AIDS Clinical Trials Group

AIDS Clinical Trial Group Presents Results from Phase 1 Study of ModeX Trispecific Antibody for the Treatment and Prevention of HIV

Retrieved on: 
Tuesday, March 5, 2024

WESTON, Mass., March 05, 2024 (GLOBE NEWSWIRE) -- ModeX Therapeutics Inc., an OPKO Health company (NASDAQ: OPK), today announced results from a Phase 1 clinical study of SAR441236, its trispecific broadly neutralizing antibody against the human immunodeficiency virus (HIV), at the 2024 Conference on Retroviruses and Opportunistic Infections (CROI) in Denver, Colorado. These clinical data are the first reported for a trispecific antibody and specifically provide support for the further development of multispecific, multivalent antibodies against HIV as a differentiated approach to addressing HIV infection.

Key Points: 
  • These clinical data are the first reported for a trispecific antibody and specifically provide support for the further development of multispecific, multivalent antibodies against HIV as a differentiated approach to addressing HIV infection.
  • The study enrolled 52 participants and was conducted by the AIDS Clinical Trials Group (ACTG), a clinical trials network funded by the National Institute of Allergy and Infectious Diseases, NIH.
  • The antibody was safe and well-tolerated at all dose levels and via both intravenous and subcutaneous administration.
  • These clinical data on an HIV multispecific antibody inform the future advancement of such antibodies for the prevention and treatment of HIV and provide strong rationale for the development of current and future antibody products.

ACTG Announces Publication of REPRIEVE Trial in New England Journal of Medicine and Presentation at IAS 2023

Retrieved on: 
Monday, July 24, 2023

Today’s publication coincides with the symposium “The REPRIEVE trial: Developing a Cardiovascular Disease Prevention Strategy for People Living with HIV,” taking place today at IAS 2023, the 12th IAS Conference on HIV Science, in Brisbane, Australia.

Key Points: 
  • Today’s publication coincides with the symposium “The REPRIEVE trial: Developing a Cardiovascular Disease Prevention Strategy for People Living with HIV,” taking place today at IAS 2023, the 12th IAS Conference on HIV Science, in Brisbane, Australia.
  • “REPRIEVE is an extraordinarily important study because it addresses the need for interventions to prevent cardiovascular events in people living with HIV,” said ACTG Chair Judith Currier, M.D., M.Sc., University of California, Los Angeles.
  • The 35 percent reduction in MACE was consistent across key study groups, including sex, race, and global burden of disease region.
  • These conclusions are based on a review of the data by an Independent Data and Safety Monitoring Board, which stopped the trial early.

ACTG Announces Publication of New Insights Into HIV Reservoirs and Prospects for Remission in the Journal of Infectious Diseases

Retrieved on: 
Monday, March 27, 2023

This publication found that levels of intact proviral DNA (inactive HIV DNA that may be capable of replicating) initially decay rapidly but that decay markedly slows among virally suppressed people living with HIV on long-term ART.

Key Points: 
  • This publication found that levels of intact proviral DNA (inactive HIV DNA that may be capable of replicating) initially decay rapidly but that decay markedly slows among virally suppressed people living with HIV on long-term ART.
  • The study also found a late increase in proviral DNA levels among some individuals.
  • A recently developed assay is able to distinguish between intact proviruses (which may be able to replicate) and defective proviruses (which cannot).
  • “This study provides crucial insights into the patterns of HIV reservoir decay.

ACTG Announces Publication of Pivotal Hepatitis C Study in Clinical Infectious Diseases

Retrieved on: 
Monday, March 27, 2023

LOS ANGELES, March 27, 2023 (GLOBE NEWSWIRE) -- The AIDS Clinical Trials Group (ACTG), the world’s largest HIV research network, is announcing the publication of “Perspectives on Adherence from the ACTG 5360 MINMON Trial: A Minimum Monitoring Approach with 12 Weeks of Sofosbuvir/Velpatasvir in Chronic Hepatitis C Treatment” in the journal Clinical Infectious Diseases.

