Privately held HEM Pharmaceuticals of Philadelphia announcedthat the Canadian Health Protection Branch (CHPB) hasapproved an expanded access program for Ampligen, itsdouble-stranded RNA drug.
This will allow up to 200 eligible patients with renal cellcarcinoma (RCC) to receive treatments of the experimental drugprior to its approval for marketing.
Ampligen is the synthetic compound Poly I: Poly C12U. Thistherapeutic is thought to act in two ways: by regulating thelevel of immune system modulators and, as an anti-viral, byswitching on enzymes that are critical to anti-viral defensemechanisms in cells.
HEM Pharmaceuticals is "in the midst of a Phase II clinical trialin the U.S. on Ampligen for treating RCC," explained MaryannCharlap, company vice chairman, but hasn't initiated clinicaltrials for this indication in Canada yet.
However, the company is already testing Ampligen's potentialas an anti-viral in both Canadian and U.S. trials for treatingpatients suffering from chronic fatigue syndrome, which isassociated with exposure to herpes virus 6 and immunologicaldisorders.
The Canadian authorities have also granted patients expandedaccess to Ampligen for this indication. -- Jennifer Van Brunt
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