoDyn Announces Findings of Statistically Significant Fibrosis Reversal Across Studies with SMC Laboratories
https://www.cytodyn.com/newsroom/press-releas...ignificant
VANCOUVER, Washington, Feb. 06, 2025 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"
, a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today positive results from its preclinical studies with SMC Laboratories (“SMC”).
The three studies demonstrated statistically significant reversal of liver fibrosis with leronlimab monotherapy (compared to an isotype IgG4 control arm with p-values across all 3 studies < 0.01). The first two studies, completed in late 2024, evaluated leronlimab in the STAM™ model of metabolic dysfunction associated steatohepatitis (MASH) with fibrosis in mice who received a single dose of Streptozocin at birth and were then fed a high fat diet from weeks four to twelve. The third study, concluded in January 2025, evaluated reversal of liver fibrosis in mice who received carbon tetrachloride, a liver fibrosis-inducing agent, from birth to sacrifice at day 35.
“ The management of patients with advanced liver fibrosis due to a variety of etiologies is an area of enormous unmet need in the field of hepatology. The results of these three preclinical studies support both the biologic activity and potential clinical benefit of leronlimab’s ability to bind to CCR5 receptors on hepatic stellate cells, leading to a reversal of established liver fibrosis,” said Melissa Palmer, MD FAASLD, the Company’s Lead Consultant in Hepatology.
Dr. Jacob Lalezari, CEO of CytoDyn, added, “We are very encouraged by these initial findings, which add to the growing body of evidence that leronlimab’s core mechanism of action, binding to CCR5 receptors on cells, could translate into a variety of meaningful clinical benefits for patients across a number of medical conditions . As the Company continues to prioritize its oncology objectives for 2025, we look forward to establishing the right partnership to further the clinical development pathway for leronlimab in the treatment of fibrosis of the liver and potentially other organs, such as the lungs and heart .”
CytoDyn is currently in discussions with several third parties regarding next steps in an effort to expand on these promising findings . The Company intends to explore a number of potential synergies and partnership opportunities in the coming months as it furthers its clinical development pipeline, including opportunities that might explore the potential widespread applications for leronlimab as a treatment path for fibrosis in other organs.
https://www.cytodyn.com/newsroom/press-releas...ignificant
VANCOUVER, Washington, Feb. 06, 2025 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"
, a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today positive results from its preclinical studies with SMC Laboratories (“SMC”). The three studies demonstrated statistically significant reversal of liver fibrosis with leronlimab monotherapy (compared to an isotype IgG4 control arm with p-values across all 3 studies < 0.01). The first two studies, completed in late 2024, evaluated leronlimab in the STAM™ model of metabolic dysfunction associated steatohepatitis (MASH) with fibrosis in mice who received a single dose of Streptozocin at birth and were then fed a high fat diet from weeks four to twelve. The third study, concluded in January 2025, evaluated reversal of liver fibrosis in mice who received carbon tetrachloride, a liver fibrosis-inducing agent, from birth to sacrifice at day 35.
“ The management of patients with advanced liver fibrosis due to a variety of etiologies is an area of enormous unmet need in the field of hepatology. The results of these three preclinical studies support both the biologic activity and potential clinical benefit of leronlimab’s ability to bind to CCR5 receptors on hepatic stellate cells, leading to a reversal of established liver fibrosis,” said Melissa Palmer, MD FAASLD, the Company’s Lead Consultant in Hepatology.
Dr. Jacob Lalezari, CEO of CytoDyn, added, “We are very encouraged by these initial findings, which add to the growing body of evidence that leronlimab’s core mechanism of action, binding to CCR5 receptors on cells, could translate into a variety of meaningful clinical benefits for patients across a number of medical conditions . As the Company continues to prioritize its oncology objectives for 2025, we look forward to establishing the right partnership to further the clinical development pathway for leronlimab in the treatment of fibrosis of the liver and potentially other organs, such as the lungs and heart .”
CytoDyn is currently in discussions with several third parties regarding next steps in an effort to expand on these promising findings . The Company intends to explore a number of potential synergies and partnership opportunities in the coming months as it furthers its clinical development pipeline, including opportunities that might explore the potential widespread applications for leronlimab as a treatment path for fibrosis in other organs.
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