January 4, 2007
Dear Shareholder,
The year 2006 was a milestone for ABI and set the
stage for an even more significant year in 2007. In the past
year, ABI laid the groundwork to conduct a series of clinical trials
on four continents in 2007.
In Turkey, ABI began enrollment for our Behçet’s'™
disease study. In the United States, we are in the final stages
of site registration for a six-city Phase 2 clinical trial on oral
warts in AIDS patients. In Australia, a human influenza study
is planned in mid-2007. In Taiwan and China, we look forward to
clinical trials for chronic active hepatitis B and human influenza
later this year. These developments, in conjunction with a number
of other ongoing studies in humans and animals, will pave the way for
the realization of our ultimate objective: FDA approval for our 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 50 patients. We must reach 90 patients
to complete the Phase 2 clinical trial. Enrollment is expected
to be completed in the first or second quarter of 2007, and data analysis
will begin approximately 12 weeks after the last patient is enrolled.
Our 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 will test low-dose interferon
alpha lozenges administered orally to subjects who have oral warts
and are also positive for human immunodeficiency virus (HIV) virus.
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 the DNA virus, human papillomavirus, which induces
hyperplastic lesions in the oral soft tissue such as warts and focal
epithelial hyperplasia. We
have already registered five clinical sites in San Francisco, Chicago,
New York City, Boston, and Dallas for this study. A site in Baltimore
is expected to register in January and all sites are expected to begin
enrollment in January 2007.
CytoPharm Licensing and Supply Agreement, Hepatitis B
and Human Influenza Clinical Trials for Taiwan and China
Approximately a month ago, ABI entered into a License and Supply Agreement
with 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, CytoPharm and
its subsidiary will conduct all clinical trials, and seek regulatory
approvals in both China and Taiwan (the Territory) to launch ABI's™
low dose oral interferon for influenza and hepatitis B indications. CytoPharm
has entered into discussions with regulatory agencies in the Territory
to conduct clinical trials, which are expected to commence in 2007.
Texas Tech University Idiopathic Pulmonary Fibrosis and
COPD Studies
Eighteen patients completed a pilot study of the
use of interferon lozenges in the treatment of idiopathic pulmonary
fibrosis (IPF) at Texas Tech University. As previously announced,
the principal investigator, Lorenz Lutherer presented findings from
the study at the Company's annual shareholders meeting. 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.
However, the most surprising observation from our
research is that low-dose oral interferon relieves chronic coughing
in patients with IPF or Sjögren'™s syndrome. Moreover,
ABI has published that horses with chronic obstructive pulmonary
disease or COPD, also called inflammatory airway disease, are significantly
improved with low doses of oral interferon. Coughing, a component
of COPD in horses is relieved by oral interferon.
An SBIR grant was submitted to NIH in November in cooperation with
Dr. Lutherer. If funded, this grant application will allow the Company
to conduct a pilot study to verify that oral interferon stops chronic
coughing.
Two new patent applications were filed in 2006. One of these new patent
applications contained claims on the use of oral interferon to relieve
chronic coughing. The other new application pertained to animal health.
COPD Initiative
ABI is seeking funding to treat chronic coughing in human COPD or
IPF patients with oral interferon. 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 expensive for ABI 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
ABI retained Hance, Scarborough, Wright, Woodward & Weisbart an
Austin-based law firm to represent ABI regarding federal governmental and
private source funding for influenza studies. In 2007, we
will be aggressively working on obtaining federal funding
for clinical trials to be conducted in 2007 and 2008. Beyond federal
funding, ABI is seeking investor funding so we can complete all our
clinical studies.
Consultant agreement with Claus Martin, MD
Dr. Martin has helped ABI by introducing companies India, South America
and SE Asia. Through Dr. Martin efforts, ABI was able to enter a License
and Supply Agreement in Malaysia with Bumimedic.
Influenza
Animal trials were conducted in 2006 in Australia, New York and Nebraska.
An oral dose of interferon was found which protected mice against a
fatal influenza challenge. Animal research will continue in 2007 in
Australia and New York. Human trials, as mentioned above, are expected
in Australia, Taiwan, and China.
Dietary Supplement
In December 2006, Hayashibara Biochemical Laboratories granted ABI
a 5-year extension of our Supply Agreement for anhydrous crystalline
maltose (ACM). The company sells ACM as Maxisal to individuals and
to pharmacies for the patented relief of dry mouth (xerostomia). The
Company plans to license Maxisal to a distributor for nationwide sales
in 2007.
Best wishes to our 2000 shareholders. We will work to add value
to the shareholders' investment in the coming year.
Sincerely,
Joseph M. Cummins, DVM, PhD
President and CEO
Joseph M. Cummins, DVM, PhD Amarillo Biosciences, Inc.
e-mail:jcummins@amarbio.com
Tel:806-376-1741 x 13
Fax:806-376-9301
Philippe Niemetz WPH Consultants, Ltd.
e-mail:philippe.niemetz@wphconsultants.com
Tel:800-477-7570; 212-344-6464
Fax:212-618-1276
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