The study will primarily evaluate the safety and tolerability of the HBV immunotherapeutic, pdpSC18, administered by PMED™, PowderMed’s needle-free delivery technology, in patients with chronic hepatitis B infection, both in combination with lamivudine and as monotherapy. Additionally, assessments of immunogenicity and clinical response will be made.
Worldwide HBV affects 350 million people and there are no commercially available therapeutic vaccines for the treatment of chronic HBV infection. Chronic infection occurs in 98% of newborn children infected by vertical transmission from the mother (the most common means of transmission in Asia-Pacific), and in 5% of individuals infected after 2 years of age. About 25% of these patients will progress to cirrhosis and 20% of this subgroup will develop hepatocellular carcinoma – one of the most common cancers worldwide.
Welcoming this study and the potential for a novel therapeutic vaccine to HBV, Dr Antonio Bertoletti, of the Center for Molecular Medicine, Singapore, said:
“Patients with chronic hepatitis B show a state of relative hypo-responsiveness of HBV-specific T cells compared with that demonstrated in patients who control the virus replication after acute infection. Therapeutic induction and/or activation of the T-cell response for HBV core and surface proteins may have the potential to control infection. It has been shown that Hepatitis B surface (HBsAg) and core antigen (HBcAg) induces envelope-and core specific CD4+ and CD8+ T-cell responses and that the response against the Hepatitis B core antigen (HBcAg), is often associated with viral control. The combination of these two genes in PowderMed’s pdpSC18 HBV therapeutic DNA vaccine, thus provides a potential mechanism to both clear the virus via the CD8+ response and to overcome unresponsiveness in chronically infected patients via the CD4+ response.”
This Phase I, First Time in Human Study will enrol patients at seven sites in SE Asia (Singapore, Taiwan, Hong Kong) and the USA. Since the immunological response and hepatic tolerability of the hepatitis B immunotherapeutic would be expected to differ considerably between non-infected subjects and subjects with active hepatitis B disease, the Phase I clinical study will enrol subjects with active hepatitis B disease in order to specifically address both safety and immunogenicity in the most predictive manner possible. Each subject will participate in the study for a period of up to 27 weeks, plus a 4-week run-in and screening period. Allowing for the planned safety reviews between dosing cohorts and a 4-month recruitment window, results can be expected during 2007.
Commenting on the trial, Dr John Beadle, PowderMed’s Chief Medical Officer, said:
“Given the limitations of the currently available treatment regimens for chronic Hepatitis B, a regimen, either as a monotherapy or combination, that could provide enhanced clearance of virus, seroconversion, a reduction in resistant strains or a reduction in post-treatment exacerbations of hepatitis would be highly desirable. The concept of a novel DNA therapeutic vaccine to boost the immune response to the virus and promote viral clearance is thus an attractive and timely novel therapeutic strategy in an area of substantial unmet medical need.”
Phase I clinical trials of a prophylactic DNA Vaccine containing only the HBsAg gene (pPWRG7128) in 95 subjects, showed that vaccination via PMED™ was generally well tolerated both locally and systemically, and resulted in seroprotective levels of antibodies and measurable cell-mediated immune responses.
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02.12.2016 | Salk Institute
Fertilized egg cells trigger and monitor loss of sperm’s epigenetic memory
02.12.2016 | IMBA - Institut für Molekulare Biotechnologie der Österreichischen Akademie der Wissenschaften GmbH
A multi-institutional research collaboration has created a novel approach for fabricating three-dimensional micro-optics through the shape-defined formation of porous silicon (PSi), with broad impacts in integrated optoelectronics, imaging, and photovoltaics.
Working with colleagues at Stanford and The Dow Chemical Company, researchers at the University of Illinois at Urbana-Champaign fabricated 3-D birefringent...
In experiments with magnetic atoms conducted at extremely low temperatures, scientists have demonstrated a unique phase of matter: The atoms form a new type of quantum liquid or quantum droplet state. These so called quantum droplets may preserve their form in absence of external confinement because of quantum effects. The joint team of experimental physicists from Innsbruck and theoretical physicists from Hannover report on their findings in the journal Physical Review X.
“Our Quantum droplets are in the gas phase but they still drop like a rock,” explains experimental physicist Francesca Ferlaino when talking about the...
The Max Planck Institute for Physics (MPP) is opening up a new research field. A workshop from November 21 - 22, 2016 will mark the start of activities for an innovative axion experiment. Axions are still only purely hypothetical particles. Their detection could solve two fundamental problems in particle physics: What dark matter consists of and why it has not yet been possible to directly observe a CP violation for the strong interaction.
The “MADMAX” project is the MPP’s commitment to axion research. Axions are so far only a theoretical prediction and are difficult to detect: on the one hand,...
Broadband rotational spectroscopy unravels structural reshaping of isolated molecules in the gas phase to accommodate water
In two recent publications in the Journal of Chemical Physics and in the Journal of Physical Chemistry Letters, researchers around Melanie Schnell from the Max...
The efficiency of power electronic systems is not solely dependent on electrical efficiency but also on weight, for example, in mobile systems. When the weight of relevant components and devices in airplanes, for instance, is reduced, fuel savings can be achieved and correspondingly greenhouse gas emissions decreased. New materials and components based on gallium nitride (GaN) can help to reduce weight and increase the efficiency. With these new materials, power electronic switches can be operated at higher switching frequency, resulting in higher power density and lower material costs.
Researchers at the Fraunhofer Institute for Solar Energy Systems ISE together with partners have investigated how these materials can be used to make power...
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