AxcilTM Proven by Clinical Trial to Be Effective and Safe for Improving Erectile Function and Sexual Desire

Vitogen Inc. announced the results of its clinical trial on AxcilTM (GL49) for improving male erectile function and sexual desire. A paper describing the study has been submitted for publication in a peer-reviewed, prominent international urology journal.

About Erectile Dysfunction (ED)
ED is defined as the consistent inability to obtain and maintain an erection sufficient for completing sexual intercourse. 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. However, they contraindicates with medications containing nitrates and alpha-blockers. They have not been shown by clinical study to have effect on sexual desire.

About AxcilTM (GL49)
AxcilTM (GL49) is a dietary supplement that contains a proprietary standardized botanical extract. Individual ingredients in AxcilTM (GL49) have been studied and reported by various laboratories to increase L-Arginine-NO pathway activity (important for penile smooth muscle relaxation and erectile function), increase testosterone production (one of the important mechanisms to increase sexual desire), and increase angiogenetic, cardiovascular protection and anti-oxidative activities.

Clinical Study Design
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<0.0001), IIEF Question 3 and 4 (P<0.0001), IIEF overall satisfaction domain score (2.00 increase from baseline, P<0.003), rates of penetration success (91.60% from 55.80% at baseline, p<0.0001), intercourse completion (85.70% from 45.00% at baseline, P<0.0001) and rate of subjects retaining normal sexual function (62.5%, P<0.0001). In addition, AxcilTM (GL49) significantly increased IIEF sexual desire domain score (1.46 increase from baseline, P<0.01). Furthermore, GL49 significantly improved erection, sexual relationship and quality of life as measured by global assessment questionnaires. 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, “The 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 increase sexual desire.”

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 the potential of AxcilTM (GL49) as an effective and safe product for treating mild to moderate ED. It was also found to increase sexual desire in men with normal or low sex drive, was safe with no serious side effects, appeared to be safe for men taking nitrate or alpha-blockers, and most study subjects reported ability to perform up to 48 hours with one dose. We are currently starting 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."

About Vitogen
Vitogen is a bio-pharmaceutical company founded by a biomedical PhD scientist. It is committed to improving people’s 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, sexual dysfunction, osteoporosis, cancers, cardiovascular diseases, hair loss, skin rejuvenation, Alzheimer’s 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, Inc. Web site: http://www.Axcil.com

CONTACT: Dr. Heather Liao 1-888-996-5888, hliao@vitogenpharma.com