CytoDyn Treats First Patient with Leronlimab in Phase 2 Trial for GvHD under Modified Trial Protocol
Download as PDFMarch 04, 2020 6:00am EST
VANCOUVER, Washington, March 04, 2020 (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, announced today the treatment of the first patient in its Phase 2 clinical trial for graft-versus-host disease (GvHD) under the modified trial protocol.
The modified protocol now includes reduced intensity conditioning (RIC) patients and an open-label design under which all enrollees receive leronlimab. The modified protocol also provides for a 50% increase in the dose of leronlimab to more closely mimic preclinical dosing. The next review of data by the independent data monitoring committee (iDMC) will occur following enrollment of 10 patients under the amended protocol after each patient has been dosed for 30 days.
Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn, added, “GvHD is a life-threatening complication following bone marrow transplantation in patients with leukemia who have compromised immune systems due to treatment with aggressive cancer therapies. We selected GvHD as one of our immunology indications for leronlimab, as it targets and masks the CCR5 receptor on T cells. This receptor on T cells is an important mediator of inflammatory diseases including GvHD, especially in organ damage that is the most frequent cause of death in these patients.” Dr. Pourhassan concluded that, “Based upon the compelling results in our preclinical studies, we are optimistic about the opportunities for leronlimab to provide a therapy for transplant patients to mitigate GvHD.”
The Company’s preclinical study by Denis R. Burger, Ph.D., CytoDyn’s former Chief Science Officer, and Daniel Lindner, M.D., Ph.D. of the Department of Translational Hematology and Oncology Research, The Cleveland Clinic, was published online in the peer-reviewed journal Biology of Blood and Marrow Transplantation.
The Company previously reported that the U.S. Food and Drug Administration (FDA) granted orphan drug designation to leronlimab (PRO 140) for the prevention of GvHD. Orphan drug designation is granted to development-stage drugs that have shown promise in addressing serious medical needs for patients living with rare conditions. This designation provides CytoDyn with various incentives and benefits including seven years of U.S. market exclusivity for leronlimab (PRO 140) in GvHD, subject to FDA approval for use in this indication.
About Graft-versus-Host Disease (GvHD)
Graft-versus-host disease is a risk when patients receive the transplant of bone marrow stem cells donated from another person. GvHD occurs when the donor’s immune cells attack the patient’s normal cells. GvHD can be acute or chronic. Its severity depends on the differences in tissue type between patient and donor. The older the patient, the more frequent and serious the reaction may be. Acute GvHD can occur soon after the transplanted cells begin to appear in the recipient and can range from mild, moderate or severe, and be life-threatening if its effects are not controlled. Certain approved drugs exist that can help prevent or lessen GvHD. However, GvHD does not always respond to these treatments, and it can still result in fatal outcomes. Furthermore, many deaths related to GvHD occur because of infections that develop in patients whose immune systems are suppressed by such drugs.
Download as PDFMarch 04, 2020 6:00am EST
VANCOUVER, Washington, March 04, 2020 (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, announced today the treatment of the first patient in its Phase 2 clinical trial for graft-versus-host disease (GvHD) under the modified trial protocol. The modified protocol now includes reduced intensity conditioning (RIC) patients and an open-label design under which all enrollees receive leronlimab. The modified protocol also provides for a 50% increase in the dose of leronlimab to more closely mimic preclinical dosing. The next review of data by the independent data monitoring committee (iDMC) will occur following enrollment of 10 patients under the amended protocol after each patient has been dosed for 30 days.
Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn, added, “GvHD is a life-threatening complication following bone marrow transplantation in patients with leukemia who have compromised immune systems due to treatment with aggressive cancer therapies. We selected GvHD as one of our immunology indications for leronlimab, as it targets and masks the CCR5 receptor on T cells. This receptor on T cells is an important mediator of inflammatory diseases including GvHD, especially in organ damage that is the most frequent cause of death in these patients.” Dr. Pourhassan concluded that, “Based upon the compelling results in our preclinical studies, we are optimistic about the opportunities for leronlimab to provide a therapy for transplant patients to mitigate GvHD.”
The Company’s preclinical study by Denis R. Burger, Ph.D., CytoDyn’s former Chief Science Officer, and Daniel Lindner, M.D., Ph.D. of the Department of Translational Hematology and Oncology Research, The Cleveland Clinic, was published online in the peer-reviewed journal Biology of Blood and Marrow Transplantation.
The Company previously reported that the U.S. Food and Drug Administration (FDA) granted orphan drug designation to leronlimab (PRO 140) for the prevention of GvHD. Orphan drug designation is granted to development-stage drugs that have shown promise in addressing serious medical needs for patients living with rare conditions. This designation provides CytoDyn with various incentives and benefits including seven years of U.S. market exclusivity for leronlimab (PRO 140) in GvHD, subject to FDA approval for use in this indication.
About Graft-versus-Host Disease (GvHD)
Graft-versus-host disease is a risk when patients receive the transplant of bone marrow stem cells donated from another person. GvHD occurs when the donor’s immune cells attack the patient’s normal cells. GvHD can be acute or chronic. Its severity depends on the differences in tissue type between patient and donor. The older the patient, the more frequent and serious the reaction may be. Acute GvHD can occur soon after the transplanted cells begin to appear in the recipient and can range from mild, moderate or severe, and be life-threatening if its effects are not controlled. Certain approved drugs exist that can help prevent or lessen GvHD. However, GvHD does not always respond to these treatments, and it can still result in fatal outcomes. Furthermore, many deaths related to GvHD occur because of infections that develop in patients whose immune systems are suppressed by such drugs.
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