Sydney, Australia Amrad Corporation Ltd. raised A$15.5 million (US$7.9 million) from institutional investors in part to finance a Phase II trial of a compound for treating chronic severe pain, after also announcing a successful Phase I/II trial of the compound.
Amrad, of Melbourne, said last week it achieved positive results from the Phase I/II trial of AM336, conducted with a small number of terminally ill cancer patients at investigating centers in Melbourne, Sydney and Brisbane.
The company has yet to release results from the study, but Amrad Managing Director Sandra Webb said the majority of patients elected to continue to receive the drug at the end of the 12-day study period. The results were sufficiently encouraging for the company to finish the study earlier than planned.
“This tells us that AM336 can be safely administered at doses required to provide pain relief,” she said. “These early findings are showing that AM336 has the potential to treat one of the most distressing symptoms of cancer: the pain.”
Webb told BioWorld International the initial trials were both Phase I and Phase II because the company was required to test AM336 initially on terminally ill patients.
“We were forced into that end of the patient population,” she said.
The company now plans bulkier Phase II trials, a portion of which may be conducted in the much larger U.S. patient population, but no decisions have been made about the design of the trial.
Webb said that the company had a pre-investigational new drug meeting with the FDA at the end of March, and plans to take its lead from discussions with the FDA.
Also last week, Amrad announced that it sold 13.5 million shares at A$1.15 a share to institutional investors to help pay for its development program, including seven projects in clinical and preclinical stages.
AM336 is a synthetic version of a molecule originally isolated from the venom of a fish-eating species of cone snail found in Australia’s Great Barrier Reef. The company said the molecule blocks pain in the spine and acts in a completely different way from narcotic analgesics and morphine commonly used to treat severe cancer pain.
Amrad’s share price, which has been falling since reaching a peak of $1.50 around mid-February, was not helped by the announcement, dropping another A$0.02 on Feb. 25 to close at A$1.12.