AMARILLO, Texas, March 9 /PRNewswire/ -- A just-completed Phase II
clinical study conducted by Amarillo Biosciences, Inc.
(OTC Bulletin Board: AMAR), has shown promising results for sufferers of
fibromyalgia syndrome. Fibromyalgia is a syndrome characterized by achy pain
and stiffness in the soft tissues, including the muscles, tendons and
ligaments. The three-month study, involving 89 patients at four clinical
sites around the United States, was designed to measure the effectiveness of
low doses of orally administered interferon-alpha (IFN alpha) in relieving
morning stiffness of joints, a significant problem for fibromyalgia sufferers.
The double-blinded, placebo-controlled test was the second in a series of
trials that, if successful, would lead to U.S. Food & Drug Administration
(FDA) approval of the new treatment regimen. Patients participating in the
study were divided into three groups, and each individual was given three
lozenges per day. The three lozenges given to members of the first group
contained 50 international units (IU) of IFN alpha each, while the second
group was given one 50 IU IFN alpha lozenge and two placebos. Members of the
final group received three placebos. All three groups reported a reduction in
morning stiffness, but across the entire study, the improvement was most
pronounced in those taking one 50 IU lozenge of IFN alpha per day. However,
the result did not reach statistical significance relative to the controls,
nor did increasing the dosage to three IFN alpha lozenges per day improve the
results.
All 89 participants were also given a low dose of the anti-depressant
drug, amitriptyline, which they began taking one month prior to the start of
the IFN alpha trial and continued throughout the three-month study. Dr.
Philip C. Fox, Director of Research and Development for Amarillo Biosciences,
said addition of the amitriptyline was deemed necessary so the patients would
not have to tolerate a four-month period without therapy. However, he also
noted that use of the amitriptyline complicated the analysis and
interpretation of the study results.
"In an effort to isolate the effects of the amitriptyline on the stiffness
results, we looked at the responses of patients during the first month of the
study, when they were receiving only amitriptyline," said Dr. Fox. "Patients
who did not worsen during the first month's treatment with amitriptyline went
on to demonstrate a significant reduction in morning stiffness (p=0.0035) when
they took the 50-IU IFN alpha lozenges once a day for three months compared
with a placebo. However, those patients who reported worsening of their
morning stiffness during the first month showed no benefit during the
subsequent three months of IFN alpha treatment."
The reduction in morning stiffness found in this study was consistent with
results from an earlier six-week blinded trial except this test showed a more
positive response in the placebo-treated group. (Note: It is well documented
in such studies that patients taking placebos tend to report at least some
improvement even though they are receiving no active drug.) Interestingly,
though, this "placebo effect" varied significantly from site to site. At one
of the four locations, for example, 20 patients were treated and those
receiving one 150 IU lozenge per day reported results consistent with one-a-
day groups throughout the study. However, placebo patients at this same site
noted only minimal improvement relative to those at the other sites.
Fox also said that the search for relief for fibromyalgia sufferers,
estimated to number between 4 million and 7 million in the U.S. alone, is
important because current therapeutic options are inadequate and no medication
has been specifically approved by the FDA for treatment. Rheumatologists
typically prescribe pain relievers, sleeping aids, anti-depressants and
exercise for patients with the syndrome.
"Fibromyalgia syndrome has a significant impact on the quality of life and
the productivity of patients, and thus represents a large market with unmet
needs," said Dr. Joseph Cummins, President and CEO of Amarillo Biosciences.
"However, this is the second study in which we have seen benefit from a 50-IU
IFN alpha lozenge given once daily in relief of morning stiffness."
Like Dr. Fox, Dr. Cummins noted that the robust placebo response in the
most recent clinical trial was a concern, but said future studies will be
designed to allow for this effect and the effects of concomitant medications
(such as amitriptyline). Amarillo Biosciences' COO Kathleen Kelleher agreed,
saying, "Prior to commencing further clinical trials, we will consult with a
group of expert clinicians and opinion leaders in fibromyalgia syndrome
research to review the results of our studies to date and to assist us in
designing our future trials."
Amarillo Biosciences, founded in 1984, is a pioneer in the development 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 opportunistic infections in patients who are HIV
positive. ABI is conducting a Phase III clinical program in Sjogren's
syndrome in the United States and has already enrolled over 450 of the
targeted 500 subjects in pivotal trials. The company is targeting an initial
filing for regulatory approval in Sjogren's syndrome by the end of this year.
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.amacell.com
CONTACT:
Kathleen Kelleher, Chief Operating Officer,
806-376-1741, #15, or email, kkelleher@amarbio.com, or Philip C.
Fox, D.D.S, Director of Research & Development, 301-320-8200, or
email, pcfox@amarbio.com, both of Amarillo Biosciences, Inc.
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