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| |  FDA Grants Orphan Drug Status To Veldona (Interferon-Alpha) For Oral Warts In HIV-Positive Patients AMARILLO, TX -- August 23, 2000 -- Amarillo Biosciences, Inc. announces that its proprietary orally-administered interferon-alpha has been granted orphan drug designation as a treatment of papillomavirus warts in the oral cavity of HIV positive patients. Oral warts are severe, chronic, debilitating and disfiguring with no existing satisfactory treatment. Therapy consisting of surgery, freezing or cautery is only partially effective. In contrast, Amarillo Biosciences' low dose orally- administered interferon-alpha (Veldona®) has shown a preliminary indication of effectiveness with minimal side effects in an initial clinical trial in a major HIV treatment center in San Francisco. The oral formulation 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. The orphan designation process is the mechanism by which sponsors of drugs and biologics for rare diseases qualify for the tax credit and marketing exclusivity incentives of the Orphan Drug Act. The Office of Orphan Products Development also administers a clinical research grants program, whereby researchers may compete for funding to conduct clinical trials to support the approval of drugs for rare diseases. The US patient population with HIV and persistent oral warts has been estimated at less than 5,000. Amarillo Biosciences has been granted Orphan Drug status previously for orally-administered interferon alpha for the treatment of Behcet's disease and a meeting with FDA, regarding Behcet's disease, has been requested. Dr. Joseph M. Cummins, CEO of Amarillo Biosciences stated, "We believe that low dose orally-administered interferon-alpha has therapeutic benefit in oral warts with a virtual absence of side effects."
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