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Amarillo Biosciences, Inc. (ABI) is a public company working to bring low-dose oral interferon products to your pharmacy.  Interferon, an antiviral protein, was discovered 50 years ago when researchers noticed a substance interfering with the growth of influenza virus in chicken embryos.  Scientists isolated the substance – and, because of its “interfering” properties, named it interferon.

However, interferon is not just an antiviral protein. It is now recognized as a key component of the human immune system.  Not only does interferon act to trigger, amplify and sustain different phases of human immune response, but it also seems to promote a balance between infections and an inflammatory response during the recovery phase – i.e., when an infection is either declining or ending.  Depending on dosage, interferon can either boost the immune system or suppress the immune system, so it is called an immune modulator. 

Twenty years ago, administration of high doses of interferon by injection was approved by the FDA as a treatment for hairy cell leukemia.  Since then, injectable interferon has been approved for use in treatment of other kinds of cancer, hepatitis B, hepatitis C and genital warts.  A form of interferon has also been approved to treat multiple sclerosis, an autoimmune disease.  However, despite the benefits of injectable interferon, many patients cannot tolerate the severe side effects of the high-dose injections, so they discontinue therapy.

ABI’s technology uses low-dose oral administration of interferon, not high-dose injectable interferon. Tiny amounts of interferon are placed in contact with the oral-pharyngeal mucosa (the lining of the mouth and throat), which activates beneficial systemic effects, not just a topical effect. ABI thus allows patients to receive all the benefits of interferon therapy, but without the toxicity of high-dose injections.

Tiny amounts of interferon are naturally produced in human nasal secretions and trickle down the throat to activate an immune response.  If a virus, rickettsia, chlamydia or mycoplasma is inhaled, the tissue of the nose responds by producing tiny amounts of interferon in the nasal secretions. This sends a message to the immune system, which says, “Hey, what you just inhaled is worthy of an immune response; it wasn’t just dust or pollen.   What was inhaled induced interferon, so a systemic immune response is needed.”

ABI did its first testing of oral interferon in dogs with parvovirus, cats with feline leukemia and cattle with shipping fever (or bovine respiratory disease).  Follow-up studies have been conducted in swine, horses, poultry, rats, mice – and now humans.

The Company is conducting human clinical trials in two diseases – known as  “Orphan Diseases” because they affect fewer than 200,000 patients.  Big pharmaceutical companies generally will not work on small-market diseases, so the U.S. government offers incentives to companies to work on Orphan Diseases.  Amarillo Biosciences has been granted Orphan-Disease Designation by the FDA for oral warts in HIV+ patients and for Behçet’s disease. This means the Company will enjoy seven years of exclusivity in the marketplace once its interferon treatment methodology achieves FDA approval.

Oral warts are caused by papillomavirus and can be a functional as well as cosmetic problem for patients who are HIV positive.  ABI is currently enrolling patients in a Phase 2 study at clinics in San Francisco, Chicago, New York City, Boston, Baltimore and Dallas, with additional sites opening soon in Philadelphia, Newark, N.J., and South Florida.  If you or anyone you know in those areas suffers from HIV-related oral warts, ABI would like to hear from you.

The Phase 2 study of Behçet’s disease is being conducted in Istanbul, Turkey, but under FDA paperwork and a U.S. Investigational New Drug (IND) application.  Behçet’s disease is rare in North America, but quite common in Turkey, so ABI is using foreign data to obtain FDA approval.  So far, 62 of the desired 90 patients have been enrolled, and sign-ups should accelerate with the addition of two new Turkish clinical sites in May. Current plans call for the study to be completed and data analyzed before year-end 2007.

Another human autoimmune disease that seems to respond well to oral interferon is idiopathic pulmonary fibrosis (IPF).  For five years, ABI has worked with Dr. Lawrence Lutherer at Texas Tech University.  He enrolled 18 IPF patients, and the response to oral interferon has been quite dramatic.  Some of the IPF patients have been stabilized, meaning they have not shown disease progression, and almost all the IPF patients who suffered with chronic cough have experienced relief.

Besides these human studies, some important animal studies are also ongoing.  Low-dose oral interferon protects mice against a fatal infection with influenza virus.  Mice are the animal model used by the U.S. government to evaluate testing of the efficacy of drugs against flu in humans.  ABI will soon be sharing animal data from Australia, Europe and the U.S. with government research facilities in an effort to motivate them to consider oral interferon as a preventative treatment for influenza.

The Company believes the world is currently quite vulnerable to influenza in spite of the use of vaccine and antiviral drugs such as neuraminidase inhibitors, and that a global influenza pandemic could kill millions of people if alternative therapies aren’t developed.

This is an exciting time for ABI, which plans to share additional news about ongoing Company developments with its shareholders at the Annual Meeting, scheduled for 7 p.m. on Friday, June 1, at the Ambassador Hotel, 3100 I-40 West, in Amarillo, Texas.