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`7 of 17 DOCUMENTS
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`Copyright 1998 Business Wire, Inc.
`Business Wire
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`September 17, 1998, Thursday
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`DISTRIBUTION: Business Editors
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`LENGTH: 687 words
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`HEADLINE: ICOS Announces Clinical Results and Initiation of Trials
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`DATELINE: BOTHELL, Wash.
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`BODY:
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`Sept. 17, 1998--ICOS Corporation (Nasdaq:ICOS) announced today that Thomas P. St. John, Ph.D., Vice President
`of Therapeutic Development will report results from several clinical trials at the Newsmakers in the Biotech Industry
`Conference in New York. As a part of ICOS' ongoing development plan, product candidates have been evaluated in
`multiple disease indications.
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`LeukArrest(TM)
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` A 48 patient Phase 2 clinical trial with LeukArrest(TM) (previously referred to as Hu23F2G) to evaluate safety
`and efficacy following an ischemic stroke has been completed. The results indicated that LeukArrest(TM) was safe in
`this patient population and, while not powered to show statistical significance, the results suggest that the high dose
`group had improved neurological outcomes and had a higher positive response rate compared to placebo. Plans are un-
`derway to design a pivotal Phase 2/3 clinical trial.
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` The analysis of the Phase 2 single dose clinical trial with LeukArrest(TM) in 169 patients experiencing acute ex-
`acerbations of multiple sclerosis (MS) has been completed through the first ninety days of follow-up. The study, de-
`signed to evaluate the recovery of neurologic function following exacerbation of a patient's disease, demonstrated no
`clinical benefit for LeukArrest(TM. A second study, a Phase 2 multiple dose trial in approximately 50 MS patients suf-
`fering acute exacerbations, is continuing enrollment.
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`Pafase(TM)
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` A Phase 2 trial with Pafase(TM) (the Company's recombinant human enzyme, formerly called rPAF-AH) in 18
`patients at risk to develop acute respiratory distress syndrome demonstrated that Pafase(TM) is well tolerated and
`non-antigenic. While this study was designed to determine safety and pharmacology, it additionally suggested an im-
`provement in blood oxygenation and severity of multiple organ dysfunction compared to patients treated with placebo.
`The improvements observed were not statistically significant. Based upon these results a double blind placebo con-
`trolled Phase 2 efficacy trial has been initiated and is expected to enroll approximately 240 patients.
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` The analysis of the Phase 2 clinical trial with a single dose of Pafase(TM)in an inhaled allergen-challenge model
`with 15 subjects has been completed. The primary endpoints in this trial were safety and efficacy as measured by lung
`function. In this placebo controlled, crossover study, there was no improvement in the early or late asthmatic responses
`following Pafase(TM) treatment. Additional trials utilizing a different dosing regimen are under consideration.
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`ICM3
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`ARGENTUM EX1035
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`Page 2
`ICOS Announces Clinical Results and Initiation of Trials Business Wire September 17, 1998, Thursday
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` The Phase 1 clinical trial with ICM3 was designed to evaluate safety and pharmacology in 25 patients with mod-
`erate to severe psoriasis. The single dose study has been completed and a multi-dose trial is planned. The Phase 1/2
`multi-dose trial in Europe continues to enroll patients.
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` IC351
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` In a 44 patient overseas study assessing the safety and efficacy (erectile response) of IC351 (the Company's
`phosphodiesterase 5 inhibitor for the treatment of erectile dysfunction), IC351-treated patients showed significant im-
`provement relative to placebo-treated patients in the primary endpoint (p<0.001) and all secondary endpoints. A second
`study evaluating safety and pharmacokinetics in healthy subjects was completed and shows that IC351 was
`well-tolerated. Additionally, patient enrollment in a study testing safety and efficacy has been initiated in the United
`States.
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` ICOS is discovering and developing new pharmaceuticals by seeking points of intervention in the inflammatory
`process that may lead to specific and efficacious drugs. ICOS' research and drug development programs involve several
`acute and chronic conditions.
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`
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`CONTACT: ICOS Corporation
` Lacy Fitzpatrick, 425/485-1900
` http://www.businesswire.com/cnn/icos.htm
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`LOAD-DATE: September 18, 1998
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