Physicians at Southern Health have started a phase IIa clinical trial designed to test the efficacy of a new strategy for defeating hepatitis C viral infection, one of the toughest infectious diseases in the modern world.

Implicit Bioscience's drug, oglufanide disodium, which works as a regulator of the body's immune response, is being given by intranasal administration to patients with chronic hepatitis C viral infection.

"The drugs currently in use fail to control this disease in about one half of all patients," said Dr Ian Frazer, Implicit's Chief Scientific Officer. "So there is a compelling need for new and better therapies, and we hope that oglufanide disodium may control or reverse the suppression of the immune system which the hepatitis virus uses to defeat our normally healthy defenses."

Dr Frazer is well known as the co-inventor of the recently approved vaccine for papillomavirus, which is designed to prevent cervical cancer.

Dr William Sievert, who is the Principal Investigator for the trial, welcomed the opportunity to study the action of oglufanide disodium in his busy liver diseases clinic at the Monash Medical Centre, which is part of the Southern Health network. "It is an important opportunity for patients to be involved in a new trial such as this, in which new treatment prospects are explored."

Oglufanide disodium was originally developed to treat severe infectious disease in Russia (where it is a registered pharmaceutical), and was extensively studied in cancer clinical trials in the United States before being acquired by the privately-owned Brisbane biotech company Implicit Bioscience Pty Ltd in 2005.

The phase IIa trial of intranasal oglufanide disodium will complement the ongoing phase Ib study of subcutaneously administered drug at the Princess Alexandra Hospital in Brisbane.

Oglufanide disodium regulates the body's innate immune response to defeat invading germs and cancer cells. The drug is also under development by Implicit as a biodefense therapy and for ovarian cancer.

Implicit Bioscience, Inc.
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