SEATTLE, Dec. 29, 2010 /PRNewswire-FirstCall/ — Omeros
Corporation (Nasdaq:
OMER), a biopharmaceutical company committed to discovering,
developing and commercializing products focused on inflammation and
disorders of the central nervous system, today announced results
from the Phase 1/2 clinical trial of OMS201, the Company’s
urological PharmacoSurgery™ product candidate. OMS201 is a
proprietary combination of an anti-inflammatory agent and a smooth
muscle relaxant, each with well-known safety and pharmacologic
profiles.
Based on the successfully completed Phase 1 trial of a lower
concentration of OMS201, this Phase 1/2 study was designed to
evaluate the safety and systemic absorption of two sequentially
higher concentrations of OMS201 added to standard irrigation
solution and delivered to patients undergoing ureteroscopy for
removal of ureteral or renal stones. This multicenter,
double-blind, placebo-controlled study also explored potential
efficacy endpoints but was not powered to assess efficacy. Based on
an interim analysis of the pharmacokinetic data, which demonstrated
low maximal systemic absorption of the active ingredients, trial
enrollment was truncated from the originally planned 36 patients to
a total of 24 patients.
OMS201 was safe and well tolerated in this study. The incidence
of adverse events was similar in the two OMS201-concentration arms
and the group receiving vehicle. No adverse events were considered
treatment-related by investigators. There were no deaths or
discontinuations for adverse events. Only one serious adverse event
was reported, which occurred in a vehicle-treated patient.
“We are pleased with the results of this trial, which
demonstrated an absence of side-effects even at a concentration of
OMS201 ten times higher than that examined in our earlier Phase 1
clinical study,” said Gregory A. Demopulos, M.D., chairman
and
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