https://www.cytodyn.com/newsroom/press-releas...and-london
CytoDyn Will Attempt to Duplicate Berlin and London Patients’ HIV Cure by Using Leronlimab During Bone Marrow Transplant for 5 HIV Patients Who also have Cancer
Download as PDFAugust 17, 2020 6:15am EDT
HIV monotherapy trials update: 215 patients completed almost one year of monotherapy. Only some were allowed to continue in extension arm; five patients reached almost 6 years. Twenty-five reached 2 to 4 years and 20 patients are 1 to 2 years
VANCOUVER, Washington, Aug. 17, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"
, a late-stage biotechnology company gives full update on all of its HIV programs.
HIV Cure
The HIV co-receptor CCR5 has proven to be a key molecule in mediating HIV remission. The only two individuals functionally cured of HIV, one from London and the other from Berlin, received allogeneic stem cell transplantations from CCR5-deficient donors. However, because it is extremely rare to find a stem cell donor who lacks CCR5 and meets stringent MHC matching criteria, such an approach is unfeasible to cure HIV on a larger scale. CytoDyn believes its CCR5 blocking antibody, leronlimab, could be used in the setting of allogeneic stem cell transplantation to functionally convert a stem cell graft from a wildtype CCR5 stem cell donor into one from a CCR5 deficient donor, and thereby functionally cure the recipient of HIV.
CytoDyn plans to test this theory in a pilot clinical trial of five HIV patients with cancer who require bone marrow transplantation. Leronlimab will be used during the peri-transplant period to mimic a CCR5 deficient donor in order to achieve HIV cure.
HIV PrEP
As presented at the AIDS 2020 Virtual Conference, a pre-clinical study in the macaque model of HIV sexual transmission demonstrated leronlimab can prevent infection by blocking HIV’s access to the CCR5 co-receptor. This protection is similar to that seen in individuals naturally CCR5 deficient and forms the rationale for use in HIV cure. CytoDyn believes leronlimab could be a once-a-month self-injectable, subcutaneous treatment for HIV PrEP and is in discussions with potential organizations to fund its next trial in HIV PrEP.
Monotherapy
Significantly, for the first time documented, of the 49 HIV patients who stopped their HIV medications and used leronlimab as a monotherapy, 25 have been in monotherapy trial for two to four years and five patients for nearly or over six years. Monotherapy was successful for some of these patients by switching from 350 mg to a higher dose of 525 mg or 700 mg. The number of participants in the extension groups was limited due to costs.
The Company will submit manuscripts for two publications in regards to its findings.
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, “We now have four paths forward for use of leronlimab in the HIV indication for different populations. The first path is a combination therapy where we successfully completed a Phase 3 trial with statistically significant p value for our primary endpoint. CytoDyn is awaiting a Type A meeting with the FDA for this treatment. Second is our monotherapy; we will discuss the potential approval path for label expansion at the time of our Type A meeting. Third is our PrEP study to examine the use of leronlimab for once-a-month self-injection for HIV prevention. Our fourth path is an HIV-Cure, where 5 patients will be put to test to duplicate the Berlin and London patients’ HIV functional cure.”
About Leronlimab (PRO 140)
CytoDyn Will Attempt to Duplicate Berlin and London Patients’ HIV Cure by Using Leronlimab During Bone Marrow Transplant for 5 HIV Patients Who also have Cancer
Download as PDFAugust 17, 2020 6:15am EDT
HIV monotherapy trials update: 215 patients completed almost one year of monotherapy. Only some were allowed to continue in extension arm; five patients reached almost 6 years. Twenty-five reached 2 to 4 years and 20 patients are 1 to 2 years
VANCOUVER, Washington, Aug. 17, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"
, a late-stage biotechnology company gives full update on all of its HIV programs. HIV Cure
The HIV co-receptor CCR5 has proven to be a key molecule in mediating HIV remission. The only two individuals functionally cured of HIV, one from London and the other from Berlin, received allogeneic stem cell transplantations from CCR5-deficient donors. However, because it is extremely rare to find a stem cell donor who lacks CCR5 and meets stringent MHC matching criteria, such an approach is unfeasible to cure HIV on a larger scale. CytoDyn believes its CCR5 blocking antibody, leronlimab, could be used in the setting of allogeneic stem cell transplantation to functionally convert a stem cell graft from a wildtype CCR5 stem cell donor into one from a CCR5 deficient donor, and thereby functionally cure the recipient of HIV.
CytoDyn plans to test this theory in a pilot clinical trial of five HIV patients with cancer who require bone marrow transplantation. Leronlimab will be used during the peri-transplant period to mimic a CCR5 deficient donor in order to achieve HIV cure.
HIV PrEP
As presented at the AIDS 2020 Virtual Conference, a pre-clinical study in the macaque model of HIV sexual transmission demonstrated leronlimab can prevent infection by blocking HIV’s access to the CCR5 co-receptor. This protection is similar to that seen in individuals naturally CCR5 deficient and forms the rationale for use in HIV cure. CytoDyn believes leronlimab could be a once-a-month self-injectable, subcutaneous treatment for HIV PrEP and is in discussions with potential organizations to fund its next trial in HIV PrEP.
Monotherapy
Significantly, for the first time documented, of the 49 HIV patients who stopped their HIV medications and used leronlimab as a monotherapy, 25 have been in monotherapy trial for two to four years and five patients for nearly or over six years. Monotherapy was successful for some of these patients by switching from 350 mg to a higher dose of 525 mg or 700 mg. The number of participants in the extension groups was limited due to costs.
The Company will submit manuscripts for two publications in regards to its findings.
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, “We now have four paths forward for use of leronlimab in the HIV indication for different populations. The first path is a combination therapy where we successfully completed a Phase 3 trial with statistically significant p value for our primary endpoint. CytoDyn is awaiting a Type A meeting with the FDA for this treatment. Second is our monotherapy; we will discuss the potential approval path for label expansion at the time of our Type A meeting. Third is our PrEP study to examine the use of leronlimab for once-a-month self-injection for HIV prevention. Our fourth path is an HIV-Cure, where 5 patients will be put to test to duplicate the Berlin and London patients’ HIV functional cure.”
About Leronlimab (PRO 140)
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