Immune Response Corp. announced Tuesday that it has begunPhase I/II clinical trials with a vaccine therapy to treatrheumatoid arthritis. The treatment is designed to targetspecific T cells responsible for the disease.

Immune Response spokesman Steven Basta said he believesthe company is the first to enter human trials with atherapeutic vaccine for rheumatoid arthritis. The treatment,based on Immune Response's core technology, involves thestimulation of a response against T cells, which the companybelieves are critical in the attack on the joint tissue inrheumatoid arthritis patients.

Animal studies showed that isolation of specific T cellsresponsible for autoimmune disease, followed by vaccinationwith a portion of that specific T cell receptor, protected animalmodels against the diseases.

"We have designed this product to target these specific T cells,and by developing a therapeutic vaccine from the receptor ofthese potentially harmful T cells, we hope to stimulate theimmune system to control these cells," Basta said.

The advantage of a vaccine for rheumatoid arthritis overtraditional treatments, such as general anti-inflammatories,analgesics or other immune suppressors, is that a vaccinetherapy uses the body's natural systems to fight the disease-causing agent.

According to Basta, none of the current therapies address thespecific T cells that are attacking the joint and causing thedestruction of the joint. "If the treatment is effective, we maybe able to shut down the disease process at its initiationwithout compromising or damaging the immune system," hesaid.

Edward Kim, an analyst with Robertson, Stephens, & Co. in SanFrancisco, told BioWorld that although companies such asSynergen Inc., Xoma Corp., Centocor Inc. and Seragen Inc. alsohave products in human trials for treatment of rheumatoidarthritis, none of them are using a therapeutic vaccineapproach.

"Immune Response's preclinical models look good, and there'sno other company using this T cell receptor approach forrheumatoid arthritis," said Kim.

But Joyce Lonergan, an analyst with Cowen & Co. in Boston,cautioned that Immune Response's trials are at a very earlystage. Although the studies are a step forward for the company,she said, much work must be done before a potential therapyfor rheumatoid arthritis is uncovered.

"There are so many approaches under development forrheumatoid arthritis," Lonergan said. "But Immune Response'sresearch will at least help the field further understandautoimmune system mechanisms."

The rheumatoid arthritis vaccine is the company's secondproduct in clinicals and the first of a family of products beingdeveloped using Immune Response's T cell receptor approachfor the treatment of autoimmune diseases, including multiplesclerosis and type I diabetes.

In a 50-50 partnership with Rhone-Poulenc Rorer, ImmuneResponse is developing an HIV therapeutic vaccine in anationwide Phase II/III clinical trial, which ends this year. Ifresults from these studies are positive, the company hopes tofile a product license application (PLA) next year.

According to Lonergan, Immune Response's market value isdriven by its AIDS vaccine progress, which has recently slowed,as has that of other companies developing AIDStherapies."Immune's stock was relatively volatile in July duringthe Amsterdam AIDS conference, and since then has remaineddown but on par with others working in the AIDS field,"Lonergan said.

The company's stock (NASDAQ:IMNR) lost 50 cents a share onTuesday to close at $17.50.

Basta told BioWorld that the San Diego company intends todevelop its rheumatoid arthritis vaccine independently and isnot looking for a licensing partner. "We have the resources todevelop the product internally and have chosen to keep all therights to the technology and develop it ourselves," Basta said.

Rheumatoid arthritis is a debilitating disease that affectsbetween 3 million and 4 million people in the U.S.

-- Michelle Slade Associate Editor

(c) 1997 American Health Consultants. All rights reserved.

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