CytoDyn to Present New Data from Study of Investigational HIV Therapy Leronlimab (PRO 140), a Long-Acting, Single-Agent Maintenance Therapy at CROI 2019
https://www.cytodyn.com/media/press-releases/...tigational
VANCOUVER, Washington, Feb. 27, 2019 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), a late stage biotechnology company developing a novel humanized CCR5 monoclonal antibody for multiple therapeutic indications, today announced that data from its study of leronlimab (PRO 140) is scheduled to be presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2019) on March 7, 2019. Leronlimab is a once weekly, subcutaneous injection that blocks HIV-1 from entering and infecting human cells by binding to the CCR5 receptor with high affinity. The abstract and poster will be available at www.cytodyn.com at approximately the same time as the poster presentation.
The annual Conference on Retroviruses and Opportunistic Infections (CROI) brings together top basic, translational, and clinical researchers from around the world to share the latest studies, important developments, and best research methods in the ongoing battle against HIV/AIDS and related infectious diseases. CROI 2019 will be held from March 4 to March 7, 2019, at the Washington State Convention Center in Seattle, Washington.
CytoDyn’s Poster at CROI 2019:
Poster # 486: PRO 140 (leronlimab) SC: Long-Acting, Single-Agent Maintenance Therapy for HIV-1 Infection
Presenters: Drs. Kush Dhody and Nader Pourhassan
Date: Thursday, March 7, 2:30pm-4:00pm, Poster Hall – 4EF
“CytoDyn’s commitment to providing groundbreaking therapeutic advances for those in need has never been stronger. We remain highly encouraged by the continued clinical and regulatory progress to bring the next generation HIV treatment to patients,” stated Dr. Nader Pourhassan, President, CEO and Director of CytoDyn.
Dr. Pourhassan concluded, “CytoDyn is in the process of completing a Biologics License Application (BLA) with the FDA for leronlimab (PRO 140) as a combination therapy with HAART for HIV-infected patients. Then, subject to approval by the FDA as a combination therapy, CytoDyn plans to file for a label expansion for leronlimab (PRO 140) as a monotherapy, providing the company can achieve positive results from a proposed Phase 3 pivotal trial with leronlimab (PRO 140) as a monotherapy.”
About Leronlimab (PRO 140)
Leronlimab (PRO 140) is an investigational humanized IgG4 monoclonal antibody that blocks CCR5, a cellular receptor that plays multiple roles with implications in HIV infection, tumor metastasis, and immune signaling.
In the setting of HIV/AIDS, leronlimab belongs to a new class of therapeutics called viral-entry inhibitors; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. At the same time, leronlimab does not appear to interfere with the normal function of CCR5 in mediating immune responses. Leronlimab has been the subject of seven clinical trials, each of which demonstrated that leronlimab can significantly reduce or control HIV viral load in human test subjects. Leronlimab has been designated a “fast track” product by the FDA. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.
In the setting of cancer, research has shown that CCR5 likely plays a central role in tumor invasion and metastasis and that increased CCR5 expression is an indicator of disease status in several cancers. Moreover, research has shown that drugs that block CCR5 can block tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. CytoDyn is conducting additional research with leronlimab in the cancer setting and plans to initiate Phase 2 human clinical trials when appropriate.
The CCR5 receptor also appears to play a central role in modulating immune cell trafficking to sites of inflammation and may be crucial for the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to further support the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD and that blocking this receptor from recognizing certain immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of graft-versus-host disease (GvHD).
https://www.cytodyn.com/media/press-releases/...tigational
VANCOUVER, Washington, Feb. 27, 2019 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), a late stage biotechnology company developing a novel humanized CCR5 monoclonal antibody for multiple therapeutic indications, today announced that data from its study of leronlimab (PRO 140) is scheduled to be presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2019) on March 7, 2019. Leronlimab is a once weekly, subcutaneous injection that blocks HIV-1 from entering and infecting human cells by binding to the CCR5 receptor with high affinity. The abstract and poster will be available at www.cytodyn.com at approximately the same time as the poster presentation.
The annual Conference on Retroviruses and Opportunistic Infections (CROI) brings together top basic, translational, and clinical researchers from around the world to share the latest studies, important developments, and best research methods in the ongoing battle against HIV/AIDS and related infectious diseases. CROI 2019 will be held from March 4 to March 7, 2019, at the Washington State Convention Center in Seattle, Washington.
CytoDyn’s Poster at CROI 2019:
Poster # 486: PRO 140 (leronlimab) SC: Long-Acting, Single-Agent Maintenance Therapy for HIV-1 Infection
Presenters: Drs. Kush Dhody and Nader Pourhassan
Date: Thursday, March 7, 2:30pm-4:00pm, Poster Hall – 4EF
“CytoDyn’s commitment to providing groundbreaking therapeutic advances for those in need has never been stronger. We remain highly encouraged by the continued clinical and regulatory progress to bring the next generation HIV treatment to patients,” stated Dr. Nader Pourhassan, President, CEO and Director of CytoDyn.
Dr. Pourhassan concluded, “CytoDyn is in the process of completing a Biologics License Application (BLA) with the FDA for leronlimab (PRO 140) as a combination therapy with HAART for HIV-infected patients. Then, subject to approval by the FDA as a combination therapy, CytoDyn plans to file for a label expansion for leronlimab (PRO 140) as a monotherapy, providing the company can achieve positive results from a proposed Phase 3 pivotal trial with leronlimab (PRO 140) as a monotherapy.”
About Leronlimab (PRO 140)
Leronlimab (PRO 140) is an investigational humanized IgG4 monoclonal antibody that blocks CCR5, a cellular receptor that plays multiple roles with implications in HIV infection, tumor metastasis, and immune signaling.
In the setting of HIV/AIDS, leronlimab belongs to a new class of therapeutics called viral-entry inhibitors; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. At the same time, leronlimab does not appear to interfere with the normal function of CCR5 in mediating immune responses. Leronlimab has been the subject of seven clinical trials, each of which demonstrated that leronlimab can significantly reduce or control HIV viral load in human test subjects. Leronlimab has been designated a “fast track” product by the FDA. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.
In the setting of cancer, research has shown that CCR5 likely plays a central role in tumor invasion and metastasis and that increased CCR5 expression is an indicator of disease status in several cancers. Moreover, research has shown that drugs that block CCR5 can block tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. CytoDyn is conducting additional research with leronlimab in the cancer setting and plans to initiate Phase 2 human clinical trials when appropriate.
The CCR5 receptor also appears to play a central role in modulating immune cell trafficking to sites of inflammation and may be crucial for the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to further support the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD and that blocking this receptor from recognizing certain immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of graft-versus-host disease (GvHD).