Key Points: 
  • LOS ANGELES, March 27, 2023 (GLOBE NEWSWIRE) -- The AIDS Clinical Trials Group (ACTG), the world’s largest HIV research network, is announcing the publication of “Perspectives on Adherence from the ACTG 5360 MINMON Trial: A Minimum Monitoring Approach with 12 Weeks of Sofosbuvir/Velpatasvir in Chronic Hepatitis C Treatment” in the journal Clinical Infectious Diseases.
  • This publication found that self-reported 100 percent adherence in the first four weeks of hepatitis C treatment with sofosbuvir/velpatasvir was associated with sustained virologic response (which is when no hepatitis C virus is found in the blood 12 weeks after completing treatment).
  • Direct-acting antivirals have transformed the treatment landscape for people with hepatitis C, resulting in dramatically improved treatment outcomes.
  • The MINMON trial was designed to reduce overall treatment cost by having fewer in-person clinic visits, and less laboratory monitoring that typically accompany hepatitis C treatment.

Shionogi Advances Ensitrelvir Fumaric Acid COVID-19 Antiviral Clinical Program

Retrieved on: 
Wednesday, February 15, 2023

Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi") today announced progress on its comprehensive clinical development program for the novel COVID-19 oral antiviral ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.

Key Points: 
  • Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi") today announced progress on its comprehensive clinical development program for the novel COVID-19 oral antiviral ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.
  • The program includes several Phase 3 clinical studies evaluating ensitrelvir’s safety and effectiveness across a wide range of COVID-19 patient populations.
  • Ensitrelvir is the first drug to be evaluated in the STRIVE program, a new agile research approach set up to rapidly assess interventions during epidemics adversely affecting public health.
  • Pediatric Trial: Shionogi plans to initiate a Phase 3 pediatric study evaluating the safety and effectiveness of ensitrelvir for children ages 6-12 in Japan, starting in early 2023.

New PLI Press Treatise Covers California's Complex Employment Laws

Retrieved on: 
Thursday, October 27, 2022

A new treatise from PLI Press, California Employment Law, serves as a comprehensive resource on the statutes and case law governing the employer-employee relationship in the state, providing practical guidance on state, local, and federal rules and regulations.

Key Points: 
  • A new treatise from PLI Press, California Employment Law, serves as a comprehensive resource on the statutes and case law governing the employer-employee relationship in the state, providing practical guidance on state, local, and federal rules and regulations.
  • It analyzes key provisions of laws such as the California Fair Employment and Housing Act and the California Labor Code and Wage Orders, while highlighting the significant differences between state and federal laws.
  • To learn more about this title, please visit pli.edu/CAEmploymentLaw
    Lindsay Hutner is Co-Chair of the Labor & Employment Practice's Employment Litigation & Trials Group at Greenberg Traurig LLP.
  • PLI publishes a comprehensive library of treatises, course handbooks, answer books, and journals, also available through the PLI PLUS online platform.

Synairgen announces positive data from the US NIH-led ACTIV-2 Phase 2 trial for SNG001 in home-based participants with COVID-19

Retrieved on: 
Tuesday, October 4, 2022

There were no statistically significant differences between SNG001 and placebo with respect to the primary outcomes of safety (SNG001 was well-tolerated), symptom resolution, or virology.

Key Points: 
  • There were no statistically significant differences between SNG001 and placebo with respect to the primary outcomes of safety (SNG001 was well-tolerated), symptom resolution, or virology.
  • Based on the study results, the Independent Data Safety Monitoring Board for ACTIV-2 recommended SNG001 advance from Phase 2 into Phase 3 in the ACTIV-2 trial in October 2021.
  • We will now begin to evaluate the full data set and factor these findings into our development plans.
  • 2 Synairgen conducted a trial of SNG001 in high-risk, home-based COVID-19 patients (SG016) in which fewer patients treated with SNG001 were hospitalised (0/56) compared to placebo (2/58).

