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October 10, 2002
| Announcement
regarding newspaper reports |
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Some newspapers yesterday reported that the Ministry
of Health, Labor and Welfare decided to partially suspend genetic
medication. This followed the decisions by France's national
health agency and the FDA in the United States to suspend similar
therapies. It has been confirmed that leukemia might have been
the result of such therapies in some of the patients who received
treatment with the alike genes.
As stated in our release of October 7, the genetic medication
to be suspended involves the use of genetic vector (recombinant
retrovirus vector) made from the leukemia virus found in mice.
Since we usually inject safe annular genes (plasmides) directly,
AnGES MD HGF genetic medication is excluded from the list of
the Ministry of Health, Labor and Welfare.
Our company will continue to develop HGF genetic medications
as planned. We have received a letter from the Recombinant DNA
Advisory Committee (RAC) of the United States National Institute
of Health (NIH) stating that it unanimously agrees with planned
applications for phase 2 clinical trials in late September 2002.
Therefore, we are planning to make an application to the FDA
for phase 2 of our clinical trials. In Japan, preparation is
proceeding toward the start of clinical trials in 2003. |
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