Synergen Inc. announced Thursday that it has begun Phase IIclinical trials of Antril, its Interleukin-1 receptor antagonist forsepsis and septic shock.
Each year 500,000 people in the United States develop sepsis, acomplication of bacterial infections. About half of the 200,000cases that develop septic shock are fatal.
The Boulder, Colo., company expects to test 100 patients at 14U.S. medical centers during the next six months. KennethCollins, vice president of finance, said several doses of Antrilwill be tested in patients with sepsis or septic shock. Patientswill receive the drug intravenously.
Interleukin-1 receptor antagonist (IL-1ra) prevents IL-1 fromcausing the cascade of cardiovascular and organ failuresleading to septic shock. The protein was proven safe in Phase Istudies. In addition, "IL-1ra gave very exciting results in arabbit septic shock model," said Collins.
Synergen expects that IL-1ra will be effective against septicshock caused by all types of bacteria. Two treatments presentlyexpected to complete Food and Drug Administration review,Xoma Corp.'s E5 and Centocor Inc.'s Centoxin, are monoclonalantibody-based therapies that inactivate only those endotoxinsproduced by gram-negative bacteria. Other septic shocktreatments under development include Chiron Corp.'s anti-tumor necrosis factor monoclonal antibody and ImmunexCorp.'s soluble IL-1 receptor fragments.
Synergen's stock (NASDAQ:SYGN) closed Thursday at $29.50 pershare, up $2.25. "The start of Phase II clinical trials is goodnews for Synergen," said Cowen & Co. analyst David Stone. Headded that Antril is not currently perceived as a threat to E5 orCentoxin, both of which are closer to market.
Synergen is also carrying out Phase I/II clinical trials of IL-1raas a subcutaneous treatment for rheumatoid arthritis.
-- Carol Talkington Verser, Ph.D. Special to BioWorld
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