(PRWEB) January 26, 2005
Vitogen, Inc. ("Vitogen" or the "Company") announced the clinical study results of its randomized, double-blind, placebo-controlled clinical trial of AxcilTM (GL49) for the treatment of mild and moderate erectile dysfunction (ED). The paper describing this study has been submitted for publication in European Urology, a peer-reviewed, prominent international journal.
About Erectile Dysfunction (ED)
ED is defined as the consistent inability to obtain and maintain an erection sufficient for completing sexual intercourse. The condition may be correlated with aging, cardiovascular conditions, hypertension, diabetes, hyperlipidemia, drinking and smoking. In addition, some prescription drugs and psychogenic issues may contribute to ED. ED is a widespread problem affecting estimated half of all men over age 40. About 150 million men worldwide and 30 million American men suffer from ED.
Current Erectile Dysfunction Treatments
Currently several PDE-5 inhibitors are used as effective first-line treatment for ED. They primarily target Nitric Oxide (NO) synthesis pathway in the vascular system. PDE-5 inhibitors contraindicated with nitrates and medications containing alpha-blockers. PDE-5 inhibitors have not been shown by any clinical study to have effect on sexual desire. Current literature indicates that about half of all patients who receive an initial prescription for a PDE-5 inhibitor do not renew the prescription due to adverse side effects, drug interaction issues, and/or lack of efficacy.
About AxcilTM (GL49)
AxcilTM (GL49) is a dietary supplement that contains a proprietary standardized botanical extract acting synergistically to promote erectile function and sexual desire in men. AxcilTM (GL49) is a combination of many ingredients and compounds, all of which are generally considered safe by United States Food and Drug Administration (FDA) and are on the list of FDA approved Old Dietary Ingredient List. Multiple pathways and mechanisms of action might be involved. Although the mechanisms are not completely understood, individual ingredients in AxcilTM (GL49) have been studied and reported by various laboratories. Several ingredients were shown to increase L-Arginine-NO pathway activity (important for penile smooth muscle relaxation and erectile function), some were found to increase testosterone production (one of the important mechanisms to increase sexual desire). Other potentially relevant mechanisms include increasing angiogenetic, cardiovascular protection and anti-oxidative activities. The ingredients in AxcilTM (GL49) may act synergistically in multiple pathways critical for sexual function and desire.
Clinical Study Design
The purpose of this study was to evaluate the efficacy and safety of AxcilTM (GL49) for the treatment of men with mild to moderate ED. 47 men with mild to moderate ED were randomized to received placebo or AxcilTM (GL49) for one month in a double-blind, placebo-controlled manner. Efficacy was assessed by International Index of Erectile Function (IIEF), Sexual Encounter Profile (SEP) questionnaires, global assessment questionnaires and diary after each sexual activity. Safety was assessed by subject report on adverse events and blood tests.
Clinical Study Results
After 4 weeks, subjects taking AxcilTM (GL49) continuously every 48 hours showed a significant improvement on erectile function, as measured by IIEF EF domain score (7.65 increase from baseline, P less then 0.0001), IIEF Question 3 and 4 (P less than 0.0001), IIEF overall satisfaction domain score (2.00 increase from baseline, P less than 0.003), rates of penetration success (91.60% from 55.80% at baseline, p less than 0.0001), intercourse completion (85.70% from 45.00% at baseline, P less than 0.0001) and rate of subjects retaining normal sexual function (62.5%, P less than 0.0001). In addition, AxcilTM (GL49) significantly increased IIEF sexual desire domain score (1.46 increase from baseline, P less than 0.01). Furthermore, GL49 significantly improved erection, sexual relationship and quality of life as measured by global assessment questionnaires. No significant improvement was noted in subjects taking placebo. GL49 was safe with no serious adverse events. The results suggest that AxcilTM (GL49) continuous therapy may significantly improve erectile function and sexual desire in men with mild to moderate erectile dysfunction.
Steven Wunschel, MD, a board-certified urologist and assistant clinical professor at UC Davis served as lead investigator in the study. Dr. Wunschel stated, ÂThe clinical study results are very encouraging. They suggest that AxcilTM (GL49) may be a safe, fast-acting, clinically proven natural product. It may not only improve sexual function, but also increases sexual desire.Â
Dr. Heather Liao, Chief Executive Officer of Vitogen stated, "This new clinical study data, and collectively all the pilot clinical study data before it, are very exciting and clearly demonstrate to me the potential of AxcilTM (GL49) as an effective and safe product for treating mild to moderate ED. In particular, we are very pleased to find that AxcilTM (GL49) can increase sexual desire in men with normal or low sex drive. And more importantly, AxcilTM (GL49) is safe with no serious side effects, only very low incidence of temporary and mild side effects. In addition, unlike current ED drugs, AxcilTM (GL49) appeared not to contraindicate with nitrate or alpha-blockers and is safe for men with cardiovascular conditions. Most importantly, the study subjects reported ability to perform at any time if taking AxcilTM (GL49) continuously every 48 hours. We are currently planning to conduct a bigger clinical trial at Stanford University VA Hospital to further test the efficacy and safety of AxcilTM (GL49) in mild to severe ED and as an on-demand treatment. We hope AxcilTM (GL49) will help many men suffering the problems and improve their erectile function and sexual desire."
Vitogen is a bio-pharmaceutical company founded by a biomedical PhD scientist. Vitogen is committed to improving peopleÂs health and wellness by developing science-based, clinically-proven, efficacious and safe phyto-pharmaceutical treatments for unmet medical needs. Through continuous innovations and rigorous clinical and scientific studies, Vitogen is developing next generation treatments for arthritis, hair loss, osteoporosis, sexual dysfunction, cancers, cardiovascular diseases, skin rejuvenation, AlzheimerÂs Disease, etc.
This press release contains forward-looking statements within the meaning of the "Safe Harbor" provisions of The Private Securities Litigation Reform Act of 1995, including statements regarding the interpretation of clinical results. Forward-looking statements provide Vitogen's current expectations or forecasts of future events. Vitogen's performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the supplement and pharmaceutical industries. Given these risks and uncertainties, any or all of these forward- looking statements may prove to be incorrect. You should not rely on any such factors or forward-looking statements. Vitogen undertakes no obligation to update publicly any forward-looking statement.
Contact: Dr. Heather Liao
Vitogen, Inc. 1-650-776-8378
Web site: http://www.axcil.com
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