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May 8, 2006
Results of the US Phase I Clinical Trials with HGF Gene Plasmid for
Ischemic Heart Disease (IHD) |
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AnGes MG, Inc. (AnGes) is pleased to announce that the Data Safety Monitoring
Board (DSMB) for the IHD indication reviewed the interim safety data (3 months)
and did not find any critical safety concerns in the US Phase I clinical trial.
HGF plasmid contains the gene for human Hepatocyte Growth Factor (HGF) which
has angiogenesis effect. It could be the treatment for ischemic disease which is
low blood flow caused by occlusion or narrowing of the vessels due to
arteriosclerosis. As this drug has a different mechanism from conventional drugs,
it expected to be effective for subjects who do not sufficiently respond to
conventional drug therapy or who are poor candidates for revascularization.
AnGes is developing HGF plasmid in subjects who have poor perfusion in the lower
limbs, this is known as Peripheral Arterial Disease (PAD) which includes
arteriosclerosis obliterans and Buerger’s disease, along with subjects with IHD, who
have poor perfusion in myocardium.
The primary objective of this Phase I clinical trial was to assess the safety of HGF
plasmid in subjects with IHD. In general, healthy volunteers are used for Phase I
studies to assess safety. However, as healthy volunteers are not appropriate to
assess safety particularly for anticancer drug and gene therapy, Phase I trials for
this kind of drugs are conducted using subjects with the target disease. In addition
to that, this study used an investigational endocardial injection catheter to
administer the HGF plasmid into the target ischemic lesion of myocardial. Thus nine
severe IHD patients were enrolled in this study.
AnGes has granted Daiichi Pharmaceutical Co., Ltd. the distribution rights for HGF
plasmid in both PAD and IHD indications in Japan, the US and Europe. |
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