Zidovudine

CytoDyn and NIH of Mexico Complete Memorandum of Understanding to Conduct Small Covid-19 Phase 3 Trial for Severe and Critically Ill Patients

Retrieved on: 
Monday, June 29, 2020
Hepatotoxins, Medical specialties, HIV/AIDS, Retroviridae, Drugs, RTT, Management of HIV/AIDS, Zidovudine, HIV, PRO 140, CCR5 receptor antagonist

The NIH of Mexico is an organization that coordinates the main institutions of medical care and public research in the country.

Key Points: 
  • The NIH of Mexico is an organization that coordinates the main institutions of medical care and public research in the country.
  • This Phase 3 trial is similar to our Phase 3 trial protocol in the U.S., with the exception of the number of patients.
  • CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients.
  • CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients.

CytoDyn Initiates Phase 2 Clinical Trial With Leronlimab for Treatment of NASH

Retrieved on: 
Thursday, June 11, 2020
Health, Clinical research, Design of experiments, Hepatotoxins, Medical research, Medicine, Clinical trial, Pharmaceutical industry, Zidovudine, Randomized controlled trial, Management of HIV/AIDS, PRO 140

The Phase 2 trial is designed to test whether leronlimab may control the devastating liver fibrosis associated with NASH.

Key Points: 
  • The Phase 2 trial is designed to test whether leronlimab may control the devastating liver fibrosis associated with NASH.
  • CytoDyn has met its 75-patient enrollment target in its Phase 2 clinical trial for COVID-19, a randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. and enrollment continues in its Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population in several hospitals throughout the country.
  • CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients.
  • CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer.

CytoDyn Reached Its Enrollment Target for Phase 2 COVID-19 Trial for Mild to Moderate Indication – Primary End Point Announcement Is Next

Retrieved on: 
Thursday, June 11, 2020
Medical specialties, Health, Medicine, Hepatotoxins, Prevention of HIV/AIDS, Management of HIV/AIDS, Triple-negative breast cancer, Zidovudine, Graft-versus-host disease, Clinical trial, PRO 140, CCR5 receptor antagonist

Because there are more patients who have been screened for enrollment, final enrollment is expected to exceed 75.

Key Points: 
  • Because there are more patients who have been screened for enrollment, final enrollment is expected to exceed 75.
  • CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients.
  • CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients.
  • CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer.

Global Antiretroviral Therapy Market (NRTI, NNRTI, Protease Inhibitors & Integrase Inhibitors): Insights & Forecast with Potential Impact of COVID-19 (2020-2024)

Retrieved on: 
Saturday, May 23, 2020
Hepatotoxins, Prevention of HIV/AIDS, Management of HIV/AIDS, Integrase inhibitors, Drugs, RTT, Medical specialties, Reverse-transcriptase inhibitor, Chemical substances, Protease inhibitor, Zidovudine, Treatment as prevention

The global antiretroviral therapy market is also prone to certain challenges like increasing voluntary male circumcisions and huge cost of treatment.

Key Points: 
  • The global antiretroviral therapy market is also prone to certain challenges like increasing voluntary male circumcisions and huge cost of treatment.
  • The global antiretroviral therapy market by drug type can be segmented into the following: NRTI, NNRTI, protease inhibitors and integrase inhibitors.
  • The global antiretroviral therapy market by region can be segmented into the following regions: North America, Europe and Asia Pacific.
  • The report provides a comprehensive analysis of the global antiretroviral therapy market with potential impact of COVID-19.

CytoDyn to Prepare a Phase 3 Protocol to Submit to the FDA for a Three-Arm Comparative and Combination Trial of Leronlimab and Remdesivir

Retrieved on: 
Monday, May 18, 2020
Health, Hepatotoxins, Prevention of HIV/AIDS, Drugs, Medicine, Management of HIV/AIDS, Zidovudine, Clinical trial, PRO 140, CCR5 receptor antagonist

Leronlimab was administered to more than sixty patients with COVID-19 under emergency Investigational New Drug (eINDs) authorizations granted by the FDA.

Key Points: 
  • Leronlimab was administered to more than sixty patients with COVID-19 under emergency Investigational New Drug (eINDs) authorizations granted by the FDA.
  • CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients.
  • CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients.
  • CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer.

