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January 8, 2003
IND application
approved for HGF genetic medicine
treating peripheral arterial diseases |
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Our U.S. subsidiary submitted an IND (Investigational
New Drug) application for HGF genetic medicine treating peripheral
arterial diseases (ASO) to begin clinical trials - it was approved
by the U.S. F.D.A. Our group is thus going to be the first Japanese
enterprise to perform clinical trials 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, while 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 approval by the FDA is the permission to conduct
the second phase of clinical trials with PAD (ASO) patients
as (in principle) the clinical research with human subjects
has already been conducted at the Osaka University. We are thus
proceeding with the second phase of our clinical trials in the
U.S.
Marketing / distribution of the HGF genetic medicine in Japan,
Europe and the U.S. for both, PAD and CAD, will be handled by
DaiIchi SeiYaku (Dai Ichi Pharmaceutical) Co., Ltd. |
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