AMARILLO, TX -- 08/24/07 --
Amarillo Biosciences, Inc. (ABI) (OTCBB: AMAR)
today announced the following developments:
In Turkey, enrollment is 78% complete in a Phase 2 study of Behçet's
disease. In the United States, patients have been enrolled to date in a
Phase 2 clinical trial of oral warts. In Australia, a human influenza
study is planned in 2008. In Taiwan and China, ABI's Taiwanese partners
are expected to conduct a clinical trial in chronic active hepatitis C
patients. These developments will help pave the way for the realization of
the Company's ultimate goal: FDA approval for its low-dose oral interferon.
Behçet's Disease Double-blinded, Placebo-controlled Phase 2 Clinical Trial
Enrollment in Turkey for Behçet's disease currently stands at 70 patients.
Ninety patients are required in order to complete the Phase 2 clinical
trial. Enrollment is expected to be completed in the fall of 2007, and data
analysis will begin approximately 12 weeks after the last patient is
enrolled. The Company's Turkish partner Nobel Ilac, one of the largest
pharmaceutical companies in Turkey, is funding the study. Nobel Ilac may
be able to use the Phase 2 data to seek approval in Turkey, assuming the
data are compelling.
Oral Warts Double-blinded, Placebo-controlled Phase 2 Clinical Trial
Our Phase 2 clinical trial is testing low-dose interferon alpha lozenges
administered orally to subjects who have oral warts and are also positive
for human immunodeficiency virus (HIV). Viral lesions of the mouth in
patients infected with HIV are common and may be indicative of disease
progression. One of the causes of oral lesions is an oral infection with
the wart-producing papillomavirus.
Eight clinical sites in San Francisco, Baltimore, Chicago, New York City,
Boston, Philadelphia, Newark and Dallas are open for enrollment of patients
for this study. Four new sites in Lexington, San Antonio, Ft. Lauderdale
and Augusta are expected to begin enrollment in September 2007.
CytoPharm Plans for Hepatitis C Clinical Trial
The Company's licensee in Taiwan and China is CytoPharm, Inc., a Taipei,
Taiwan-based biopharmaceutical company whose parent company is Vita
Genomics, Inc., the largest biotech company in Taiwan specializing in
pharmacogenomics and specialty Clinical Research Organization. Both
CytoPharm and Vita Genomics are affiliates of Ho Tung Chemical Corp. Ltd.,
one of the largest petrochemical companies in Taiwan, and a publicly traded
company whose 2005 revenues exceeded NTD 35 billion.
Under the terms of the Agreement, between CytoPharm and ABI, CytoPharm and
its subsidiary will conduct and fund all clinical trials, and seek
regulatory approvals in both China and Taiwan (the Territory) to launch low
dose oral interferon for influenza, hepatitis B, and hepatitis C
indications. CytoPharm has entered into discussions with regulatory
agencies in the Territory to conduct their first clinical trial in 152
hepatitis C patients. The trial is expected to commence in late 2007 or
early 2008.
Texas Tech University Idiopathic Pulmonary Fibrosis and COPD Studies
Eighteen patients were enrolled in a pilot study of the use of interferon
lozenges in the treatment of idiopathic pulmonary fibrosis (IPF) at Texas
Tech University. Dr. Lutherer reported that more than half of his patients
treated for at least one year showed no signs of disease progression as
assessed by pulmonary-function testing and high-resolution CT scans of
their lungs. IPF is normally rapidly progressive, so the fact that half of
the patients have shown no progression of the disease during interferon
lozenge treatment is encouraging. These clinical results are being
submitted for publication to a major medical journal.
However, the most surprising observation from the IPF research is that
low-dose oral interferon relieves chronic coughing in patients with IPF.
Since chronic coughing is a major problem in Chronic Obstructive Pulmonary
Disease (COPD), a Phase 2 clinical study of oral interferon treatment of
chronic cough in COPD will begin in September 2007.
COPD is reported to affect 10% of humans over the age of 40. Because COPD
affects many millions of people and is not an Orphan Disease (a disease
that affects fewer than 200,000 people in the U.S.), the study of COPD
would require a large study population and is, therefore, too costly for
the Company to study beyond Phase 2 without a pharmaceutical partner. If
the clinical data from Phase 2 are as positive as expected, these Phase 2
data will be shared with potential pharma partners.
Federal Funding
Amarillo Biosciences retained Hance, Scarborough, Wright, Woodward &
Weisbart an Austin-based law firm to represent the Company regarding
federal governmental and private source funding for influenza studies. The
Company is working to obtain federal funding for clinical trials on
influenza to be conducted in 2008. University institutions such as the
Texas Tech University Health Sciences Center would conduct these trials.
Beyond these efforts to procure federal funding, the Company seeks investor
funding so that it can complete its clinical studies.
Influenza
Animal trials were conducted in 2006/2007 in Australia, USA and Germany.
An oral dose of interferon was found which protected mice against a fatal
influenza challenge. A human trial is planned in Perth, Australia in 2008.
Dr. Manfred Beilharz, the principal investigator, was in Amarillo this
month to work on the clinical protocol with staff from the Company.
About Amarillo Biosciences, Inc.
Amarillo Biosciences, Inc. is a U.S. biotechnology firm operating in global
partnership with the Hayashibara Group, which also holds 12% of Amarillo
Biosciences' shares and has provided over $17.9 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,
Behçet's disease, and opportunistic infections in patients who are HIV
positive. In its 23-year history, the company has invested nearly $38
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 company
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, 2006.
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
