An independent Data and Safety Monitoring Board has completed the successful review of the safety data of the Phase IIb clinical trial of TNF-Kinoid in rheumatoid arthritis
An independent Data and Safety Monitoring Board has completed the successful review of the safety data of the Phase IIb clinical trial of TNF-Kinoid in rheumatoid arthritis (RA), according to an annual statement issued by Neovacs.
The biotech company, which focuses on an active immunotherapy technology platform with applications in autoimmune and/or inflammatory diseases, has now received a final report in with unrestricted approval of the study. The committee of four international auto-immune disease experts have confirmed the good safety profile of the Kinoid at the actual stage of the study, and made a unanimous recommendation to pursue the study without modification, stated Neovacs.
"From a clinical point of view, 2013 was an important year for Neovacs, with the launch of our phase IIb trial in RA. 2014 will also be a critical year. The RA clinical study is progressing according to schedule,” said Miguel Sieler, CEO of Neovacs. “We are also resuming preclinical studies with three other Kinoids, in order to maintain our leadership position in the development of immunotherapies for the treatment of auto-immune diseases, chronic infections and cancer. I am confident that the clinical data that we will present in 2014 will prove the efficacy of our products, and allow Neovacs to reach the next phase of its development".
Read the full release here.
Empowering Sites and Patients: The Impact of Personalized Support in Clinical Trials
November 26th 2024To meet the growing demands of clinical research, sponsors must prioritize comprehensive support models, such as clinical site ambassadors and patient journey coordinators, who can address operational challenges and improve site relationships, patient satisfaction, and overall trial efficiency.
Driving Diversity with the Integrated Research Model
October 16th 2024Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and challenges with achieving greater diversity in clinical trials, how integrated research organizations are bringing care directly to patients, and more.
FDA Finalizes Decentralized Clinical Trial Guidance
November 25th 2024The FDA's guidance is part of a broader effort to modernize clinical trials, improve efficiency, reduce participant burden, and expand access, particularly for underrepresented populations and those in geographically or economically constrained areas.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.