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July 12, 2004
| The U.S.
Food and Drug Administration (FDA) has given the go-ahead
for a clinical trial investigating AnGes' HGF plasmid
for the treatment of ischemic heart disease (IHD). This U.S.
study will be the first clinical investigation of HGF plasmid
for IHD. |
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As announced on February 26, 2004, AnGes Inc.
(a U.S. subsidiary of AnGes MG) submitted an Investigational
New Drug (IND) application for a Phase I study of HGF plasmid
in IHD. Today, AnGes MG announces receiving notification by
the FDA on July 9, 2004 that the study is cleared to proceed.
AnGes, Inc. (study sponsor) anticipates beginning the trial
in the near future.
HGF plasmid contains the gene for human hepatocyte growth factor
(HGF), which has the ability to generate the growth of new
blood vessels. This neovascular effect is intended to alleviate
ischemic disease, in which the lumen of the blood vessel is
narrowed, due to arteriosclerosis, and blood flow in the heart
is impaired. As this gene medicine operates in a different
manner than conventional drugs, it is expected to be effective
for people who do not respond to conventional drug therapy
or who cannot undergo surgery.
The primary objective of Phase I trials is to evaluate the
safety of the investigational medicine. Healthy volunteers
are often used as subjects in these trials, however, for gene
medicines for which it is deemed inappropriate from a safety
standpoint to administer them to normal, healthy individuals,
Phase I trials are conducted using subjects with the target
disease. In the IHD Phase I trial HGF plasmid will be administered
directly to ischemic cardiac muscle using an endomyocardial
catheter. The safety and preliminary efficacy of this treatment
will be evaluated in approximately ten subjects. AnGes MG is
also making preparations for a phase I IHD trial in Japan.
AnGes MG is also developing HGF plasmid for indications related
to PAD, in which blood circulation in the lower limbs is decreased
(critical leg ischemia, obstructive arteriosclerosis and Buerger's
disease). AnGes MG is currently conducting two PAD-related
multi-center, double blind Phase III clinical trials in Japan.
AnGes Inc. is currently conducting a U.S. Phase ll clinical
trial using HGF plasmid for the treatment of peripheral arterial
disease (PAD). AnGes MG intends to market HGF plasmid as a
gene medicine for both PAD and IHD in Japan, the U.S., and
Europe. AnGes MG has granted Daiichi Pharmaceutical Co., Ltd.
the distribution rights for HGF plasmid in both the PAD and
IHD indications in Japan, the USA, and Europe.
| Current
Pipeline for HGF Plasmid Therapeutic Agents |
| Field |
Region |
Development Phase |
Licensee |
| Peripheral arterial disease |
Japan |
Phase III |
Daiichi Pharmaceutical Co., Ltd. |
| USA |
Phase II |
| Ischemic
heart disease |
USA |
Phase I |
| Parkinson's
disease |
|
Pre-clinical level |
Undecided |
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