Global Health Ventures Announces Interim Data From the European Clinical Trails
of X-Excite vs. Viagra
VANCOUVER, British Columbia, March 30, 2011 (GLOBE NEWSWIRE) -- Global Health
Ventures Inc. (OTCBB:GHLV), a specialty pharmaceutical company, is pleased to
announce the interim results of the clinical trials conducted in Europe under
the EMEA guideline protocols for its lead therapeutic drug, X-Excite.
Data analysis from a small number of patients showed the drug to meet the three
Pharmacokinetics (PK) end points. Blood analysis of the patients receiving
X-Excite showed the drug to appear in the blood 173% faster than Pfizer
Viagra(R). By 10 minutes about one quarter of peak concentration (T max Value)
apeared in the blood. Further, X-Excite (blood concentration, C max) never
exceeded the C max of Viagra(R), a good sign for drug's acceptability as
biosimilar. Additionally the T max was lower (about 15%), and better (wider)
spread, a possible sign of less side effects. Finally it appeared that X-Excite
remains in the blood slightly longer than Viagra(R), possibly due to some
gastric absorption, thus may provide a longer performance. Although these are
the results of a small number of patients, it indicates a highly positive trend
and it is meeting our expectations.
Additional studies are underway and further data will be released upon their
availability. In this study we compared the blood profile of X-Excite with
Pfizer's Viagra(R) in a neck to neck study. In the trials, an open label PK
profiling of both drugs were conducted in 24 patients of which 12 received
Viagra(R) and 12 received X-Excite. X-Excite is a sublingual formulation of
sildenafil citrate. Sildenafil citrate is used to make one of Pfizer
Incorporated's largest sellers Viagra(R).
"We are very pleased with the interim data thus far obtained and looking forward
to get additional data, and full blood profiling from our partners in Europe.
The data obtained from this small study is highly encouraging and merits the
next study to be conducted under FDA guidelines in the United States," said Dr.
Hassan Salari, Global Health President & CEO.
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