CytoDyn Completed Submission of All Remaining Parts of Biologics License Application (“BLA”) on May 11, 2020

Retrieved on: 
Wednesday, May 13, 2020
Health, Food and Drug Administration, Pharmaceuticals policy, Hepatotoxins, Prescription Drug User Fee Act, Articles, Zidovudine, Management of HIV/AIDS, Priority review

After the BLA submission is deemed completed, the FDA assigns a Prescription Drug User Fee Act (PDUFA) goal date.

Key Points: 
  • After the BLA submission is deemed completed, the FDA assigns a Prescription Drug User Fee Act (PDUFA) goal date.
  • The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases.
  • After the BLA submission is considered completed, the FDA will make a filing decision and set a PDUFA goal date.
  • CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients.

CytoDyn Clarifies Status of Biologics License Application

Retrieved on: 
Saturday, May 9, 2020
Drugs, Hepatotoxins, Medicine, Medical specialties, Management of HIV/AIDS, Prevention of HIV/AIDS, Zidovudine, PRO 140, CCR5 receptor antagonist

The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases.

Key Points: 
  • The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases.
  • CytoDyn is, therefore, conducting aPhase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.
  • CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients.
  • CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients.

Novant Health Initiates Phase 2b/3 Trial with CytoDyn’s Leronlimab for Severely and Critically Ill COVID-19 Patients

Retrieved on: 
Thursday, May 7, 2020
Hepatotoxins, Retroviridae, Medical specialties, Chemical substances, Prevention of HIV/AIDS, Management of HIV/AIDS, Zidovudine, HIV/AIDS, HIV

Leronlimab has been administered to 54 severely and critically ill COVID-19 patients thus far under Emergency Investigational New Drug (EINDs) authorizations granted by the U.S. Food and Drug Administration (FDA).

Key Points: 
  • Leronlimab has been administered to 54 severely and critically ill COVID-19 patients thus far under Emergency Investigational New Drug (EINDs) authorizations granted by the U.S. Food and Drug Administration (FDA).
  • Since initiating the leronlimab mild/moderate last month, Novant Health has screened nearly 400 patients for eligibility.
  • Expanding treatment options for our more critically ill patients is a vital step in our fight against COVID-19.
  • CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients.

CytoDyn Announces Vyrologix as Proprietary Name for Leronlimab as a Combination Therapy for Highly Treatment Experienced HIV Patients in the United States

Retrieved on: 
Monday, April 27, 2020
Hepatotoxins, Drugs, RTT, Prevention of HIV/AIDS, Medical specialties, HIV/AIDS, Management of HIV/AIDS, Zidovudine, PRO 140, CCR5 receptor antagonist

Food and Drug Administration(FDA) of the proprietary name Vyrologix (pronounced - vie-ro-loj-iks) for leronlimab as a combination therapy for highly treatment experienced HIV patients in the United States.

Key Points: 
  • Food and Drug Administration(FDA) of the proprietary name Vyrologix (pronounced - vie-ro-loj-iks) for leronlimab as a combination therapy for highly treatment experienced HIV patients in the United States.
  • We are pleased to receive the FDAs conditional acceptance of Vyrologix as the proprietary name for leronlimabs combination therapy treatment of HIV, said Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn.
  • CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients.
  • CytoDyn completed the filing of its BLA in April 2020 to seek FDA approval for leronlimab as a combination therapy for highly treatment experienced HIV patients.

CytoDyn Submits Completed Biologics License Application (BLA) to the FDA for Leronlimab as a Combination Therapy for Highly Treatment Experienced HIV Patients

Retrieved on: 
Monday, April 27, 2020
Health, Drugs, Hepatotoxins, Food and Drug Administration, United States Public Health Service, Zidovudine, Management of HIV/AIDS, Fast track, PRO 140, Ibalizumab

The FDA previously granted both Fast Track designation for leronlimab and rolling review for the Companys BLA in HIV indication.

Key Points: 
  • The FDA previously granted both Fast Track designation for leronlimab and rolling review for the Companys BLA in HIV indication.
  • The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases.
  • CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients.
  • CytoDyn completed the filing of its BLA in April 2020 to seek FDA approval for leronlimab as a combination therapy for highly treatment experienced HIV patients.