SYDNEY - Amrad Corp. Ltd. suspended a clinical trial of a reformulation of the fast-acting injectable anesthetic propofol after healthy volunteers developed adverse reactions, including irritation around the injection sites.
Amrad's managing director, John Grace, said the bioequivalence trials were suspended pending investigation of the data.
“The result of the trial is unexpected for Amrad and our partner, RTP Pharma Inc.,“ Grace said. “Despite the potential advantages of AM149, there was always the low possibility of this type of result, which highlights the risk inherent in the business of innovative pharmaceutical research and development.“
He also noted that Amrad, of Melbourne, Australia, has nine other compounds in clinical or preclinical trials - and so has a “rich“ development portfolio.
Amrad had expected to register AM149 in Europe next year and then in the U.S. As the compound is essentially an adaptation of an existing drug - with lower lipid concentration and improved bacterial resistance - extensive trials were not required for its registration.
Amrad licensed the patent rights to AM149 from RTP Pharma, of Montreal.
Amrad's share price has been falling since a temporary high of A$2.20 on Aug. 7, thanks to the generally soft Australian market, and was not helped by the announcement.
Just before disclosure of the trial suspension last week the company's stock was at A$1.70. It closed at A$1.58 Monday. - Mark Lawson
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