Management of HIV/AIDS

CytoDyn Receives Positive DSMC Recommendation for Leronlimab Phase 3 COVID-19 Trial with No Safety Concerns

Retrieved on: 
Tuesday, August 4, 2020

The DSMC did not raise any concerns regarding safety and recommended that the trial continue.

Key Points: 
  • The DSMC did not raise any concerns regarding safety and recommended that the trial continue.
  • CytoDyn completed its Phase 2 clinical trial (CD10) for COVID-19, a randomized clinical trial for mild-to-moderate patients in the U.S. and is currently evaluating the data.
  • 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.

UPDATE - Impressive Results From CytoDyn’s Phase 2 COVID-19 Trial

Retrieved on: 
Tuesday, July 21, 2020

Scott Kelly, M.D., CytoDyns Chief Medical Officer, commented, We are very pleased with the safety results in the double-blinded, placebo-controlled study of the mild-to-moderate COVID-19 population.

Key Points: 
  • Scott Kelly, M.D., CytoDyns Chief Medical Officer, commented, We are very pleased with the safety results in the double-blinded, placebo-controlled study of the mild-to-moderate COVID-19 population.
  • 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.

Impressive Results From CytoDyn’s Phase 2 Covid-19 Trial

Retrieved on: 
Tuesday, July 21, 2020

Scott Kelly, M.D., CytoDyns Chief Medical Officer, commented, We are very pleased with the safety results in the double-blinded, placebo-controlled study of the mild-to-moderate COVID-19 population.

Key Points: 
  • Scott Kelly, M.D., CytoDyns Chief Medical Officer, commented, We are very pleased with the safety results in the double-blinded, placebo-controlled study of the mild-to-moderate COVID-19 population.
  • 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 Files Application with Nasdaq for Uplist

Retrieved on: 
Wednesday, July 15, 2020

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented: While we realize the regulatory review of our application to uplist to Nasdaq will take several weeks, we believe the Company is well positioned for success.

Key Points: 
  • Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented: While we realize the regulatory review of our application to uplist to Nasdaq will take several weeks, we believe the Company is well positioned for success.
  • 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 is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients.

Gilead Sciences Presents Data Supporting a Potential Six-Month Dosing Interval for Investigational HIV-1 Capsid Inhibitor Lenacapavir (GS-6207)

Retrieved on: 
Saturday, July 4, 2020

Lenacapavir is an investigational agent that is being developed as a component of a long-acting regimen in combination with other antiretroviral agents.

Key Points: 
  • Lenacapavir is an investigational agent that is being developed as a component of a long-acting regimen in combination with other antiretroviral agents.
  • Lenacapavir disrupts HIV capsid, a multimeric shell that is essential to viral replication, at multiple stages throughout the viral life cycle.
  • All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
  • Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc. or its related companies.

FDA Approves New HIV Treatment for Patients With Limited Treatment Options

Retrieved on: 
Thursday, July 2, 2020

"This approval marks a new class of antiretroviral medications that may benefit patients who have run out of HIV treatment options," said Jeff Murray, M.D., deputy director of the Division of Antivirals in the FDA's Center for Drug Evaluation and Research.

Key Points: 
  • "This approval marks a new class of antiretroviral medications that may benefit patients who have run out of HIV treatment options," said Jeff Murray, M.D., deputy director of the Division of Antivirals in the FDA's Center for Drug Evaluation and Research.
  • "The availability of new classes of antiretroviral drugs is critical for heavily treatment-experienced patients living with multidrug resistant HIV infectionhelping people living with hard-to-treat HIV who are at greater risk for HIV-related complications, to potentially live longer, healthier lives."
  • Most participants had been treated for HIV for more than 15 years (71 percent), had been exposed to five or more different HIV treatment regimens before entering the trial (85 percent) and/or had a history of AIDS (86 percent).
  • After 24 weeks of Rukobia plus other antiretroviral drugs, 53 percent of participants achieved HIV RNA suppression, where levels of HIV were low enough to be considered undetectable.

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

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.

Merck Underscores Commitment to HIV with New Data Analyses to be Presented at AIDS 2020: Virtual

Retrieved on: 
Wednesday, June 24, 2020

Select abstracts in the AIDS 2020 program include:

Key Points: 
  • Select abstracts in the AIDS 2020 program include:
    Islatravir Safety Analysis Through Week 48 From A Phase 2 Trial in Treatment Nave Adults With HIV-1 Infection.
  • Doravirine Resistance Profile in Clinical Isolates and Impact of Baseline NNRTI Resistance-Associated Mutations Observed in Treatment-Nave Participants from Phase 3 Clinical Trials.
  • For more information, including details around the virtual programming, please visit the AIDS 2020 website .
  • Our focus is on pursuing research that addresses unmet medical needs and helps people living with HIV and their communities.

FDA Approves Drug to Treat Infants and Children with HIV

Retrieved on: 
Friday, June 12, 2020

"For babies and young children with HIV, getting treatment early is very important.

Key Points: 
  • "For babies and young children with HIV, getting treatment early is very important.
  • HIV can progress more quickly in children than adults," said Debra Birnkrant, M.D., director of the Division of Antivirals in FDA's Center for Drug Evaluation and Research.
  • "While the incidence of pediatric HIV infections continues to decline, the availability and early initiation of effective treatment are critical for infants and children living with HIV.
  • Tivicay and Tivicay PD are taken once daily, which could help patients and caregivers better adhere to the regimen.

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

Retrieved on: 
Thursday, June 11, 2020

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.