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December 2, 2003
AnGes MG
receives green light from the Japanese Ministry of Health
for its clinical trials for HGF genetic medicine
-Japan's first large-scale multi-centered
double-blind clinical trials
for genetic medicine underway- |
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AnGes MG submitted the formal application for
its planned large-scale multi-centered double-blind clinical
trials for genetic medicine to treat peripheral arterial diseases
(PAD) to the Japanese Ministry of Health, Labor and Welfare
on October 31, 2003, and has now received the ministry's confirmation.
The company is thus going to be the first Japanese enterprise
to embark on large-scale multi-centered double-blind clinical
trials of genetic medicine. It will be concluding agreements
with medical institutions where the clinical trials are to be
performed.
The HGF genetic medicine regenerates the blood vessels to improve
the condition of patients with clogged capillaries due to arteriosclerosis
or similar blood circulation disorders. Application of the medicine,
currently under development, is principally different from all
conventional drugs, as it enables effective treatment in cases
when general pharmacological therapy is insufficient, and where
surgery may not improve the patient's condition. AnGes MG is
developing medication mainly to treat PAD patients with progressing
blood circulation disorders of the lower extremities (arteriosclerosis
obliterans, Buerger's disease), as well as those with progressing
ischemic heart disease (IHD) affecting the blood circulation
in the heart (angina pectoris, myocardial infarction).
AnGes is planning multi-centered studies related to domestic
clinical trials of HGF genetic medicine for PAD, specifically,
for patients with arteriosclerosis obliterans suffering pain
even at rest or ischemic ulcer, or those with Buerger's disease
with ischemic ulcer. The present large-scale multi-centered
double-blind clinical trials is to be performed to verify efficacy
as a Phase III study.
For the HGF genetic medicine for PAD, Phase II studies are underway
in the U.S., and AnGes MG is aiming at joint development both
in Japan and the U.S.
Marketing / distribution rights for the HGF medicine in Japan,
Europe and the U.S., for both PAD and IHD, have been granted
to Daiichi Seiyaku (Daiichi Pharmaceutical) Co., Ltd. |
| Reference |
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 Specific
therapeutic significance of the HGF genetic medicine
It is known that HGF has a strong vascularization effect; the
present pharmaceutical agent deposits a gene to produce HGF
in sites of vascular necrosis, thus the HGF protein is generated
locally, resulting in blood vessel regeneration to improve the
(arteriosclerotic) condition - the first genetic medication
to be produced in Japan. The agent thus developed does not employ
a virus vector to introduce the genetic sequence to a patient's
DNA - it is a pure, "naked" DNA sequence, so negative
effects that usually accompany a DNA sequence introduction with
a virus vector do not appear here. In addition, since the present
medicine alters the condition of necrosis by regenerating the
blood vessels, as opposed to all conventional pharmaceutical
agents, positive results can be expected in cases when conventional
therapy for PAD and IHD fails, or is increasingly complicated.
Explanation
of specialized terms
1. Gene medicine
A medicine, wholly, or partially comprising a genetic expression.
2. Hepatocyte Growth Factor (HGF)
A growth factor developed from hepatocytes; in addition to blood
vessel regeneration, it initiates various processes necessary
for tissue / organ regeneration during organ formation (organogenesis).
3. Peripheral arterial disease (PAD)
Since peripheral blood vessels of the four limbs can become
clogged, so that the supply of blood to muscle and skin tissues
is not adversely affected, causing the following symptoms: a
feeling of paralysis, coldness, arrest of blood flow (intermittent
claudication), ulcer of lower limbs (thrombic disease), pain
even when there is no motion. A condition characteristic of
arteriosclerosis obliterans (ASO), Buerger's disease. There
are approximately 100,000 patients in Japan and 1,000,000 -
in the U.S.A.
4. Ischemic heart disease (IHD)
Vessels supplying the heart (coronary blood vessels) become
contracted (or constricted) to a certain extent resulting in
insufficient blood flow after physical activity; characteristic
symptoms are angina pectoris accompanied with a tightness in
the chest and chest pains, and myocardial infarction causes
by disorders of coronary blood vessels becoming completely clogged
- heart muscle tissue becoming ischemic. There are approximately
100,000 patients in Japan who underwent angioplasty surgery
due to severe heart disease, and 1.8 million - in the U.S.
5. Naked DNA
For a genetic expression to work properly, genes have
to enter a cell; in conventional practice, however, genes may
only come as close as to be attached to the cell membrane, unable
to penetrate it. A carrier, an agent to introduce the genetic
expression to a cell, becomes necessary at this point. An improved
virus vector (i.e., purified not to pose danger to the host
cell) is usually used for these purposes, and the method features
a genetic expression introduced to a cell by a ribosome. Our
methodology of the HGF genetic medication, by contrast, has
genes spiraling in "plasmid DNA" (a naked DNA technology).
Plasmid DNA alone may not be able to penetrate the cell membrane,
it can, however, generate genes if injected intra-muscularly.
The technology is extremely safe with no danger of contamination
and cytotoxicity due to ribosomes or viruses. |
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