AutoImmune Announces Results From Phase III Clinical Trial Of
Myloral(R) For Multiple Sclerosis
LEXINGTON, Mass,. April 21 /PRNewswire/ -- AutoImmune Inc. (Nasdaq:AIMM) today announced that preliminary
analysis of its Phase III trial for Myloral(R) showed no difference in response between active treatment and placebo. The
Company will conduct additional analysis of the Myloral(R) data before deciding what, if any, further efforts will be
taken with this product. AutoImmune currently intends to direct its resources toward the development of Colloral(R), its
product for rheumatoid arthritis, which is nearing completion of three Phase II clinical trials. Preliminary results of these
trials, which involve more than 800 patients, are expected to be announced next month.
The Myloral(R) Phase III trial was a two year study designed to demonstrate a significant reduction in neurologic attack
rates in patients suffering from multiple sclerosis. Patients were randomized into subgroups by DR type and sex.
Substantial reductions from baseline were observed in all active and placebo groups, but they were of comparable
magnitude. Disability associated with multiple sclerosis was examined as a secondary endpoint and there was no
difference between active and placebo in the rate of disease progression by this measure. The groups were also
indistinguishable in terms of safety parameters, with no serious adverse events attributable to treatment. All data from the
trial will be reviewed with the Food and Drug Administration.
"With the exception of safety, we are clearly disappointed with these results and Myloral(R) development will be put on
hold over the near term," noted Robert C. Bishop, Ph.D., President and Chief Executive Officer of AutoImmune. "We
are looking forward to the analysis of the data from our Phase II clinical trials for Colloral(R). With successful results in
these studies, we plan to initiate a Phase III trial program on this product before the end of the third quarter."
In other product development efforts, AutoImmune's partner in the diabetes field, Eli Lilly and Company, currently has
underway three Phase II trials of AutoImmune's product, AI-401. Eli Lilly is also providing AI-401 for the Diabetes
Prevention Trial (DPT-1) being conducted by the National Institutes of Health. Additionally, AutoImmune is conducting
a clinical trial of tolerizing peptides for the prevention of organ transplant rejection.
AutoImmune Inc. is a biopharmaceutical company developing a new class of drug therapies for the treatment of
autoimmune diseases. With highly focused use of its human and capital resources, the Company has brought five
product candidates, all based on the principle of oral tolerance, into human clinical testing.
This release contains forward-looking statements which involve risks and uncertainties. What may occur in the future
may differ significantly from what is discussed in the forward-looking statements due to a number of important factors,
including, but not limited to, the developmental stage of the Company's products and uncertainties of clinical trial results
and regulatory approval; the Company's capital requirements, history of operating losses and lack of product revenue
and its limited manufacturing and marketing experience; and the risks of technological change and competition.
These factors are more fully discussed in the Company's most recent Annual Report on Form 10-K filed with the
Securities and Exchange Commission. |
