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April 9, 2002
MedGene Bioscience, Inc.
Daiichi Pharmaceutical Co., Ltd.
AnGes MG
and Daiichi Pharmaceutical Entered into a Distribution
Agreement for HGF Gene Medicine in Japan, USA, and Europe |
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AnGes MG, Inc., Osaka, Japan (former name: MedGene
Bioscience, Inc.; President: Masanori Murayama) has agreed on
a distribution agreement with Daiichi Pharmaceutical Co., Ltd.,
Tokyo, Japan (President: Kiyoshi Morita) for a Hepatocyte Growth
Factor (HGF) gene medicine, an experimental HGF DNA drug product.
In January 2001, Daiichi Pharmaceutical acquired the exclusive
sales and marketing rights in Japan and for peripheral arterial
disease (PAD) indications. The new agreement allows Daiichi
to acquire the exclusive sales and marketing rights in USA and
Europe for PAD, and in Japan, USA, and Europe for coronary arterial
disease (CAD) indications.
This experimental drug employs a DNA sequence (HGF gene) that
produces HGF protein, having an angiogenic effect, and will
be the first gene-based drug for gene therapy being developed
in Japan. The HGF DNA injected into the ischemic tissues induces
the regeneration of blood vessels that bypass arterial obstructions,
thereby improving the blood flow. Through this mechanism, the
agent is expected to show an efficacy in the treatment of patients
with PAD (including arteriosclerotic obliteration and Buerger's
disease) and CAD (including angina pectoris and myocardial infarction).
Because the mechanism of action of this DNA therapy differs
from that of conventional pharmaceutical agents, it is anticipated
that HGF DNA treatment will be effective in patients for whom
existing pharmaceutical therapies are insufficient or for whom
surgery is not appropriate.
AnGes MG is a bioventure company established in December 1999
aiming to contribute to the human health through R&D of
gene-based agents for use in gene therapy, oligodeoxynucleotide
drug and a novel vector technology. In cooperation with domestic
and international research institutes including Osaka University,
AnGes MG strives to seek practical applications for basic technologies
that the University has developed in gene medicine. In October
2001, to initiate clinical trials in the international arena,
AnGes MG established a wholly owned subsidiary, AnGes, Inc.,
in Maryland, USA, and in May this year, the Company plans to
establish a subsidiary in Europe.
Daiichi regards the thrombosis and vascular disease area to
be of great importance for development of novel therapies and
commits itself to contribute to regenerative medicine internationally,
through the marketing of HGF gene medicine and support for development
of the agent operated by AnGes MG in Japan, USA, and Europe. |
| Reference |
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 Characteristics
and significance of HGF gene medicine for human gene therapy
HGF, first identified in Japan, is a potent angiogenic factor
with promise in the treatment of PAD and CAD. The HGF agent
will become a first gene therapy agent candidate originating
from Japan. Administration of the gene into the ischemic tissue
of the legs or heart of patients is expected to result in secretion
of HGF protein that will induce localized new blood vessel formation
and increase the blood flow in the affected tissue. This agent
employs naked DNA technology without using viral vector systems.
Thus, this technology avoids the adverse effects and potentially
serious events caused by viral vectors. The biological mechanism
of this gene transfer technology is distinctly different from
that of conventional pharmaceutical therapies. It is expected
to be a novel therapy and effective in patients with advanced
PAD and CAD who do not respond to currently known therapies.
Glossary
1. Gene medicine
An agent that contains gene(s) or a part of gene that carries
the DNA code for protein(s) with therapeutic benefits.
2. Hepatocyte Growth Factor (HGF)
A growth factor identified as the most potent growth factor
of hepatocytes, and plays important roles in angiogenesis, organogenesis
in embryonic development, and the regeneration of tissues and
organs damaged by a various forms of injury.
3. Peripheral arterial disease (PAD)
Narrowing and occlusion of peripheral arteries resulting in
ischemia of muscle and skin, manifested by numbness, coldness,
difficulty of walking (claudication), rest pain, and formation
of ischemic ulcers. PAD includes arteriosclerotic obliteration
and Buerger's disease.
4.
Coronary arterial disease (CAD)
Partial or complete blockage of coronary arteries nourishing
the heart resulting in reduced supply of blood needed for the
blood pumping action of the heart. CAD is manifested as angina
pectoris, chest discomfort and chest pain caused by myocardial
ischemia, and myocardial infarction caused by complete occlusion
of a coronary artery.
5.
Naked DNA
For gene expression of its protein, DNA must enter into
cells. Expression does not occur with simple adherence to the
cell surface. Generally, vector (vehicle) systems including
recombinant viruses or liposomes containing therapeutic genes
are used in gene transfer technologies. The HGF gene medicine
employs a plasmid carrying the HGF gene as naked DNA. Usefulness
of the naked DNA (gene) delivery technology is depending upon
application routes to the body. Following direct intramuscular
administration of the naked DNA into skeletal or heart muscles,
the gene enters the cells of the tissue and enables expression
of sufficient protein to induce therapeutic effects. This technology
is considered safe because it does not result in infection and
cell damage as observed with the use of viral vector or liposome
gene transfer technologies. |
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