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November 22, 2005
Completion of Trial Subject Enrollment for U.S. Phase I Clinical Trial of HGF
Plasmid for Ischemic Heart Disease (IHD) |
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AnGes, Inc., the U.S. subsidiary of AnGes MG, Inc., launched a Phase I clinical trial of HGF plasmid in patients with ischemic heart disease (IHD) in November 2004. The enrollment of the ninth subject, the target number of subjects in the present trial, has now been completed. As soon as the evaluation period after administration to each subject is completed, the Company will perform data analyses and conclude evaluations of the results of the trial.
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 has 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 sufficiently respond to conventional drug therapy or who cannot undergo surgery. AnGes MG is developing HGF plasmid for indications related to peripheral arterial disease (PAD; arteriosclerosis obliterans and Buerger’s disease), in which blood circulation in the lower limbs is decreased, and for IHD, in which blood flow in the heart is impaired.
For the current pipeline of HGF plasmid in the U.S., AnGes completed the enrollment of subjects for the U.S. Phase II clinical trial in patients with PAD in May 2005, and now enrollment of subjects for the U.S. Phase I clinical trial in patients with IHD has also been completed. As soon as the evaluation period after administration to each subject is completed, the Company will perform data analyses and conclude evaluations on the results of both trials.
In Japan, AnGes MG is currently conducting PAD-related multi-center double-blind Phase III clinical trials, and in order to complete this clinical trial at an early date, AnGes MG is actively engaged in the promotion of subject enrollment.
AnGes MG has granted Daiichi Pharmaceutical Co., Ltd. the distribution rights for HGF plasmid in both PAD and IHD indications in Japan, the U.S. and Europe. |
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