Zidovudine

ViiV Healthcare announces dolutegravir plus lamivudine three-year data confirming long-term viral suppression non-inferior to a 3-drug regimen for treatment-naïve adults with HIV-1

Retrieved on: 
Monday, October 5, 2020
Science, Biotechnology, Research, Pharmaceutical, AIDS, Health, Infectious diseases, Clinical trials, Hepatotoxins, RTT, Drugs, Dolutegravir, Management of HIV/AIDS, Lamivudine, Abacavir/dolutegravir/lamivudine, Zidovudine, Dolutegravir/lamivudine, GEMINI 1 & 2, Dovato (dolutegravir/lamivudine)

Dolutegravir plus lamivudine continues to demonstrate long-term non-inferior efficacy compared to dolutegravir plus TDF/FTC with benefits beyond viral suppression.

Key Points: 
  • Dolutegravir plus lamivudine continues to demonstrate long-term non-inferior efficacy compared to dolutegravir plus TDF/FTC with benefits beyond viral suppression.
  • While overall adverse event rates were similar across the study arms, we saw fewer drug-related adverse events with dolutegravir plus lamivudine.
  • Dolutegravir plus lamivudine continued to demonstrate a high genetic barrier to treatment-emergent resistance.
  • These studies evaluate a 2-drug regimen of dolutegravir plus lamivudine compared with a 3-drug regimen of dolutegravir plus TDF/FTC in HIV-1 infected, antiretroviral treatment-nave adult participants with baseline HIV-1 viral loads between 1,000 and 500,000 c/mL.

CytoDyn’s Phase 2 Study of Leronlimab for Mild-to-Moderate COVID-19 Selected for Oral Presentation at the Special isirv-AVG Virtual Conference on ‘Therapeutics for COVID-19’

Retrieved on: 
Wednesday, September 23, 2020
Drugs, PRO 140, Hepatotoxins, Medical specialties, Retroviridae, HIV/AIDS, Management of HIV/AIDS, CCR5 receptor antagonist, HIV, Zidovudine

Details of the presentation are as follows:

Key Points: 
  • Details of the presentation are as follows:
    Presenter: Harish Seethamraju, M.D., Medical Director, Advanced Lung Failure and Lung Transplant, Montefiore Medical Center, Bronx, New York.
  • The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses.
  • Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans.
  • CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients.

After Several Months of Providing Requested Information About Manufacturing and Safety of Leronlimab, U.K.’s MHRA Accepts CytoDyn’s Request to Enroll in its Current Phase 3 Trial for COVID-19 Patients with Severe-to-Critical Symptoms

Retrieved on: 
Thursday, August 20, 2020
Drugs, Hepatotoxins, Health, PRO 140, Medical specialties, Prevention of HIV/AIDS, HIV/AIDS, Coronavirus disease, Management of HIV/AIDS, Zidovudine, Pivotal trial, CCR5 receptor antagonist

The MHRAs decision follows several months of its review of CytoDyns manufacturing processes and leronlimabs safety profile.

Key Points: 
  • The MHRAs decision follows several months of its review of CytoDyns manufacturing processes and leronlimabs safety profile.
  • CytoDyn recently requested fast track approval from the MHRA for its completed Phase 2 COVID-19 trial for the mild-to-moderate population, with strong efficacy and safety data.
  • The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure.
  • CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients.

CytoDyn Submits its Top-line Report from its Phase 2 COVID-19 Trial to the U.S. FDA and Requests Emergency Use Approval

Retrieved on: 
Monday, August 17, 2020
Health, Drugs, PRO 140, Medical research, Hepatotoxins, Triple-negative breast cancer, Clinical research, Pharmaceutical industry, CCR5 receptor antagonist, Management of HIV/AIDS, Clinical trial, Zidovudine

We are in discussions with several regulatory agencies in other countries and hope to obtain emergency approval for its use.

Key Points: 
  • We are in discussions with several regulatory agencies in other countries and hope to obtain emergency approval for its use.
  • 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 Seeks UK Approval of Leronlimab for HIV and COVID-19

Retrieved on: 
Friday, August 7, 2020
Health, Drugs, Hepatotoxins, Clinical research, PRO 140, HIV/AIDS, Management of HIV/AIDS, Zidovudine, Clinical trial, CCR5 receptor antagonist, Placebo, HIV

We will also pursue cancer indications in all these countries, as well as other potential indications for leronlimab.

Key Points: 
  • We will also pursue cancer indications in all these countries, as well as other potential indications for leronlimab.
  • The Company previously announced patients receiving leronlimab experienced 64% fewer serious adverse events (SAEs) during the trial than patients receiving placebo.
  • Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans.
  • CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients.

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

Retrieved on: 
Tuesday, July 21, 2020
Drugs, Health, Hepatotoxins, PRO 140, Medicine, Clinical research, Prevention of HIV/AIDS, Triple-negative breast cancer, Management of HIV/AIDS, Zidovudine, Placebo, CCR5 receptor antagonist

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
Drugs, Health, Hepatotoxins, PRO 140, Medicine, Clinical research, Prevention of HIV/AIDS, Triple-negative breast cancer, Management of HIV/AIDS, Zidovudine, Placebo, CCR5 receptor antagonist

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
Hepatotoxins, Drugs, RTT, HIV/AIDS, Chemical substances, Management of HIV/AIDS, Prevention of HIV/AIDS, Zidovudine, PRO 140, CCR5 receptor antagonist

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
Biotechnology, AIDS, Hospitals, Health, Pharmaceutical, Hepatotoxins, RTT, Specialty drugs, Articles, Chemical substances, Biotechnology, Prevention of HIV/AIDS, Gilead Sciences, Management of HIV/AIDS, HIV, Zidovudine

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.

CytoDyn Releases Mechanism of Action Animation for Leronlimab in Immuno-Oncology

Retrieved on: 
Thursday, July 2, 2020
Drugs, Medicine, Clinical medicine, RTT, Cancer immunotherapy, Zidovudine, Orphan drugs, Breakthrough therapy, Pelareorep, PRO 140

CytoDyn is currently exploring the efficacy of leronlimab for several immuno-oncology indications, including metastatic triple-negative breast cancer, a mechanism of action basket trial for 22 solid tumors, and a Phase 2 combination therapy for metastatic colorectal cancer.

Key Points: 
  • CytoDyn is currently exploring the efficacy of leronlimab for several immuno-oncology indications, including metastatic triple-negative breast cancer, a mechanism of action basket trial for 22 solid tumors, and a Phase 2 combination therapy for metastatic colorectal cancer.
  • The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases.
  • CytoDyn has Fast Track designation for leronlimab and a rolling review for its BLA, as previously assigned 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.