The pharmaceutical company Targeted Genetics Corp has declared a renewal of the clinical tests interrupted in July of experimental genetic & therapeutic preparation for treatment of a rheumatoid arthritis.
Management on products and medicines of the USA (FDA) has given out the sanction for continuation of researches after careful studying of the condition of 127 volunteers, who have accepted a preparation.
The research has been curtailed after sudden death of the 36-year woman who has died in some weeks after introduction of the next doze of a medicine. In opinion of the experts, the death could be caused by unforeseen reaction to a virus, containing a preparation which was used as a carrier of a genetic material.
Nevertheless, during the investigation of the incident, the the reason of death of the patient has been recognized the fungoid infection which was not in any way connected with participation in the experiment of the woman that has died. The commission of FDA and the own experts of the company have come to such conclusion independently from each other has come. Besides the tested medicine the woman had accepted antiretrovirus and antimicrobial preparations, which, probably, could weaken its immune system.
The final results of the investigation will be made by the commission of National institute of public health services of the USA in December. However, according to the American laws, the pharmaceutical companies have the right to renew clinical tests irrespective of recommendations of this establishment.