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Amarillo seeks FDA approval for lung trial

US-based biotech firm Amarillo Biosciences has submitted an investigational new drug application to the FDA seeking approval to begin a study of orally delivered interferon alpha in 60 patients with idiopathic pulmonary fibrosis.

These patients will be enrolled from approximately six clinical sites in the US and given interferon or placebo for four weeks to assess the effect of treatment on chronic cough.

According to the company, approximately 85-90% of idiopathic pulmonary fibrosis (IPF) patients complain of a bothersome persistent cough that negatively impacts their quality of life.

This trial is a follow-up to a positive pilot study conducted by investigators at the Texas Tech University Health Sciences Center, in which five out of six IPF patients given orally administered IFN-alpha reported a significant reduction in chronic cough with corresponding improvement in their quality of life.

Separately, the company is funding an influenza chicken study with Benchmark BioLabs of Lincoln, Nebraska. The new study will determine the effectiveness of oral interferon alpha against influenza in chickens.

“It makes sense to put interferon in the water of birds with influenza to reduce the amount of influenza virus excretion and thereby reduce the threat of infection to human personnel responsible for killing and disposing of infected birds,” said Joseph Cummins, CEO of Amarillo Biosciences.