SOURCE: Amarillo Biosciences, Inc.

May 04, 2006 17:30 ET

Amarillo Biosciences Schedules Annual Meeting and Issues Progress Report

AMARILLO, TX -- (MARKET WIRE) -- May 4, 2006 -- Amarillo Biosciences, Inc. (ABI) (OTC BB: AMAR), today announced its annual shareholder's meeting will be held June 22, 2006 in Amarillo, Texas at the Days Inn, East 1701 E IH40 starting at 10 am. The proxy material was submitted to the SEC for review last week. At the shareholder's meeting, the following corporate developments will be discussed:

ABI Supports Two Animal Influenza Studies

ABI is currently conducting two animal studies in influenza. The world-renowned Trudeau Institute in Saranac Lake, New York, recently completed a pilot study that indicated that mice, given a low-dose of interferon intranasally, lost significantly (P < 0.01) less weight after inoculation with mouse-adapted influenza virus. (Weight loss is a key indicator of a successful therapeutic agent in animal influenza studies.) As a result, ABI is sponsoring a second, expanded study at the Trudeau Institute. This study is ongoing and should be completed by late May 2006. Concurrently, ABI is sponsoring another influenza study in mice, which is being conducted by Manfred Beilharz, PhD, the Head of Microbiology and Immunology, School of Biomedical, Biomolecular and Chemical Sciences, The University of Western Australia. Dr. Beilharz and members of his research department have 10 publications and 3 dissertations on the subject of orally administered interferon. Dr. Beilharz is the past President of the Australian Interferon Society and an internationally recognized authority on interferon. This study is also expected to be completed by late May 2006. Furthermore, ABI is planning to launch influenza studies in poultry by the end of May.

"It is our goal to generate animal data to support the human data from clinical trials in the former Soviet Union, Bulgaria, Japan and China. In those studies, it was reported that orally or intranasally administered interferon significantly (P < 0.05) reduced the severity and duration of naturally occurring influenza, compared to placebo. With new animal data to supplement the historical human data, we hope to insert oral interferon into the debate as to how best to respond to an influenza pandemic," said Dr. Joseph Cummins, President and CEO, ABI.

ABI Partner Global Kinetics Receives Notification of Cambodian Approval of Low Dose Oral Interferon

Global Kinetics, ABI's licensee, notified ABI that the company's oral interferon, to be marketed under the name VELDONA, has been approved for sale by the Cambodian Ministry of Health. ABI expects, as indicated by the Cambodian Ministry of Health, to receive a provisional certificate to import VELDONA into Cambodia in the near future. Following receipt of the importation certification, Global Kinetics expects to receive a significant purchase order that will be transferred to ABI for fulfillment. In addition, Global Kinetics expects that this approval will result in corresponding approvals in Laos and Vietnam, the other territories it has licensed from ABI.

ABI Bolsters Board of Directors, Management and retains Teel Bivins to Represent Company's Interest on Avian Influenza and National Security Matters

ABI has nominated Thomas D'Alonzo, Former President, Glaxo, Inc., and Thomas Ulie, CEO, First Island Capital, to its Board of Directors; their nominations will be formally voted on at the company's annual meeting. The company also strengthened its management with the appointment of Gary Coy as its CFO. Dr. Coy, who has a PhD degree (Chemistry) and an MBA, has over thirty years of business experience and successfully led a laboratory testing company from start-up to sale. The proposed new board members and appointment of Gary Coy as CFO are intended to assist the company in accessing the equity capital markets. ABI recently retained the consulting services of Teel Bivins, former Ambassador to Sweden. Mr. Bivins has been active in Texas politics for many years and served as a member of the Texas State Senate where he held many senior leadership posts. Mr. Bivins is expected to help ABI gain acceptance for ABI's technology to treat influenza and to help control foot-and-mouth disease.

Enrollment in Turkish Behcet's Disease Has Commenced

Nobel Ilac Sanayii Ve Ticaret A.S., a leading Turkish pharmaceutical company, which is co-sponsoring a Behcet's Disease study with ABI, has confirmed that enrollment of 90 patients with Behcet's disease has commenced. Fourteen patients have already been screened and five have been started on treatment as of today's date. The double blind Phase II Study will test the efficacy of interferon lozenges versus placebo. The treatment duration is 12 weeks, with completion of the study expected within a year.

