AMARILLO, Texas, July 19 /PRNewswire/ -- Amarillo Biosciences, Inc.
(Nasdaq: AMAR) today announced an agreement for a $3 million loan from
Hayashibara Biochemical Laboratories (HBL), its principal shareholder. The
loan will provide $1 million per quarter starting in August 1999 and will be
repayable upon the earlier of July 22, 2004 or 1 year after FDA approval is
obtained for the use of low dose oral interferon alpha for any indication.
These funds will be used for the Company's ongoing clinical trial programs.
Amarillo Biosciences is conducting a Phase III clinical trial using low
dose oral interferon alpha for the treatment of Sjogren's syndrome. This
study is being conducted at 50 sites within the United States, and calls for
the enrollment of a total of 500 patients. The study is being monitored by
PPD Development, Inc. Approximately 50% of the total number of patients
required for the study have been enrolled. The Company anticipates that the
study will be completed in the year 2000.
Sjogren's syndrome is characterized by dry eyes and dry mouth. Patients
experience significant discomfort and are susceptible to optical damage and
oral disease. The condition affects approximately one to two million
Americans, mostly women, according to the Sjogren's Syndrome Foundation.
Amarillo Biosciences initiated its Phase III clinical trial in November 1998
after the successful completion of a Phase II clinical trial. The results of
this study indicated that the use of oral interferon alpha significantly
increased stimulated salivary flow, improved mouth comfort, and decreased the
sensation of eye dryness in those patients who possessed a baseline tear and
saliva production capability.
The Company is also testing low dose oral interferon alpha in a multi-
center Phase II fibromyalgia clinical trial. Fibromyalgia is a syndrome
typified by musculoskeletal pain and tenderness, fatigue and, in some
instances, depression. Fibromyalgia affects between five and ten million
Americans; the largest percentage of whom are women.
The Company, in conjunction with its partner North China Pharmaceutical
Company, will be initiating a Phase III clinical trial using low dose oral
interferon alpha for the treatment of hepatitis B in China later this year.
Dr. Joseph M. Cummins, President and CEO, stated that the continued
support by Hayashibara Laboratories, Inc. is an invaluable asset. Hayashibara
Laboratories is, and continues to be, not only a partner but a valuable friend
of the Company. Hayashibara Biochemical Laboratories is a member the
Hayashibara Group, a 110 year old privately owned Japanese holding company
with diversified subsidiaries including pharmaceutical, food, and life science
divisions.
The Company believes that low dose oral interferon has numerous benefits
as compared to high dose injectable interferon, including milder side effects,
greater cost effectiveness and convenient oral dosing.
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 alpha 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
Dec. 31, 1998."
SOURCE Amarillo Biosciences, Inc.
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Related links:
http://www.amarbio.com
CONTACT:
Kathleen Kelleher, Chief Operating Officer
and Vice President Business Development of Amarillo Biosciences,
Inc., 806-376-1741 ext. 15, or email, kkelleher@amarbio.com
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