SYDNEY, Australia ¿ Amrad Corp. Ltd. will shortly put two products into Phase I trials ¿ a potential treatment for severe pain and one for hepatitis B viral infection.

Amrad, of Melbourne, said last week it received approval from the Australian Therapeutic Goods Adminis tration (the government body regulating drug trials) for the two trials to occur in hospitals in Adelaide, Sydney and Melbourne.

Amrad Managing Director John Grace said that the details of both still are being decided, but each will involve up to 12 people, with the first trial ¿ with a product called AM365 for HBV infection ¿ due to start in early April.

Grace said the second trial, of a product called AM336 for severe pain uncontrollable by existing therapies, is expected to start ¿closer to May.¿ But since there are ethical problems in giving a powerful analgesic to healthy volunteers, AM336 will be given to patients. As a result the trial will be a mixture of Phase I and Phase IIa, Grace said.

Amrad expects the results of both trials to be available in the third quarter. Grace said the compounds have performed well in animal and laboratory tests.

AM336 is a synthetic form of a naturally occurring compound originally identified in the venom of a fish-eating marine cone snail collected from the major Australian natural feature, the Great Barrier Reef off the coast of the State of Queensland.

AM365 was discovered as part of a collaborative project involving both Amrad and a government research department, the Commonwealth Scientific and Industrial Research Organization Division of Molecular Science. Hepatitis B virus infection can lead to fatal liver disease.

Amrad already has one compound in clinical trials, a treatment for nerve damage experienced by patients undergoing chemotherapy. It entered Phase II trials in September.

The company also announced its results for the half year to December, posting an after-tax loss of A$16.6 million (US$11.1 million) on total revenues of A$88.4, most of which came from the company¿s operations in health care products. Amrad lost almost A$6 million net by selling sections of the company during the half, as part of a restructuring announced last year (see BioWorld International, May 12, 1999). It also spent A$13.2 million on research and development.

Amrad also recently announced that it had licensed certain rights to another molecule it had been developing, to Ares-Serono International, of Geneva, Switzerland in a deal potentially worth up to US$16million. (See BioWorld International, Feb. 2, 2000.)