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PLYMOUTH MEETING, Pa., Oct. 25 /PRNewswire-FirstCall/ -- Genaera Corporation (Nasdaq: GENR) is providing the following summary of highlights related to the successful first Phase 1 study of trodusquemine and additional preclinical data expanding the support for selectivity and specificity of the drug in preclinical models from the North American Association for the Study of Obesity (NAASO) Annual Meeting in New Orleans:
-- Interim results from Study MSI-1436C-101 presented at Genaera's poster
session, "First in Human Use of MSI-1436 (Trodusquemine), a Centrally
and Peripherally Acting Selective PTP1B Inhibitor," demonstrated that
the drug was safe and well tolerated by the healthy, overweight and
obese volunteers at doses well above the anticipated therapeutic dose
level with no evidence of serious adverse events. No pharmacodynamic
effects were anticipated or observed in this study with a single dose
of MSI-1436.
-- There were no significant changes in vital signs, cardiovascular
parameters (as assessed by ECG and cardiac telemetry), clinical
laboratory or hematology parameters. Moreover, pharmacokinetic (PK)
profiles of trodusquemine in the first five cohorts of the study showed
a consistent pattern with minimal subject-to-subject variability and
linearity was observed across the range of doses studied. Values for a
wide range of endocrine and metabolic biomarkers as well as evaluations
of mood and cognition were also found to be stable across the subjects
receiving all levels of the drug or placebo during the trial.
-- Consequently, these positive Study MSI-1436C
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