The Immune Response Corp. and a Thailand companyentered into an agreement that could lead to testing ofImmune Response's immunotherapeutic vaccine in10,000 HIV patients in Thailand.

The trial in Thailand would be designed as acomplementary endpoint study to the 3,000-patient trialImmune Response plans to run in the U.S. The deal withBangkok, Thailand-based Trinity Medical Group Ltd. isthe first collaboration Immune Response has crafted sinceRhone-Poulenc Rorer relinquished its joint-developmentrights last March to the product, which now is beingcalled the Salk Immunogen.

In connection with the deal, Trinity Medical gets rights tothe product in Thailand and other Asian countries (notJapan or China) and would make a $15 million equityinvestment in Immune Response, at $15 per share, inthree equal installments pending the attainment of certainmilestones. The news, released Monday, resulted in a 43cent rise in the company's stock (NASDAQ:IMNR). Thestock closed Tuesday at $7.56, down 19 cents.

Charles Cashion, vice president and chief financial officerat Immune Response, said the arrangement with TrinityMedical was driven not by the financing but by thestrategic development advantage of having parallelendpoint studies ongoing. The product's name changewas made in honor of the immunogen's creator, JonasSalk, who recently passed away.

Trinity Medical also will fund all development of theproduct in Thailand, while the product will be providedby Immune Response. Regulatory officials in Thailandalready have approved a one-year placebo-controlledstudy that will test safety and immune response. Inaddition, Trinity Medical plans to do a 2,000-patientclinical endpoint study, and a 7,700-patient open-labeltrial, Cashion said.

Meanwhile, Immune Response's plan for a 3,000-patientstudy in the U.S. is under review by the FDA. That trial isproposed as a three-arm study _ two doses and placebo_ involving patients with CD4 counts between 300 and549, with patients being monitored to the endpoint of anAIDS-defining clinical condition.

"While we were happy to have them purchase stock at$15 per share, the primary purpose of the transaction wasto conduct a parallel clinical-endpoint study to morerapidly assess the clinical utility of the Salk Immunogenin HIV-infected patients," Cashion said "The studies tobe conducted in Thailand are at essentially no cost to us.That was one of the keys to this."

Cashion, while not disclosing specifics of the potentialmilestone payments, said they are related to regulatorysteps and commercial introduction of the product inThailand. The first $5 million milestone, he said, isexpected in 1996.

Immune Response, which had $55 million on June 30,1995, has about two years of cash, enough to proceedwell into its Phase III study, Cashion said. That U.S.study is designed to run for three years from the time ofthe first patient's injection, not three years fromenrollment completion, he said.

While the company plans to move forward, it still intendsto form some sort of collaborations for development ofthe Salk Immunogen in the rest of the world.

Last March Rhone-Poulenc Rorer, of Collegeville, Pa.,opted out of a joint venture _ called ImmunizationProducts Ltd. _ the companies formed in 1988 todevelop the vaccine. An RPR official said his companyhoped the vaccine would undergo accelerateddevelopment and perhaps approval based on Phase IIdata. But that didn't happen.

The Salk Immunogen, formerly called the HIV-1Immunogen, consists of inactivated HIV stripped of itsouter envelope protein, gp120, which then is purified andemulsified with an adjuvant. n

-- Jim Shrine Staff Writer

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