Management of HIV/AIDS

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.

CytoDyn’s CEO Dr. Pourhassan and CMO Dr. Kelly to Appear on DrBeen Webcast Tuesday, September 22, 2020

Retrieved on: 
Monday, September 21, 2020
Medical specialties, PRO 140, Health, Drugs, Breast cancer, CCR5, Triple-negative breast cancer, CCR5 receptor antagonist, Management of HIV/AIDS, Invasión, Cancer, HIV

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

Key Points: 
  • The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses.
  • The first indication is a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer.
  • 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.
  • In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control.

Global Health Leaders Join CytoDyn's Scientific Advisory Board

Retrieved on: 
Tuesday, September 1, 2020
PRO 140, Health, Drugs, Medicine, Triple-negative breast cancer, Management of HIV/AIDS, Indication, Food and Drug Administration, Breast cancer, CCR5 receptor antagonist

Dr. Kelly continued, "The combined years of medical practice, investigative trial experience and publications are more than impressive; we believe the collective wisdom and experience of these leaders will be the pathway to rapidly bringing leronlimab to the global health community.

Key Points: 
  • Dr. Kelly continued, "The combined years of medical practice, investigative trial experience and publications are more than impressive; we believe the collective wisdom and experience of these leaders will be the pathway to rapidly bringing leronlimab to the global health community.
  • We will continue to expand this team with a focus on specific oncology indications, neurology, pulmonary and critical care, virology, and autoimmune diseases."
  • The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses.
  • The first indication is a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer.

CytoDyn Reaches Enrollment of 195 Patients in its Phase 3 Trial for COVID-19 Patients with Severe-to-Critical Symptoms

Retrieved on: 
Wednesday, August 26, 2020
Health, Medical specialties, Medicine, PRO 140, Triple-negative breast cancer, HIV/AIDS, Clinical research, CCR5 receptor antagonist, Management of HIV/AIDS, Clinical trial, Graft-versus-host disease

Recently, the Data Safety Monitoring Committee (DSMC) completed its first safety review of patients in the Phase 3 trial and reported it saw no cause to modify the study.

Key Points: 
  • Recently, the Data Safety Monitoring Committee (DSMC) completed its first safety review of patients in the Phase 3 trial and reported it saw no cause to modify the study.
  • 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.

GeoVax Announces Clinical Trial Initiation of Novel Combination Therapy Utilizing MVA62B to Induce Remission in HIV-Positive Patients

Retrieved on: 
Monday, August 24, 2020
Prevention of HIV/AIDS, Medical specialties, HIV/AIDS, HIV vaccine, Hypothetical technology, Vaccines, Clinical medicine, GeoVax, Management of HIV/AIDS, Vaccine, Division of Acquired Immunodeficiency Syndrome, HIV/AIDS research

(OTCQB: GOVX), a biotechnology company developing human immunotherapies and vaccines against infectious diseases and cancer, announced today initiation of a Phase 1 clinical study of a combination therapy in HIV-positive patients utilizing GeoVaxs novel boost component MVA62B.

Key Points: 
  • (OTCQB: GOVX), a biotechnology company developing human immunotherapies and vaccines against infectious diseases and cancer, announced today initiation of a Phase 1 clinical study of a combination therapy in HIV-positive patients utilizing GeoVaxs novel boost component MVA62B.
  • The single-arm, open-label study will enroll 20 HIV-infected adults who are on stable and effective antiretroviral therapy (ART) .
  • GeoVax is providing its novel boost component, MVA62B, for use in the studies.
  • MVA62B is the boosting component for GeoVaxs preventive HIV vaccine, GOVX-B11, which has successfully completed a Phase 2a clinical trial.

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.

Global HIV Tests Market: Impact of COVID-19 for 2020 and Beyond - ResearchAndMarkets.com

Retrieved on: 
Thursday, August 6, 2020
Professional services, Consulting, HIV/AIDS, Medical specialties, Hepatotoxins, Management of HIV/AIDS, Diagnosis of HIV/AIDS, Clinical medicine, Vaccines, Fellows of the Royal College of Physicians, HIV and pregnancy, HIV vaccine

The "HIV Tests (In Vitro Diagnostics) - Global Market Analysis and Forecast Model (COVID-19 market impact)" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "HIV Tests (In Vitro Diagnostics) - Global Market Analysis and Forecast Model (COVID-19 market impact)" report has been added to ResearchAndMarkets.com's offering.
  • The model discusses in detail the impact of COVID-19 on HIV Tests market for the year 2020 and beyond.
  • HIV tests are performed for two purposes: i) screening and diagnosis; or ii) monitoring of HIV-positive patients, particularly those undergoing antiretroviral therapy (ART).
  • Track device sales in the global and country-specific HIV Tests market from 2015-2030.