Lexington, Massachusetts, August 4, 1997 -- AutoImmune Inc. (Nasdaq: AIMM) today announced that it has completed an active control study of Colloral® for rheumatoid arthritis. "The data from this trial demonstrate what we believe is a clinically useful therapeutic response," said Robert C. Bishop, Ph.D., President and CEO of AutoImmune. Dr. Bishop added that utilizing all of the information that has been generated to date on the more than 1,200 patients involved in the clinical development program for Colloral, the Company is now preparing an integrated efficacy and safety analysis for discussion at an end of Phase II meeting with the FDA. This meeting will determine subsequent steps in the approval process.
In continuing evaluation of data from the recently completed Phase III trial of Myloral® for multiple sclerosis, the Company reported that encouraging preliminary results from magnetic resonance imaging have been found for one of the four subsets of patients studied. Further analysis of this information is ongoing.
The Company also noted that it has received a U.S. patent on oral tolerance therapy for Type I diabetes. This application of the Company's technology has been licensed to Eli Lilly and Company, which has multiple Phase II trials currently underway worldwide.
AutoImmune reported a net loss of $9.0 million, or $0.55 per share, for the quarter ended June 30, 1997, compared with a net loss of $5.4 million, or $0.33 per share, for the same quarter one year earlier. Research and development expenses increased to $8.8 million for the second quarter of 1997, from $5.7 million in the comparable 1996 period. Net loss for the six months ended June 30, 1997 was $16.6 million, or $1.01 per share, versus a net loss of $9.5 million, or $0.59 per share, for the same period in 1996. As of June 30, 1997, AutoImmune's balance sheet showed $36.6 million in cash and marketable securities.
AutoImmune Inc. is a biopharmaceutical company developing a new class of drug therapy for the treatment of cell-mediated inflammatory conditions. With highly focused human and capital resources, the Company has advanced several 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. The Company's actual results may differ significantly from results 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; 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.