Gradiflow to play role in hep C project

Chronic hepatitis C patients at risk of liver failure, of cancer or the liver may take heart from a joint venture announced this week between Sydney company Life Therapeutics (formerly Gradipore) (ASX:GDP) -- and Italian blood-products company Kedrion, based in Naples.

Kedrion will use Life Therapeutics' patented Gradiflow electrophoresis technology to purify and concentrate antibodies to hepatitis C virus (HCV) from the serum of HCV-positive patients, for a US-based clinical trial in HCV patients.

Hepatitis C immune globulin (HCIV) was originally developed as an investigational new drug to prevent HCV re-infection in patients who have had liver transplants after suffering HCV-induced liver failure.

The virus flourishes in the presence of the powerful immuno-suppressant drugs used to prevent organ rejection, and re-infection is almost universal. Clinical trials have shown that HCIV therapy prevents re-infection in 93 per cent of patients.

Life Therapeutics' MD and CEO Dr Hari Nair said there was a significant, unsatisfied demand in the US and Italy for an HCIV therapy for patients in other stages of HCV infection.

Nair said HCIV would be the treatment of choice for the estimated 800,000 HCV-positive people in Italy, and 4 million HCV-positive Americans, because current treatments are effective in only 50 per cent of cases. HCV is estimated to cost the US economy alone US$3 billion annually, and the global market for an effective HCV therapeutic has been estimated at US$400 million.

Nair said Life Therapeutics' joint venture with Kedrion would provide his company with a European manufacturing and distribution node, as part of its strategy of becoming a niche therapeutics manufacturer.

The company's chief scientist, Dr Kai Ling Wang, said Gradflow technology had marked advantages over rival techniques such as cone fractionation for purifying therapeutic products from serum.

Rival techniques involve multiple steps, whereas Gradiflow technology separates and purifies proteins in a one-pass, high-throughput operation, that recovers at least 90 per cent of the target protein while simultaneously excluding viral pathogens.

Wang said Life Therapeutics had conducted extensive validation trials to confirm that Gradiflow eliminated a variety of model viruses. Single-pass fractionation and purification made for a relatively cheap and very safe product.

Nair said that, under the terms of their joint venture, Kedrion would use Gradiflow technology to extract the product at its state-of-the-art facility in Naples, from HCV-positive plasma provided by Life Therapeutics.

Kedrion is also develping hyperimmune globulin therapeutics for hepatitis B and D, and tetanus.