Found this on a brows for news, anybody heard about this?
http://www.freshnews.com/news/biotech-biomedical/article_39288.html
Inovio Biomedical Partner Tripep Receives Approval to Initiate Phase I/
II Study of Novel Vaccine for Hepatitis C Virus
Inovio Biomedical Corporation (AMEX:INO), a leader in enabling the
development of DNA vaccines using electroporation-based DNA delivery,
announced today that its partner, Tripep AB of Sweden, received
approvals from the Swedish Medical Products Agency and local ethics
committees to initiate a Phase I/II clinical trial of a novel DNA
vaccine designed to treat chronically infected hepatitis C virus (HCV)
patients. The trial will test Tripep's proprietary DNA vaccine,
ChronVac-C , administered using Inovio's MedPulser DNA Delivery
System, in 12 subjects already infected with HCV. The trial will be
conducted in Sweden at two Karolinska University Hospitals, the Center
for Gastroenterology in Solana and the Infections Clinic in Huddinge,
beginning in October 2007.
"This is the first human study in the world in which a DNA vaccine
against an infectious disease is being administered by in vivo
electroporation. This technology has worked out very well in all
animal models that have been evaluated and we are happy that after
only 18 months of collaboration with Inovio we are able to start
clinical studies in humans," said Tripep's CEO, Jan Nilsson.
"Initiation of Tripep's hepatitis C DNA vaccine trial will mark our
fifth partnered clinical trial using Inovio's proprietary non-viral
DNA delivery technology," stated Dr. Avtar Dhillon, Inovio's president
and CEO. "We are pleased to be working with investigators at the world-
renowned Karolinska Institute to test this novel approach to treat
hepatitis C infections, which are responsible for a large number of
liver cancers each year."
About Inovio's Immunotherapy Products
DNA-based immunotherapies including DNA vaccines have the potential
to by-pass inherent scientific obstacles of conventional vaccines that
prevent their development for cancer and chronic infectious diseases
such as HIV and hepatitis C. Pre-clinical data has indicated the
ability of Inovio's technologies to effectively deliver and
significantly enhance the potency of such immunotherapies without the
potential safety concerns of viral systems.
Inovio's DNA-based immunotherapy products consist of DNA plasmids
and the Elgen and MedPulser DNA delivery systems. DNA plasmids are
designed to express antigens that can induce an immune response
specific to a cancer or infectious disease-causing organism. These
plasmids are created synthetically and readily manufactured using well-
established bacterial fermentation and purification technology. After
a plasmid is delivered into muscle or tumor cells, production of the
desired antigens may induce a preventive or therapeutic immune
response against the intended disease. Inovio's advanced
electroporation devices facilitate delivery and expression of these
plasmid DNA-based immunotherapeutics and have in primate studies and/
or interim Phase I data significantly enhanced antibody and T-cell
immune responses relative to plasmid DNA delivered by other methods,
suggesting the potential to provide better protective or therapeutic
effects against complex infectious diseases and cancers.
Inovio is poised to deliver advanced DNA-based immunotherapies,
devices and know-how in this rapidly advancing field. The company is
actively licensing its technology to pharmaceutical and biotechnology
companies and supporting early stage clinical studies arising from its
own research efforts or through academic collaborations.
About Hepatitis C and ChronVac-C
Hepatitis is a disease characterized by inflammation of the liver.
Hepatitis C virus (HCV) is a major cause of acute hepatitis. HCV is
spread primarily by direct contact with human blood, the major causes
worldwide being the use of unscreened blood transfusions and re-use of
inadequately sterilized needles and syringes. As many as 70% - 90% of
newly infected patients may progress to develop chronic infection
(WHO: 2002). Of those with chronic liver disease, 5% - 20% may develop
cirrhosis. About 5% of infected persons may die from the consequences
of long term infection (due to liver cancer or cirrhosis). Globally,
an estimated 170 million people are chronically infected with HCV,
which represents a reservoir sufficiently large for HCV to persist,
and 3 to 4 million persons are newly infected each year. In the US,
while new incidences of HCV have dropped dramatically, an estimated
4.1 million (1.6%) Americans have been infected with HCV, of whom 3.2
million are chronically infected (Centers for Disease Control and
Prevention: 2006).
HCV infections in the liver do not trigger an immune response very
effectively. Certain antiviral therapies, while expensive, are
somewhat effective in treating hepatitis C, but there is no vaccine
currently available to prevent hepatitis C. ChronVac-C is designed to
be a therapeutic DNA vaccine that can stimulate the body's immune
system. Animal experiments have demonstrated that ChronVac-C
vaccination activated B-cells and T-cells (the latter being regarded
as the most significant to clearing the chronic infection relating to
hepatitis C) that killed cells producing HCV protein. In humans, the
ChronVac-C DNA plasmid will be injected into muscle tissue, where
vaccinations are usually given, and taken up by muscle cells with the
assistance of Inovio's electroporation-based DNA delivery system.