Enrollment Underway at M.D. Anderson Cancer Study

Patients are currently being enrolled in a study at M.D. Anderson Cancer Center in Houston, Texas, to evaluate interferon lozenges in patients with the pre-leukemic conditions known as essential thrombocythemia and polycythemia vera. The first stage of enrollment should be completed by August. Goal of the study is to support and expand on positive data ABI generated in treating these conditions at the Mayo Clinic.

Orphan Drug Designation Granted to ABI by The FDA

The FDA has granted Orphan Drug Designations (ODDs) to ABI for oral warts in HIV+ patients, Behcet's Disease and polycythemia vera (PV). FDA grants ODDs for diseases that affect fewer than 200,000 patients in the U.S. Benefits of ODDs to the Company are: a) seven years' exclusivity in the marketplace; b) tax credits equal to 50% of clinical trial costs; and c) possible exemption from FDA user fees. The annual US and European market potential for these 3 diseases is estimated at over $600 million.

Enrollment Completed in Texas Tech University Health Sciences Center Idiopathic Pulmonary Fibrosis Study

Enrollment has been completed in an ongoing study of the use of interferon lozenges in treatment of idiopathic pulmonary fibrosis (IPF) at Texas Tech University Health Sciences Center in Lubbock, Texas (TTUHSC). The principal investigator, Lorenz Lutherer, MD, PhD, presented current findings from the study at the Southern Regional Meeting of the Society for Clinical Investigations on March 3 in Atlanta, Georgia. Dr. Lutherer has noted benefits in a number of patients and is urging ABI to follow up this pilot study of 18 patients with a larger, controlled study. Of particular note has been the almost total elimination of the persistent coughing reported by many patients at baseline. IPF is normally rapidly progressive, so the fact that at least half the patients have shown no progression of their disease during interferon lozenge treatment is very encouraging. Dr. Lutherer will report to the shareholders on the excellent progress of his patients.

ABI Applies for Additional Patent Protection for its Low Dose Oral Interferon

ABI filed a new patent application with claims that low-dose natural human interferon is a therapeutic agent against chronic coughing. Recent findings from the TTUHSC IPF study and long-term observation on relief of cough in Sjogren's syndrome indicate that oral interferon provides substantial benefits in reducing chronic coughing.

ABI Partner Dr. Claus Martin in Discussions with South American Pharma Companies

Dr. Claus Martin, President and CEO of Gesellschaft Fur Medizinisch and Technische Investionen mbH & CoKG (GMTI mbH &CoKG), a privately held German venture capital group with which ABI has an agency agreement to commercialize natural human interferon, has been holding discussions with leading national pharmaceutical companies in Argentina, Uruguay and Brazil to discuss ABI's low-dose oral interferon as a possible therapy for avian flu, hepatitis, dengue fever and AIDS.

About Amarillo Biosciences, Inc.

Amarillo Biosciences, Inc. is a U.S. biotechnology firm operating in global partnership with the Hayashibara Group, which also holds 15.5% of Amarillo Biosciences shares and has provided over $17.8 million in loans, grants and equity investments. The Company's primary focus is extensive and ongoing R&D into the use of low-dose, orally administered interferon as a treatment for a variety of conditions, including Sjogren's syndrome, Behcet's disease, and opportunistic infections in patients who are HIV positive. In its 21-year history, ABI has invested nearly $37 million to establish oral interferon as a therapeutic agent. The majority of those funds were invested in clinical trials in an effort to achieve FDA approval for interferon. Additional information is available on the ABI web site at http://www.amarbio.com/.

Except for the historical information contained herein, the matters discussed in this news release are forward-looking statements that involve risks and uncertainties, including uncertainties related to product development, uncertainties related to the need for regulatory and other government approvals, dependence on proprietary technology, uncertainty of market acceptance of oral interferon or the Company's other product candidates and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission. In particular, see "Item 1. Description of Business" of the Company's Form 10-KSB for the year ended December 31, 2005.

Contact Information

  • Investor Relations:
    Philippe Niemetz
    PAN Consultants, Ltd.
    e-mail:p.niemetz@panconsultants.com
    Tel: 800-477-7570; 212-344-6464
    Fax: 212-618-1276

    Joseph M. Cummins, DVM, PhD
    Amarillo Biosciences, Inc.
    e-mail:jcummins@amarbio.com
    Tel: 806-376-1741 x 13
    Fax: 806-376-9301