SYDNEY — Australian biotechnology company Amrad Corp. Ltd. completed the first Phase I trial of its potential motor neuron disease treatment, AM424, with none of the healthy subjects involved showing any side effects from the compound.
The company also said it will support further work on the use of AM424 combined with cochlear implants being studied by the Bionic Ear Institute, in Melbourne.
Amrad Finance Director Michael Rowland said the Phase I trial result was "excellent" and the company plans another Phase I trial, this time with patients, before proceeding with the Phase II trial.
He said the second Phase I trial is still being planned and he could not give any further details.
As previously reported, the just-completed trial was run in Britain and involved 28 healthy volunteers injected with doses of 0.05 to 32 mcg/kg, with the therapeutic dose likely to be set at 10 mcg/kg. (See BioWorld International, Oct 22, 1997, p. 3.)
Drug Discovered By Melbourne Scientists
At the time, company executives commented that if all went well with the Phase I trial, a Phase II trial would be held in the second or third quarter of 1998.
AM424 is the pharmaceutical form of the growth factor known as leukemia inhibitory factor, discovered at the Walter and Eliza Hall Institute of Medical Research and patented by Amrad.
The most likely target for AM424 is treatment of motor neuron disease, a fatal illness characterized by a gradual and relentless death of the patient's motor neurons and muscle wasting.
In July 1997, Amrad also said it was sponsoring work on the use of cochlear implants combined with AM424 as a means of reversing auditory cell death and improving current treatment for deafness. The cochlear implants already have proved to be an Australian medical success story, used to improve hearing in patients around the world.
Last week the company said the research project at the Bionic Ear Institute, in conjunction with the Human Communication Research Centre and the Walter and Eliza Hall Institute, all of Melbourne, has shown promise at the laboratory stage. Rowland said the amount of funding involved was not substantial.