These muscle cells would be expected to then produce predetermined
proteins that may activate the body's immune system to attack all
cells producing HCV proteins.
About Tripep AB
Tripep AB is a Swedish biotechnology research company that develops
and commercializes candidate drugs based on patented and proprietary
technologies. Its main focuses are research and clinical development
of ChronVac-C, a therapeutic vaccine against hepatitis C; preclinical
research focusing on the development of therapeutic and prophylactic
vaccines against influenza A and HIV; and the RAS technology platform.
More information is available at www.tripep.se. Contact Jan Nilsson,
CEO, at +46 8 449 8480 or jan.nilsson@tripep.se.
About Inovio Biomedical Corporation
Inovio Biomedical (AMEX: INO) is focused on developing multiple DNA-
based immunotherapies and commercializing its Selective
Electrochemical Tumor Ablation (SECTA) therapy. Inovio is a leader in
developing human applications of electroporation, using brief,
controlled electrical pulses to increase cellular uptake of a useful
biopharmaceutical. Interim human data has shown that Inovio's DNA
delivery technology can significantly increase gene expression and
immune responses from DNA vaccines. Immunotherapy partners include
Merck, Wyeth, Vical, University of Southampton, Moffitt Cancer Center,
the U.S. Army, National Cancer Institute, and International Aids
Vaccine Initiative. The SECTA therapy for locally treating solid
tumors is designed to selectively kill cancerous cells and minimize
cosmetic or functional detriments often caused by surgical removal of
predominantly healthy tissue typically treated around a tumor.
Inovio's technology is protected by an extensive patent portfolio
covering in vivo electroporation. More information is available at
www.inovio.com.
greyhackles - 27 Aug 2007 23:49 GMT
>Found this on a brows for news, anybody heard about this?
>
>http://www.freshnews.com/news/biotech-biomedical/article_39288.html
>
>Inovio Biomedical Partner Tripep Receives Approval to Initiate Phase I/
>II Study of Novel Vaccine for Hepatitis C Virus
[...]
Well, it's certainly a novel approach :-) and we can all hope they are highly
successful.
There are no small animal models for HCV, and the best large animal model -
chimpanzees - don't match up very well with the human model, plus there's a
humanistic argument against using chimps for drug research, anyway. So one
wonders exactly what pre-phase 1 testing they might have accomplished.
And HCV readily mutates when pressured. Assuming the mechanics of the therapy
work as described, will the HCV virions mutate so that the protein they
produce is different enough from what the therapy is using as the key?
Time will tell...
Cheers
/greyhackles
h00hbt - 28 Aug 2007 08:45 GMT
Hi greyhackles
This is all i can find at the moment and i used systran for
translating to english......however, there seems to be big bucks in
the marketing of the company behind ChronVac-C?, so one never
knows........
Take care
/H
New dates show that ChronVac-C? combined with Inovios Medpulser? DDS
gives equally good immunsvar in bigger animals that in mouse
During the ongoing toxicitetsstudierna of Tripeps ChronVac-C? vaccin,
administered with the aid of Inovios Medpulser? DDS, has new analyses
shown that the combination activates one antikroppssvar in rabbit that
is equally strong as they Tripep earlier seen in mouse studies. This
knowledge is of big value in the continued clinical development of
ChronVac-C?, then DNA-vaccin often functions poorer in bigger animals
than in small.
"this bodes goodly in order to ChronVac-C? administered with
Medpulser? DDS will can to function well also in people and that our
cooperation with Inovio is developed in correct direction" says
Tripeps CEO Jan Nilsson.
"we are pleased with the positive results from the studies and Tripeps
continued commitments with the development of this DNA-vaccin, with
the objective to start clinical studies with Inovios Medpulser? DDS"
states subsides Dhillon, MD, Inovios CEO.
For more information about Inovio is referred to the company's
homepage:
www.inovio.com.
For additional information v?nligen contact:
Jan Nilsson, CEO, Tripep Ltd
Tel.: +46 8 449 84 80, mobile: +46 70 466 31 63
E-mails: jan.nilsson@tripep.se
Anders Vahlne, research manager, Tripep Ltd
Tel.: +46 8 5858 1313, mobile: +46 709 28 05 28
E-mails: anders.vahlne@ki.se
Tripep is a cinema technical research company that develops and
commercializes l?kemedelskandidater - patented and patent applied for
technologies. The company focusses on the following areas:
- research and development of ChronVac-C?, a therapeutic vaccin
against Hepatit C.
- preklinisk research focused on development of therapeutic and
prophylactic
vacciner
- the technology stand RAS?.
For description of the company's technologies is referred to the
company's homepage www.tripep.se
> >Found this on a brows for news, anybody heard about this?
>
[quoted text clipped - 22 lines]
>
> /greyhackles