Hem Pharmaceuticals Corp. of Philadelphia announced that itsinvestigational RNA therapeutic for treating chronic fatiguesyndrome will be distributed to Canadian patients through anexpanded-access program set up to allow patients with seriousor life-threatening diseases to receive promising newtreatments prior to marketing approval.
The Canadian Health Protection Branch has also given approvalto Hem to start its controlled Phase II/III clinical trials of thedrug Ampligen in Canada. The FDA approved U.S. Phase II/IIItrials for Ampligen in October.
"We are very enthusiastic about the opportunity of conductingPhase II/III trials of Ampligen throughout North America,enabling us to assess in a large patient population theeffectiveness of our investigational RNA therapeutic for anti-viral applications," said Nigel Webb, president of HemPharmaceuticals.
Ampligen is the synthetic double-stranded RNA compound PolyI: Poly C12U. This RNA therapeutic is believed to act in twoways: by switching on enzymes that are critical to anti-viraldefense mechanisms and by regulating the level of immunesystem modulators.
Although the exact cause of chronic fatigue syndrome, ormyalgic encephalomyelitis, is unknown, the illness is associatedwith exposure to herpes virus 6 and immunological disorders.It affects more than 100,000 people in North America andoften last for from six months to years.
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