AMARILLO, TX -- March 10, 2000 -- A just-completed Phase II clinical study conducted by Amarillo Biosciences, Inc., 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.
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.
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.
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