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are expected to enable further study of trodusquemine to establish the
primary pharmacodynamic impacts of the drug (improvement of abnormal
glucose tolerance and appetite suppression) and to fully validate its
proof-of-concept in multiple-dose clinical studies.
-- It was also noted that Genaera is closing enrollment in the 101 Study
with the 40 mg/m2 cohort due to the occurrence of nausea which although
transient, was felt to be drug related. The Company saw no medical
need, at this point in development, to take Study 101 to the point of
organ toxicity because single doses of 40 mg/m2 are well above the
anticipated clinical effect dose.
-- A second poster presentation of preclinical data, "Trodusquemine is a
Protein Tyrosine Phosphatase 1B Inhibitor that Causes Differential
Weight Loss," provides additional positive data and confirms the high
level of selectivity of MSI-1436 as a powerful inhibitor of PTP-1B when
compared to a wide range of enzymatic and non-enzymatic targets. These
results provide further support for its potential as a safe and
effective therapeutic for the treatment of type 2 diabetes and obesity.
-- Additionally, since MSI-1436 does not affect the targets (i.e. DPP-IV,
CB1, 5HT2C or NPYR) of other major drugs in this area, we anticipate
the potential for additive or synergistic effects of treating patients
with a combination of MSI-1436 and these other therapies.
"Our first clinical trial of MSI-1436 was a successful study as we
achieved all of the goals we set out to reach in the 101 trial and found
our drug to be safe and well tolerated," commented Jack Armstrong,
President and Chief Executive Officer of Genaera. "A careful analysis of
the data strongly reinforces our continued optimism and our intention to
move forward with MSI- 14
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