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March 17, 2004
Commencement of Clinical trials for HGF Genetic Medicine in Japan
-The first multi-centered double-blind trial for genetic medicine in Japan- |
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AnGes MG has been preparing for the clinical
trials of its HGF genetic medicine in Japan. Today the administering
of this medicine to the first patient has commenced, initiating
the first multi-centered double-blind trial of HGF genetic
medicine for peripheral arterial disease (PAD) in Japan.
HGF genetic medicine has a neovascular effect and is intended
to cure ischemic disease in which the lumen of blood vessels
narrows due to arteriosclerosis and the blood flow is impaired.
Since this medicine has a unique effect differing from conventional
drugs, it is expected to be effective in patients who have not
responded to conventional drug therapy or in those where surgery
is not liable to improve the patient’s condition. HGF genetic
medicine is primarily intended PAD with decreased blood circulation
in the lower limbs (obstructive arteriosclerosis and Buerger
disease) or ischemic heart disease (IHD) with impaired cardiac
flow. AnGes MG has been working on the development of this medicine
in both fields.
The present clinical trial is to be performed as a multi-centered
phase lll trial to evaluate the efficacy of HGF genetic
medicine in patients with PAD, specifically with obstructive
arteriosclerosis presenting severe pain at rest or ischemic ulcer.
AnGes MG has already started phase ll trials of HGF
genetic medicine against PAD in the US. AnGes MG aims to develop
this medicine for PAD concurrently both in Japan and the USA.
AnGes MG has granted Daiichi Pharmaceutical Co., Ltd. the distribution
rights for HGF genetic medicine in both PAD and IHD treatment
in Japan, the US and Europe. |
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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. |
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