Amarillo to start Turkish trial of oral INF

Amarillo Biosciences says that it has resolved all clinical and safety issues with the US Food and Drug Administration and is ready to initiate a study of oral interferon alpha with a leading Turkish pharmaceutical company, Nobel Ilac Sanayii ve Ticaret AS.

The trial is expected to commence in October and to be completed within a year. Amarillo's oral, low-dose interferon-alpha will be tested as a treatment for Behcet's disease in 90 Turkish patients. Nobel Ilac has a license to the product in Azerbaijan, Bosnia and Herzegovina, Bulgaria, Croatia, Georgia, Kazakhstan, Kyrgyzstan, Macedonia, Romania, Russia, Saudi Arabia, Slovenia, Tajikistan, Turkmenistan, Turkey, Uzbekistan and the Federal Republic of Yugoslavia.

In Turkey, the incidence of Behcet's disease as a percentage of the population is 600 times more common than in the USA, which was a crucial factor in choosing the country as the site of the trial. This rare autoimmune disorder that is characterized by mouth ulcers and generally two additional symptoms such as recurrent genital ulceration, eye or skin lesions or a positive pathergy (skin) test, is currently incurable with no existing satisfactory treatment.