Good morning. Some more good news !!!
CytoDyn Reports Strong Positive Preclinical Data to Demonstrate Potential of Leronlimab in Treating Nonalcoholic Fatty Liver Disease (NAFLD) in Humanized Mouse Model
New preclinical data using a humanized mouse model confirms and expands on the potential use of leronlimab in treating this inflammatory syndrome, a common precursor to NASH VANCOUVER, Washington, Nov. 21, 2019 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, today announced strong positive preclinical data highlighting the potential of leronlimab in treating nonalcoholic fatty liver disease (NAFLD), a common precursor to nonalcoholic steatohepatitis (NASH).
These data, along with previous findings showing that leronlimab inhibits liver fibrosis, demonstrates the potential of leronlimab to control both the early and late stages of NASH. The study, in which immunodeficient, NOD-scid gamma (NSG) mice were fed a high fat, NASH-inducing diet, transplanted with human stem cells to repopulate the deficient immune system, and treated with leronlimab, found that that leronlimab effectively inhibited fatty liver development, an early indication of NASH. CytoDyn previously published data showing that leronlimab completely blocked Xeno-GvHD in these humanized mice. Daniel Lindner, M.D., Ph.D. of the Cleveland Clinic, who conducted the studies, stated: “Our results showed that leronlimab effectively inhibited fatty liver development, the hallmark of early stages of NASH.”
“We are very excited to see more evidence showing that leronlimab may play a critical role in slowing or reversing disease progression in NAFLD and potentially NASH patients," said Nader Pourhassan, Ph.D., CytoDyn President and Chief Executive Officer. “It is important to note that in people living with HIV, the occurrence of NAFLD is higher than in the general population, affecting 30 to 65 percent of the HIV population1. Medications that HIV patients take as part of their regimen may cause fatty liver development and have other hepatoxic effects. As we approach 1,000 patients involved in our HIV trials, we have not observed the hepatoxicity that has been evident in other CCR5 antagonists and HIV medications. We see leronlimab as potentially anchoring a patient’s HIV treatment regimen, or as a monotherapy HIV drug, designed to protect the liver, maintain and regain liver health, and protect healthy cells from HIV entry.”
There are currently no U.S. Food and Drug Administration (FDA) approved treatments for NASH and it is expected to be the number one cause of liver transplant by 20202. About 30 to 40 percent of adults in the U.S. are living with NAFLD, and 3 to 12 percent of adults in the U.S. are living with NASH3.
“The significant unmet medical need and the lack of approved treatment options for NASH has led to a healthy interest in licensing therapeutics, even those in the preclinical phase,” said Brendan Rae, Ph.D., J.D., CytoDyn Senior Vice President of Business Development. “Based on recent activity in the space, combined with leronlimab’s efficacy and human safety profile in the model, we expect there to be a significant interest from industry stakeholders in the development of leronlimab for the treatment of NASH.” CytoDyn has an FDA approved Phase 2 protocol for a 60-patient, multi-center, randomized, double-blind, placebocontrolled study of the safety and efficacy of leronlimab (PRO 140) in adult patients with NASH.
CytoDyn Reports Strong Positive Preclinical Data to Demonstrate Potential of Leronlimab in Treating Nonalcoholic Fatty Liver Disease (NAFLD) in Humanized Mouse Model
New preclinical data using a humanized mouse model confirms and expands on the potential use of leronlimab in treating this inflammatory syndrome, a common precursor to NASH VANCOUVER, Washington, Nov. 21, 2019 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, today announced strong positive preclinical data highlighting the potential of leronlimab in treating nonalcoholic fatty liver disease (NAFLD), a common precursor to nonalcoholic steatohepatitis (NASH).
These data, along with previous findings showing that leronlimab inhibits liver fibrosis, demonstrates the potential of leronlimab to control both the early and late stages of NASH. The study, in which immunodeficient, NOD-scid gamma (NSG) mice were fed a high fat, NASH-inducing diet, transplanted with human stem cells to repopulate the deficient immune system, and treated with leronlimab, found that that leronlimab effectively inhibited fatty liver development, an early indication of NASH. CytoDyn previously published data showing that leronlimab completely blocked Xeno-GvHD in these humanized mice. Daniel Lindner, M.D., Ph.D. of the Cleveland Clinic, who conducted the studies, stated: “Our results showed that leronlimab effectively inhibited fatty liver development, the hallmark of early stages of NASH.”
“We are very excited to see more evidence showing that leronlimab may play a critical role in slowing or reversing disease progression in NAFLD and potentially NASH patients," said Nader Pourhassan, Ph.D., CytoDyn President and Chief Executive Officer. “It is important to note that in people living with HIV, the occurrence of NAFLD is higher than in the general population, affecting 30 to 65 percent of the HIV population1. Medications that HIV patients take as part of their regimen may cause fatty liver development and have other hepatoxic effects. As we approach 1,000 patients involved in our HIV trials, we have not observed the hepatoxicity that has been evident in other CCR5 antagonists and HIV medications. We see leronlimab as potentially anchoring a patient’s HIV treatment regimen, or as a monotherapy HIV drug, designed to protect the liver, maintain and regain liver health, and protect healthy cells from HIV entry.”
There are currently no U.S. Food and Drug Administration (FDA) approved treatments for NASH and it is expected to be the number one cause of liver transplant by 20202. About 30 to 40 percent of adults in the U.S. are living with NAFLD, and 3 to 12 percent of adults in the U.S. are living with NASH3.
“The significant unmet medical need and the lack of approved treatment options for NASH has led to a healthy interest in licensing therapeutics, even those in the preclinical phase,” said Brendan Rae, Ph.D., J.D., CytoDyn Senior Vice President of Business Development. “Based on recent activity in the space, combined with leronlimab’s efficacy and human safety profile in the model, we expect there to be a significant interest from industry stakeholders in the development of leronlimab for the treatment of NASH.” CytoDyn has an FDA approved Phase 2 protocol for a 60-patient, multi-center, randomized, double-blind, placebocontrolled study of the safety and efficacy of leronlimab (PRO 140) in adult patients with NASH.
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