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发帖数: 5997 | 1 Generex Provides Positive Update On Generex Oral-Lyn(TM) Pivotal Phase III
Trial
Press Release Source: Generex Biotechnology Corp. On Wednesday July 28, 2010
, 9:30 am EDT
WORCESTER, Mass., July 28, 2010 (GLOBE NEWSWIRE) -- Generex Biotechnology
Corporation (Nasdaq:GNBT - News), (www.generex.com), the leader in drug
delivery for metabolic diseases through the inner lining of the mouth, today
announced that it has now achieved 75% of the required number of per-
protocol completers in its ongoing six month pivotal global Phase III study
of Generex Oral-lyn(TM), the Company's proprietary buccal insulin spray
product. These early results suggest that, should the current trend be
maintained through the early 2011 completion date of the treatment phase of
all enrolled subjects, the use of Generex Oral-lyn(TM) will support a non-
inferiority claim relative to the standard-of-care injectable insulin. This
position will be reviewed following a formal interim analysis after the 90-
day results for all subjects become available.
It is gratifying for the Company to see a continuum of positive trends.
Initial trending outcomes revealed that insulin resistance was not observed
for subjects using Generex Oral-lyn(TM) and that subjects using Generex Oral
-lyn(TM) demonstrated, on average, no weight gain and an actual decrease in
Body Mass Index (BMI). This compared favorably to subjects using injectable
insulin that have, on average, gained weight and experienced an increase in
BMI. In addition, it was previously reported that when comparing
hypoglycemic events, subjects using Generex Oral-lyn(TM) were observed to
have a better Adverse Event profile than subjects using injectable insulin.
These previous findings along with current trends of non-inferiority using
recently collected information and extrapolations clearly positions this
study favorably.
"This latest study trend is exciting news for us," said Anna Gluskin, the
Generex President & Chief Executive Officer. "The Phase III study is on
track and we will look forward to further analyses as we near completion of
the study."
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