AMARILLO, Texas, July 17 /PRNewswire/ -- Amarillo Biosciences, Inc.
(OTC Bulletin Board: AMAR.OB) announces a supplemental analysis of the
Company's second Phase II clinical trial in patients with fibromyalgia
syndrome (FMS), a disorder which affects 5-8 million people in the United
States. FMS patients characteristically suffer from pain, stiffness and
depression, which often leave the patient disabled.
The Phase II clinical trial was a double-blinded, placebo-controlled study
in which 119 FMS patients were treated once or three times daily with lozenges
containing 50 International Units (IU) of natural human interferon (IFN) alpha
or with a placebo for 12 weeks.
Exhaustive regression analysis of the Phase II data, a rigorous review of
all possible combinations of factors, discovered a difference in response
between patients who had an injury (a car accident, for example) which
contributed to the development of their FMS and those patients without a
history of injury (prior injury is recognized as an important factor by
rheumatologists). In this supplemental analysis of the 82 patients in this
study who did not report a past injury as a causative factor in their FMS, the
group given a single 50 IU IFN alpha lozenge daily experienced significantly
(P<0.05) greater improvement, compared to the placebo group, in 5 important
variables, including 1) morning stiffness severity, the primary endpoint in
the study, 2) time to maximum morning stiffness improvement, 3) "badness" of
general stiffness, 4) general stiffness severity over the past week, and
5) morning stiffness severity now compared to baseline. In 8 other variables,
including 3 measures of pain, 50 IU IFN alpha treatment led to greater, though
non-significant, improvement compared to placebo.
About 2/3 of FMS patients do not have an injury as a causative factor in
their history. Consequently, the population who might respond to oral IFN
alpha is probably over 3-5 million. There is no FDA-approved therapy for FMS,
so most patients are treated with pain and/or anti-depression medication.
The difference in response between patients with and without history of an
injury was uncovered during the supplemental analysis of the clinical trial
data using a statistical technique made possible by recent technological
advancements in distributed computing. Exhaustive Regression, developed by
Parabon Computation, Inc. of Fairfax, Virginia, takes advantage of the massive
computation made possible by the Frontier distributed computing platform to
search all possible combinations of factors for models that are statistically
significant.
A US patent on the use of oral IFN alpha to treat fibromyalgia issued in
March 2000 to the Company. "Since we have now completed two Phase II clinical
trials with a total of 231 fibromyalgia patients, and because the data from
the two studies point to a daily dose of 50 IU as benefitting patients, we are
eager to raise funds to tackle a Phase III trial of IFN alpha in this
important condition for which we have patent protection," said Dr. Joseph M.
Cummins, President and CEO for Amarillo Biosciences. The Company plans to
discuss these new findings, in addition to the overall results of both Phase
II clinical studies, with the FDA. The Company has already collected safety
data on more than 1500 patients treated in blinded, controlled studies. "In
general, adverse event reports in our studies are just as common in placebo-
treated patients as they are in patients given oral interferon," said
Dr. Cummins.
Amarillo Biosciences, founded in 1984, is a pioneer in the research of low
dose orally-administered interferon alpha as a treatment for a variety of
conditions including Sjogren's syndrome, fibromyalgia syndrome, Behcet's
disease, hepatitis B and C, and opportunistic infections in patients who are
HIV positive.
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
December 31, 2000.
SOURCE Amarillo Biosciences, Inc.
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Related links:
http://www.amarbio.com
Company News On-Call:
http://www.prnewswire.com/gh/cnoc/comp/118055.html
CONTACT:
Joseph M. Cummins, President & CEO of
Amarillo Biosciences, Inc., +1-806-376-1741 ext. #13, or
jcummins@amarbio.com
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