Connective Therapeutics announces immune response data from multiple sclerosis t-cell receptor vaccines.

PALO ALTO, Calif.--(BUSINESS WIRE)--June 4, 1996--Connective Therapeutics, Inc. today announced results from a Phase I/II clinical trial sponsored by the company's collaborators. The data indicated more frequent and stronger regulatory T-cell responses in multiple sclerosis (MS) patients who received TCR peptide vaccines compared to placebo. In addition, patients who responded immunologically to the vaccines experienced clinical benefit as assessed by neurologists.

The data were presented earlier today at the American Association of Immunologists annual meeting being held in New Orleans by lead investigator, Arthur A. Vandenbark, Ph.D. of Neuroimmunology Research, Veterans Affairs Medical Center, Portland and Oregon Health Sciences Center. In his presentation, Dr. Vandenbark described the double-blind, placebo controlled trial involving 23 patients with chronic, progressive MS who were treated for 12 months with a native or substituted version of a VB 5.2 peptide vaccine or placebo. Each patient received weekly intradermal injections of 100 micron g peptide or 0.1 ml diluent for four weeks, and then monthly injections for an additional 10 months.

The results indicated that significant boosting of regulatory T-cells occurred in five of nine patients vaccinated with the substituted version, one of eight patients injected with native TCR peptide, and none of the patients receiving placebo. The proportion of responders in the most active group (the substituted TCR peptide vaccine) was 56 percent. These results are consistent with a previous open label trial where 64 percent of patients receiving this vaccine developed T-cell responses. In addition, four of the six patients who responded in the most recent trial also had a concordant decrease in the response to myelin basic protein (MBP), a neuroprotein potentially implicated in the pathogenesis of MS.

At the close of the study, a clinical composite score was used to determine whether patients were improved, stable, or worse compared to entry status. All TCR peptide vaccine responders (6/6) were clinically improved or stable, while only 7 of 17 TCR peptide non-responders were improved or stable. The vaccines were well-tolerated, with no evidence of adverse events attributable to TCR peptide treatment.

"These findings suggest that immunization with T-cell receptor vaccines has the potential to enhance the natural protective immunity that is dysfunctional in MS patients," said Dr. Vandenbark. "Boosting the body's natural immunity may provide long-term clinical benefit by arresting disease progression."

"We're encouraged by these early data generated by our collaborators and plan to confirm the results in a company-sponsored trial that we intend to initiate later this year," said W. Scott Harkonen, M.D., senior vice president of Product Development and Operations at Connective.

Connective Therapeutics is developing TCR peptide vaccines to arrest autoimmune disease processes by boosting the naturally occurring control arm of the immune system that functions inefficiently in immune-mediated diseases. TCR peptide vaccines are expected to elicit a "regulatory immune response" that can immunize against the activity of disease-causing immune cells, possibly arresting the autoimmune disease process at its earliest stage.

Connective Therapeutics, Inc., headquartered in Palo Alto, California, is focused on the development of novel therapeutics for serious connective tissue disorders. The company has three products in development for six initial indications: gamma interferon for atopic dermatitis and keloids; relaxin for scleroderma and other fibrotic indications; and TCR peptide vaccines for rheumatoid arthritis and multiple sclerosis. -0-

Special Note: This news release contains forward-looking statements that involve risks and uncertainties that could cause actual results or events to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, without limitation, those mentioned in Connective's prospectus dated January 31, 1996 under the heading "Risk Factors" and in Connective's Report on Form 10-Q for the quarter ended March 31, 1996 under the heading "Additional Factors That May Affect Future Results."

CONTACT: Sylvia Wheeler

Director of Corporate Relations

415/843-2857