Amarillo Biosciences, Inc. (OTCBB: AMAR) is the world leader in the development of low-dose interferon for oral delivery and has progressed to Phase 2 clinical studies using its unique, patented interferon lozenges to treat human diseases.
Low-dose oral interferon has been shown to prevent death in mice infected with H1N1 or H5N1 influenza viruses. The University of Western Australia completed a Phase 2 clinical trial with 200 healthy volunteers during the 2009 winter cold/flu season in Australia. The study found that volunteers who took oral interferon had less severe cold/flu symptoms, compared to volunteers who received placebo.
Follow-up studies are planned during the 2011/12 influenza season. In the US, patients in the third day of a confirmed influenza infection and moderate to severe fever and flu-like symptoms will be treated twice daily for 4 days to see if oral IFN can reduce the duration and severity of influenza illness, compared to placebo.
In Taiwan, 60 patients being treated with Tamiflu for influenza A infection of less than 48 hours’ duration will be randomly assigned to co-treatment with oral IFN or placebo. The aim of the study is to examine whether the combination of oral IFN and Tamiflu is superior to Taimflu alone in the treatment of influenza illness.
CytoPharm, Inc., AMAR’s licensee for Taiwan and China, is funding an ongoing Phase 2 study of oral interferon treatment of hepatitis C virus-infected patients. The study is expected to demonstrate the ability of oral interferon to reduce virologic relapse in patients who have completed standard therapy with pegylated interferon plus ribavirin. Up to 50% of patients with certain genotypes of HCV relapse after receiving standard therapy. Reducing this relapse rate will represent a major breakthrough in the management of HCV. Study results are expected in early 2012.
Technology: Non-toxic Interferon
Interferon is an immune modulator approved to treat some cancers, as well as viral and autoimmune diseases. AMAR has completed pre-clinical (animal trials) and human safety studies for its low-dose oral interferon product. The oral route of administration in humans uses a lozenge that is stable for up to 2 years at room temperature. Orally delivered interferon binds to mucosal cells in the mouth and throat, resulting in stimulation of the immune system through activation of hundreds of genes in the peripheral blood. Oral interferon is given in doses 10,000 times lower than injectable interferon, so side effects are virtually eliminated. AMAR owns or licenses 5 issued US patents related to this technology.
What is interferon?
Scientists discovered an antiviral protein in 1957 and named it “interferon” because it interfered with the growth of flu virus in chick embryos. In 1987, the FDA granted the first approval for injectable interferon to treat hairy cell leukemia. Since then, injectable interferon has gained FDA approval to treat various cancers, as well as several viral and autoimmune diseases.
The goal of AMAR
Based on its patented platform technology, the goal of the Company is to achieve FDA approval of its safe and effective low-dose oral formulation of human interferon alpha to treat multiple diseases. Phase 2 human studies are currently being conducted.
Maxisal®
Maxisal® is a dietary supplement for relief of mouth and throat dryness.
Maxisal® is a dietary supplement containing Salive®, a patented disaccharide called Anhydrous Crystalline Maltose. This unique maltose has been shown in clinical studies to relieve dryness of the mouth and throat.
Dry mouth is simply a nuisance for some people, for others, the condition can cause serious health problems such as oral infections; tooth decay; bad breath; altered taste sensation and difficulty in chewing, swallowing, and speaking. The major causes of dry mouth include:
- Over 400 prescription and other-the-counter drugs.
- Age-related deterioration of salivary function.
- Medical treatments such as head/neck radiotherapy.
- Autoimmune diseases such as Sjögren’s syndrome and Scleroderma.
At least 25 million people in the U.S. suffer with some form of dry mouth. People with this condition seek relief by increasing fluid intake, chewing sugarless gum or by sucking on sugarless lozenges. Maxisal® containing Salive® is a new solution to the problem. Maxisal® promotes oral comfort, helps promote normal salivary function, enhances salivary function and helps to relieve occasional dry mouth associated with aging.*
Clinical data indicate that Maxisal® improves the baseline production of saliva, known as unstimulated whole saliva, in many people experiencing dryness of the mouth. Until the discovery of Maxisal®, temporary relief from dry mouth could only be achieved while the candy or chewing gum was in the mouth, making nighttime relief difficult.
