Global Health Ventures Announces Interim Data From The European Clinical Trails Of X-Excite Vs. Viagra

Main Category: Clinical Trials / Drug Trials
Also Included In: Erectile Dysfunction / Premature Ejaculation
Article Date: 31 Mar 2011 – 1:00 PDT

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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®. 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®, a good sign for drug’s acceptability as biosimilar. Additionally the T max was lo! wer (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®, 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® 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® 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®.

“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.

About Sublingual Technology

The Company’s sublingual formulation is designed to enhance drugs to be delivered to the body without the need for injection. This design enables the vast majority of pharmaceutical drugs to be rapidly absorbed through the mucosal membrane (tissues of the mouth) quickly and efficiently. This tec! hnology works well for drugs that need faster results and have major side effects associated with gastrointestinal and/or liver breakdown. It is scientifically accepted that sublingual drug delivery route is the fastest and most efficient way of drug delivery after direct injection. The technology is tested against 40 major drugs and all can benefit from it.

Source:

Global Health Venture



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