FDA CLEARS AMARILLO BIOSCIENCES LOW-DOSE ORAL INTERFERON STUDY

Amarillo Biosciences announced it has resolved all clinical and safety issues with the FDA and is ready to initiate a study with a leading Turkish pharmaceutical company, Nobel Ilac Sanayii Ve Ticaret.

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

Low-dose orally administered interferon-alpha is administered as a lozenge, which is allowed to dissolve slowly in the mouth. Oral dosing with interferon-alpha has a number of advantages over the injectable form. In addition to substantially fewer side effects, the lozenge is more convenient, cost-effective and does not require refrigerated storage. ABI's product has received orphan-drug status from the FDA.