Interferon alpha is an anti-viral protein produced in the body that alters the function of the immune system, Cummins said. Delivery of the protein by oral lozenges has been Amarillo Biosciences' core business since the company was founded in 1984. Cummins said he has a three-pronged plan to get approval by the Food and Drug Administration. One route to FDA approval is the treatment of oral warts in HIV patients, he said. The FDA granted orphan-drug status for the treatment last year.
Orphan drugs treat conditions that affect very few people.
The designation gives certain benefits, including tax credits and marketing exclusivity. The company conducted a clinical trial in San Francisco that produced good results, Cummins said. Amarillo Biosciences had put the research on the backburner because of a lack of additional patients. But Cummins said when the company presented its data at the American Association of Dental Research in Chicago in March, it was approached by a dentist who offered it 150 HIV patients in Houston with oral warts. On the second front, Cummins said he plans to seek approval for treating Behcet's Disease, a condition that causes inflammation of the vessels in the eyes, the brain and the gastrointestinal tract, along with oral and genital ulcers.