Treatment

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.

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