Amarillo Biosciences (OTCBB: AMAR) made waves yesterday when it announced that two new clinical sites – one in New Jersey and one in Pennsylvania – would be ready to enroll new patients in a Phase 2 study on “a test of low-dose interferon alpha lozenges administered orally to HIV-positive subjects with oral warts.”While it may sound like a disgusting and trivial waste of manpower, the company’s Phase 2 tests are actually quite necessary. Viral lesions found in the mouths of HIV patients are common, painful, and are indicative of disease progression. According to the company’s press release, one of the causes of oral lesions is a group of DNA viruses known as human papilloma viruses, which induce lesions in the soft tissue in and around the mouth such as papillomas, warts, condylomata and focal epithelial hyperplasma.
“Oral warts cause a significant reduction in quality of life due to their deleterious effects on patient appearance and potential for causing discomfort during routine activities such as eating and talking,” the company said in the press release.
The press release went on to state that the rate of lesion recurrence was high, even if the warts and lesions were removed through cryosurgery, electrocoagulation, the use of a CO2 laser or through excision. Naturally, this makes it necessary to find an alternative method of removing the lesions.
According to the press release, the company’s proprietary interferon alpha lozenges showed they could “significantly reduce oral wart load in HIV-positive patients. Once the company can show the lozenges are safe and works, it plans on moving to a Phase 3 study before filing a New Drug Application and seeking marketing approval for its lozenges.
“Although anti-HIV drugs are quite helpful against most opportunistic infections in patients with HIV, the prevelance of papillomavirus, in the mouth and elsewhere, is increasing,” Amarillo’s President and CEO, Dr. Joseph M. Cummins, said in the release. “Our company’s mission is to obtain FDA approval for our low-dose oral interferon Alpha to treat oral warts and other diseases. This Phase 2 clinical study, in conjunction with our ongoing Phase 2 clinical study in Turkey on Behcet’s disease, [make for] two important steps in attaining our objective.”
