Southern California Patients Treated with Leronlim
Post# of 155329
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Posted On: 04/13/2020 7:09:38 AM
Southern California Patients Treated with Leronlimab for COVID-19 under Emergency IND: 4 Patients with Moderate Indications Removed from Oxygen; 3 Patients Discharged from Hospital; 1 Patient Scheduled for Discharge Today; 1 Patient with Severe Indications Discharged, for Total of 5 Patients Discharged
April 13, 2020 6:15am EDT
More than 25 EINDs approved by FDA for leronlimab use in COVID-19 patients
Phase 2 trial - As of last week, 12 patients enrolled from 2 sites; 3 more sites to initiate enrollment this week, for a total of 5 sites
Phase 2b/3 trial - First hospital cleared to enroll patients beginning today
VANCOUVER, Washington, April 13, 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 a comprehensive update and overview of the therapeutic indications from over 30 COVID-19 patients recently treated with leronlimab in over 4 hospitals and clinics throughout the country. More than 25 hospitals, to date, have requested participation in the Company’s trials.
Patient enrollment in the Company’s two clinical trials and Emergency Investigational New Drug (EIND) is as follows:
More than 25 patients have been administered leronlimab under EINDs authorized by the U.S. Food and Drug Administration (FDA).
Rate of response in mild-to-moderate patients under EIND has been very promising with the first five patients treated being removed from oxygen.
As of last week, 12 patients have been treated in the Phase 2 trial for mild-to-moderate COVID-19 indications and, because it is a double-blinded, placebo-controlled trial, results are not yet available.
First site cleared to enroll patients in Phase 2b/3 beginning today.
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn said, “We continue to coordinate around the clock with healthcare professionals across the country to deliver leronlimab to patients and we are in regular contact with the FDA to ensure they receive current patient data. We are planning to rapidly enroll 75 patients and report the results to the FDA as quickly as possible.”
April 13, 2020 6:15am EDT
More than 25 EINDs approved by FDA for leronlimab use in COVID-19 patients
Phase 2 trial - As of last week, 12 patients enrolled from 2 sites; 3 more sites to initiate enrollment this week, for a total of 5 sites
Phase 2b/3 trial - First hospital cleared to enroll patients beginning today
VANCOUVER, Washington, April 13, 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 a comprehensive update and overview of the therapeutic indications from over 30 COVID-19 patients recently treated with leronlimab in over 4 hospitals and clinics throughout the country. More than 25 hospitals, to date, have requested participation in the Company’s trials. Patient enrollment in the Company’s two clinical trials and Emergency Investigational New Drug (EIND) is as follows:
More than 25 patients have been administered leronlimab under EINDs authorized by the U.S. Food and Drug Administration (FDA).
Rate of response in mild-to-moderate patients under EIND has been very promising with the first five patients treated being removed from oxygen.
As of last week, 12 patients have been treated in the Phase 2 trial for mild-to-moderate COVID-19 indications and, because it is a double-blinded, placebo-controlled trial, results are not yet available.
First site cleared to enroll patients in Phase 2b/3 beginning today.
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn said, “We continue to coordinate around the clock with healthcare professionals across the country to deliver leronlimab to patients and we are in regular contact with the FDA to ensure they receive current patient data. We are planning to rapidly enroll 75 patients and report the results to the FDA as quickly as possible.”
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