Cend Therapeutics Announces First Patient Treated in Phase 2b Trial of CEND-1 led by Australasian Gastro-Intestinal Trials Group

Retrieved on: 
Thursday, June 9, 2022

The ASCEND trial is a 125-patient, double-blind, randomized, placebo-controlled clinical trial, and is being conducted at up to 40 sites in Australia and New Zealand.

Key Points: 
  • The ASCEND trial is a 125-patient, double-blind, randomized, placebo-controlled clinical trial, and is being conducted at up to 40 sites in Australia and New Zealand.
  • Designed and led by the Australasian Gastro-Intestinal Trials Group (AGITG) in collaboration with the NHMRC Clinical Trial Centre at the University of Sydney, Cend will provide funding, study drug and regulatory support.
  • Dosing the first patient in our Phase 2b trial represents a significant accomplishment for our team as we have worked diligently to achieve this milestone, stated Harri Jrvelinen, Chief Operating Officer of Cend.
  • Pancreatic cancer has one of the highest mortality rates of all cancers and affects hundreds of thousands of patients each year.

SAB Biotherapeutics Announces Update to the Phase 3 NIH ACTIV-2 Trial Design Evaluating SAB-185 for Treatment of COVID-19

Retrieved on: 
Friday, February 25, 2022

SIOUX FALLS, S.D., Feb. 25, 2022 (GLOBE NEWSWIRE) -- SAB Biotherapeutics (SAB) (Nasdaq: SABS), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that produces specifically targeted, high-potency, fully-human polyclonal antibodies without the need for human donors, today announced an update to the design of the ongoing Phase 3 ACTIV-2 trial evaluating the clinical efficacy and safety of SAB-185 for the treatment of participants with mild-moderate COVID infections at higher risk for progression to hospitalization. The Phase 3 trial had been designed as an open-label, randomized non-inferiority study comparing SAB-185 to an active comparator—a monoclonal antibody cocktail (casirivimab and imdevimab) authorized for treatment of COVID-19. Going forward, the active comparator will be replaced with a placebo.

Key Points: 
  • We are encouraged that NIH chose to update and continue this Phase 3 study as a placebo-controlled trial.
  • The ACTIV-2 trial is designed to rapidly assess potential new therapies for COVID-19 utilizing an adaptive platform trial design.
  • Under the new update, the Phase 3 trial design is amended to pivot to a blinded, randomized, placebo-controlled superiority trial.
  • SAB Biotherapeutics, Inc. (SAB) is a clinical-stage, biopharmaceutical company advancing a new class of immunotherapies leveraging fully human polyclonal antibodies.

Greenberg Traurig's Lindsay Hutner and Philip Person to Participate in Wage & Hour Litigation Conference

Retrieved on: 
Tuesday, December 7, 2021

SAN FRANCISCO, Dec. 7, 2021 /PRNewswire-PRWeb/ -- Lindsay E. Hutner , shareholder and co-chair of global law firm Greenberg Traurig LLP's Labor & Employment (L&E) Practice's Employment Litigation & Trials Group, and Philip I.

Key Points: 
  • SAN FRANCISCO, Dec. 7, 2021 /PRNewswire-PRWeb/ -- Lindsay E. Hutner , shareholder and co-chair of global law firm Greenberg Traurig LLP's Labor & Employment (L&E) Practice's Employment Litigation & Trials Group, and Philip I.
  • Person , shareholder and co-chair of the firm's Restructuring & Employment Due Diligence Subgroup, will speak at the 2021 Wage & Hour Litigation and Management Conference hosted by Bridgeport Continuing Education Dec. 10.
  • Hutner, who will also co-chair the event, will be presenting on new legislative updates applicable to California wage and hour law.
  • Person will speak on a panel titled "Wage & Hour Issues Affecting Low Wage Workers."