Shire licenses SPD-754 to Avexa

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Shire Pharmaceuticals announced yesterday that it has licensed its experimental nucleoside analogue SPD-754 to the Australian company Avexa, but will retain North American marketing rights.

Avexa is a Melbourne-based company with a focus on the development of new anti-infectives, and is already screening products to identify an HIV integrase inhibitor.

Avexa will now take the drug forward into phase IIb studies and anticipates that the drug could be licensed in 2009. Avexa said yesterday that the drug will be positioned as a second line treatment for patients who have developed resistance to 3TC (lamivudine). Avexa is preparing SPD754 to enter a Phase IIb trial designed to

Glossary

phase II

The second stage in the clinical evaluation of a new drug or intervention, in which preliminary data on effectiveness and additional information about safety is collected among a few hundred people with the disease or condition.

nucleoside

A precursor to a building block of DNA or RNA. Nucleosides must be chemically changed into nucleotides before they can be used to make DNA or RNA. 

toxicity

Side-effects.

placebo

A pill or liquid which looks and tastes exactly like a real drug, but contains no active substance.

mitochondrial toxicity

Mitochondria are structures in human cells responsible for energy production. When damaged by anti-HIV drugs, this can cause a wide range of side-effects, including possibly fat loss (lipoatrophy).

demonstrate its efficacy in HIV-infected patients who have resistance to therapy with 3TC (lamivudine), a first line HIV therapy.The Phase IIb trial will examine two different doses of SPD754 and compare the drug to 3TC. This trial will be conducted in Australia, with the first patient expected to be enrolled by the middle of this year and results due in the first quarter of 2006.

Research presented at the Second International AIDS Society conference in Paris in 2003 showed that SPD-754 reduced viral load in a placebo-controlled study by 1.65-1.8 log10 copies/ml, suggesting that the drug is a potent nucleoside analogue. The drug is active against 3TC and AZT-resistant virus in the test tube, and has demonstrated negligible mitochondrial toxicity in test tube studies.

For further information on SPD-754 click here.