Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

PowderMed’s therapeutic DNA vaccine for chronic hepatitis B enters phase I clinical trials in patients

30.03.2006
PowderMed, the immunotherapeutics company focused on the development and manufacture of DNA-based vaccines for viral diseases and cancer, has announced that its dual-antigen encoding immunotherapeutic for Hepatitis B (HBV) has received US IND approval together with approval from the Singapore, Hong Kong and Taiwanese Regulatory Authorities and has entered Phase I Clinical Trials.

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.

Susan Yu | alfa
Further information:
http://www.northbankcommunications.com
http://www.powdermed.com

More articles from Life Sciences:

nachricht Water forms 'spine of hydration' around DNA, group finds
26.05.2017 | Cornell University

nachricht How herpesviruses win the footrace against the immune system
26.05.2017 | Helmholtz-Zentrum für Infektionsforschung

All articles from Life Sciences >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Can the immune system be boosted against Staphylococcus aureus by delivery of messenger RNA?

Staphylococcus aureus is a feared pathogen (MRSA, multi-resistant S. aureus) due to frequent resistances against many antibiotics, especially in hospital infections. Researchers at the Paul-Ehrlich-Institut have identified immunological processes that prevent a successful immune response directed against the pathogenic agent. The delivery of bacterial proteins with RNA adjuvant or messenger RNA (mRNA) into immune cells allows the re-direction of the immune response towards an active defense against S. aureus. This could be of significant importance for the development of an effective vaccine. PLOS Pathogens has published these research results online on 25 May 2017.

Staphylococcus aureus (S. aureus) is a bacterium that colonizes by far more than half of the skin and the mucosa of adults, usually without causing infections....

Im Focus: A quantum walk of photons

Physicists from the University of Würzburg are capable of generating identical looking single light particles at the push of a button. Two new studies now demonstrate the potential this method holds.

The quantum computer has fuelled the imagination of scientists for decades: It is based on fundamentally different phenomena than a conventional computer....

Im Focus: Turmoil in sluggish electrons’ existence

An international team of physicists has monitored the scattering behaviour of electrons in a non-conducting material in real-time. Their insights could be beneficial for radiotherapy.

We can refer to electrons in non-conducting materials as ‘sluggish’. Typically, they remain fixed in a location, deep inside an atomic composite. It is hence...

Im Focus: Wafer-thin Magnetic Materials Developed for Future Quantum Technologies

Two-dimensional magnetic structures are regarded as a promising material for new types of data storage, since the magnetic properties of individual molecular building blocks can be investigated and modified. For the first time, researchers have now produced a wafer-thin ferrimagnet, in which molecules with different magnetic centers arrange themselves on a gold surface to form a checkerboard pattern. Scientists at the Swiss Nanoscience Institute at the University of Basel and the Paul Scherrer Institute published their findings in the journal Nature Communications.

Ferrimagnets are composed of two centers which are magnetized at different strengths and point in opposing directions. Two-dimensional, quasi-flat ferrimagnets...

Im Focus: World's thinnest hologram paves path to new 3-D world

Nano-hologram paves way for integration of 3-D holography into everyday electronics

An Australian-Chinese research team has created the world's thinnest hologram, paving the way towards the integration of 3D holography into everyday...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

Marine Conservation: IASS Contributes to UN Ocean Conference in New York on 5-9 June

24.05.2017 | Event News

AWK Aachen Machine Tool Colloquium 2017: Internet of Production for Agile Enterprises

23.05.2017 | Event News

Dortmund MST Conference presents Individualized Healthcare Solutions with micro and nanotechnology

22.05.2017 | Event News

 
Latest News

How herpesviruses win the footrace against the immune system

26.05.2017 | Life Sciences

Water forms 'spine of hydration' around DNA, group finds

26.05.2017 | Life Sciences

First Juno science results supported by University of Leicester's Jupiter 'forecast'

26.05.2017 | Physics and Astronomy

VideoLinks
B2B-VideoLinks
More VideoLinks >>>