INTERIM DATA SHOWS GOOD RESULTS FOR X-EXCITE VS. VIAGRA.
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.
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 technology 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.
About Global Health Ventures (OTCBB:GHLV)
Global Health Ventures is a specialty pharmaceutical company with expertise in drug delivery and formulation. The company has a proprietary platform technology for drug delivery via the sublingual (under the tongue) route. This unique method delivers drugs to the bloodstream quickly with minimal drug breakdown in the liver or gastrointestinal system, a process that can greatly reduce side effects associated with the drugs. The company's lead therapeutic product is a male sexual enhancement drug that is delivered via sublingual route and is called X-Excite. In experimental studies, X-Excite has been shown to reach the blood stream rapidly, producing maximal effect and having less of the unwanted side effects associated with oral delivery route. X-Excite is presently in clinical development in Europe. The company's second drug "Relax-B" is also under development in Canada for anxiety. And, the third drug will be an anti-migraine drug. The company plans to use the same technology to deliver a vast number of other FDA approved and non-approved drugs that require faster delivery, or reduced hepatic and gastrointestinal side effects. These include stress, sleeping disorders, pain killers, anti-allergy medications, heart and lung medication, migraine and addiction replacement therapies.
For more information, call 480/649-8224.
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|Date:||Apr 27, 2011|
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