APEIRON Biologics Initiates Phase II Clinical Trial of APN01 for Treatment of COVID-19.
CTC North is very pleased to be the performing contract research institute for this project.
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New research project to cure hepatitis B patients under the European Horizon 2020 programme.
On 1t January, 2020 a new research project in hepatitis B has started under the European Horizon 2020 programme. The main objective of the TherVacB project is to develop a therapeutic vaccine to cure hepatitis B patients.
More than three percent of the world's population (about 260 million humans) are chronically infected with the hepatitis B virus (HBV). Worldwide 880,000 humans die each year from the sequelae: liver cirrhosis and hepatocellular carcinoma. Currently, there is no cure. The therapeutic vaccine TherVacB aims to cure patients with chronic hepatitis B. A consortium of leading virologists, immunologists and specialized physicians will use a newly designed vaccine as an immunotherapy in a two-year clinical trial starting in 2021. With three vaccine shots, one every four weeks, the vaccine induces neutralizing antibodies and T-cell responses. At first, two protein antigens are injected, followed by an MVA (“modified vaccinia virus Ankara”) vector. This vector is designed to express hepatitis B viruses found worldwide. Since Africa suffers from a high infection rate and particular HBV viruses can be found there, part of the clinical trial will be conducted in Tanzania. This shall also help building local capacities for diagnosing and treating hepatitis B.
Project coordinator Prof. Ulrike Protzer on the benefits of the project: "I am highly pleased that for the clinical trials of TherVacB we are able to cooperate with a consortium of Europe’s leading virologists, immunologists and hepatologist, guided by Helmholtz Zentrum München. This will be of great benefit for the patients chronically infected with the hepatitis B virus."
CTC North will be responsible for the management of the clinical trial within the TherVacB project. “We look forward to being partner in this exciting project and to contribute our long and extensive experience with Investigator-Initiated-Trials (studies with non-commercial sponsors) to the project” Dr. Saskia Borregaard, Director Clinical Trial Management at CTC Norths states. “Academic clinical trials with its primary goal of improving medical treatment for patients without financial interest are an essential element of clinical research".
TherVacB is supported by H2020 with 10.426.000 million Euros. The project runs over five years and will end on 31 December, 2024.
The parties involved
The TherVacB project is coordinated by Helmholtz Zentrum München and unites public research organisations from across Europe: Klinikum Rechts der Isar der Technischen Universität München, Universitätsklinikum Hamburg-Eppendorf, Medizinische Hochschule Hannover, Helmholtz-Zentrum für Infektionsforschung GmbH, Ludwig-Maximilians-Universität München, Universität Leipzig, Technische Universität München (Germany); National Institute for Medical Research (Tanzania); Fundacio Clinic per a la Recerca Biomedica (Spain); Azienda Ospedaliero-Universitaria di Parma (Italy); University College London, Barts and the London NHS Trust, Royal Free London NHS
Foundation Trust (United Kingdom), supported by Biotechnology related enterprise members CTC North GmbH &Co. KG (Germany) and ARTTIC (France).
About Horizon 2020 Programme
Horizon 2020 is the biggest EU Research and Innovation programme ever with nearly 80 billion Euros of funding available over seven years (2014 to 2020). It promises more breakthroughs, discoveries and world-firsts by taking great ideas from the lab to the market. The project is funded in a specific call about innovative treatments and technologies such as gene or cell therapies. With this specific call the European Union aims to improve the development of advanced methods and devices for targeted and controlled delivery, and to bring these innovative treatments to the patient.
About CTC North
CTC North is an independent Clinical Research Organization located on the campus of the University Medical Center Hamburg-Eppendorf. Its goal is to guarantee the professional organization and management of clinical studies according to ICH-GCP and applicable national and European laws and regulations within a university environment. Since 2006, CTC North has offered a comprehensive range of services in all areas of clinical trials. CTC North has many years of experience in the conduct of clinical trials and in the coordination of multicenter clinical trials, in particular trials with non-commercial sponsors (IITs).
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Dr. Saskia Borregaard: firstname.lastname@example.org
This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 848223.
Several premier research centers in Germany have led the initiative and joined the global Verified Clinical Trials (VCT) research subject database registry to prevent duplicate subjects and other important protocol violations in an effort to improve safety and data quality in their clinical trials.