| |
 |
 |
 |
 |
 |
 |
 |
December 2, 2002
Investigational
New Drug (IND) application filed
with the USFDA for HGF genetic medicine |
 |
|
|
AnGes Inc., the U.S. subsidiary of AnGes MG Incorporated,
submitted the IND application to the FDA to be able to perform
second phase of HGF genetic medicine clinical trials with PAD
patients (suffering from arteriosclerosis obliterans). This
is the first time for a Japanese company to perform clinical
trials for a genetic medicine in the U.S.
The HGF genetic medicine regenerates the blood vessels to improve
the condition of patients with alveoli clogged due to arteriosclerosis
and similar blood circulation disorders. Application of the
present medicine is principally different from all conventional
drugs, enabling effective treatment in cases when general pharmacological
therapy is insufficient, but surgery might not improve a patient's
condition. We are developing medication mainly to treat PAD
patients with progressing blood circulation disorders of lower
limbs (arteriosclerosis obliterans, Buerger's disease), as well
as those with progressing arteriosclerosis affecting blood circulation
in the heart (ischemic heart disease, myocardial disorders).
The present application to FDA shall enable us to proceed with
clinical trials in the U.S., where their second phase will be
conducted, since we have already conducted clinical research
in this regard at the Osaka University.
Marketing / distribution of the HGF genetic medicine for both
PAD and CAD will be handled by Daiichi SeiYaku (Daiichi Pharmaceutical)
Co., Ltd. |
| Reference |
|
|
|
 Specific
therapeutic significance of the HGF genetic medicine
It is known that HGF has a strong vascularization effect; the
present pharmacological 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 re-generating the
blood vessels, as opposed to all conventional pharmacological
agents, positive results can be expected in cases when conventional
therapy for PAD and CAD 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, 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.
4. Ischemic heart diseases
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 of stenocardic chest pains and a tightness in the chest,
disorders of coronary blood vessels becoming completely clogged
- heart muscle tissue becomes ischemic.
5. Pure (or "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 (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 through a ribosome. Our methodology
of the HGF genetic medication, by contrast, has genes spiraling
in "plasmidic DNA" (a naked DNA technology). Plasmidic
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. |
|
|
