CytoDyn Files IND and Protocol for Phase 2 Clinica
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Posted On: 03/08/2020 5:53:28 PM
CytoDyn Files IND and Protocol for Phase 2 Clinical Trial for Treatment of Patients with Coronavirus with Leronlimab (PRO 140)
VANCOUVER, Washington, March 08, 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 that the Company has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) to conduct a Phase 2 clinical trial with leronlimab (PRO 140) as a therapy for patients who experience respiratory complications as a result of contracting the coronavirus disease 2019 (COVID-19).
Bruce Patterson M.D., CEO of IncellDX and advisor to CytoDyn explains: “Leronlimab inhibits migration of Tregs, which can inhibit the innate immune response against pathogens, into areas of inflammation. Most importantly, the migration of macrophages and the release of inflammatory cytokines including TNF and IL-6 (cytokine storm) is what causes the profound damage in the lungs in some patients. Leronlimab binding to CCR5 changes the macrophages migration and cytokine production. Taken together, these activities may reduce the morbidity and mortality in moderate to severe cases of COVID-19. IncellDx has developed a suite of diagnostics to monitor these effects of leronlimab on the immune system in these critical patients.”
“Coronavirus deaths are linked to patients’ immune systems that have an inflammatory response to the virus causing Acute Respiratory Distress Syndrome (ARDS). With ARDS, the entire lung is affected, unlike pneumonia where often only part of the lung is affected,” said Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn. “Our scientists believe that our data in cancer patients indicated that leronlimab’s role in blocking Tregs and macrophages demonstrates that leronlimab modulates the inflammatory response to more effectively provide effector function. With more than 840 patients treated with leronlimab in our clinical trials, we believe leronlimab could reduce the inflammation which contributes to ARDS, thereby potentially reducing morbidity and mortality rates in coronavirus patients. If we can show a similar response in our current Phase 2 trial, then leronlimab could have a powerful impact on improving the prognosis for coronavirus patients. With leronlimab’s Fast Track designation from the FDA for the treatment of HIV and mTNBC (triple-negative breast cancer), we are expediting the initiation of this trial to address the rapid spread of this disease and are eager to test this proof of concept in clinical trials as a potential treatment for coronavirus,” added Dr. Pourhassan.
The following is a brief summary of excerpts from the Company’s Phase 2 clinical trial protocol:
Indication for Use: Leronlimab is indicated for treatment of adult patients with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection.
Objective: The purpose of this study is to assess the safety and efficacy of leronlimab administered as weekly subcutaneous injection in subjects with coronavirus 2019 infection.
Primary Outcome (Endpoint) Measure: Clinical Improvement based on change in total symptom score (for fever, myalgia, dyspnea and cough)
Note: The total score per patient ranges from 0 to 12 points. Each symptom is graded from 0 to 3 [0=none, 1=mild, 2=moderate, and 3=severe].
Trial Design: This is a Phase 2, single arm, open-label, multicenter study to evaluate the safety and efficacy of leronlimab (PRO 140) in patients with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection. Leronlimab (PRO 140) will be administered subcutaneously as weekly dose of 700 mg.
The study will have three phases: Screening Period, Treatment Period, and Follow-Up Period.
Treatment Period: 4 weeks ± allowed windows.
Inclusion Criteria:
Male or female adult ≥ 18 years of age at time of enrollment.
Laboratory confirmation of coronavirus 2019 infection by polymerase chain reaction (PCR) or other commercial or public health assay from any diagnostic sampling source.
Subjects with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
Understands and agrees to comply with planned study procedures.
Women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study (acceptable methods will be determined by the site).
VANCOUVER, Washington, March 08, 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 that the Company has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) to conduct a Phase 2 clinical trial with leronlimab (PRO 140) as a therapy for patients who experience respiratory complications as a result of contracting the coronavirus disease 2019 (COVID-19). Bruce Patterson M.D., CEO of IncellDX and advisor to CytoDyn explains: “Leronlimab inhibits migration of Tregs, which can inhibit the innate immune response against pathogens, into areas of inflammation. Most importantly, the migration of macrophages and the release of inflammatory cytokines including TNF and IL-6 (cytokine storm) is what causes the profound damage in the lungs in some patients. Leronlimab binding to CCR5 changes the macrophages migration and cytokine production. Taken together, these activities may reduce the morbidity and mortality in moderate to severe cases of COVID-19. IncellDx has developed a suite of diagnostics to monitor these effects of leronlimab on the immune system in these critical patients.”
“Coronavirus deaths are linked to patients’ immune systems that have an inflammatory response to the virus causing Acute Respiratory Distress Syndrome (ARDS). With ARDS, the entire lung is affected, unlike pneumonia where often only part of the lung is affected,” said Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn. “Our scientists believe that our data in cancer patients indicated that leronlimab’s role in blocking Tregs and macrophages demonstrates that leronlimab modulates the inflammatory response to more effectively provide effector function. With more than 840 patients treated with leronlimab in our clinical trials, we believe leronlimab could reduce the inflammation which contributes to ARDS, thereby potentially reducing morbidity and mortality rates in coronavirus patients. If we can show a similar response in our current Phase 2 trial, then leronlimab could have a powerful impact on improving the prognosis for coronavirus patients. With leronlimab’s Fast Track designation from the FDA for the treatment of HIV and mTNBC (triple-negative breast cancer), we are expediting the initiation of this trial to address the rapid spread of this disease and are eager to test this proof of concept in clinical trials as a potential treatment for coronavirus,” added Dr. Pourhassan.
The following is a brief summary of excerpts from the Company’s Phase 2 clinical trial protocol:
Indication for Use: Leronlimab is indicated for treatment of adult patients with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection.
Objective: The purpose of this study is to assess the safety and efficacy of leronlimab administered as weekly subcutaneous injection in subjects with coronavirus 2019 infection.
Primary Outcome (Endpoint) Measure: Clinical Improvement based on change in total symptom score (for fever, myalgia, dyspnea and cough)
Note: The total score per patient ranges from 0 to 12 points. Each symptom is graded from 0 to 3 [0=none, 1=mild, 2=moderate, and 3=severe].
Trial Design: This is a Phase 2, single arm, open-label, multicenter study to evaluate the safety and efficacy of leronlimab (PRO 140) in patients with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection. Leronlimab (PRO 140) will be administered subcutaneously as weekly dose of 700 mg.
The study will have three phases: Screening Period, Treatment Period, and Follow-Up Period.
Treatment Period: 4 weeks ± allowed windows.
Inclusion Criteria:
Male or female adult ≥ 18 years of age at time of enrollment.
Laboratory confirmation of coronavirus 2019 infection by polymerase chain reaction (PCR) or other commercial or public health assay from any diagnostic sampling source.
Subjects with mild-to-moderate symptoms of respiratory illness caused by coronavirus 2019 infection
Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator.
Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
Understands and agrees to comply with planned study procedures.
Women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study (acceptable methods will be determined by the site).
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