Immunoxel Favorably Affects the Outcome of Antiviral Therapy in AIDS Patients

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Ukrainian scientists have developed a novel immunotherapeutic approach which helps to build a healthy immune system in AIDS patients and, which, at the same time, significantly enhances the inhibitory effect of conventional antiviral therapy on HIV replication.

Ekomed LLC has published highly promising findings from a clinical trial of Immunoxel in AIDS patients. The study results appeared in the May 2009 issue of peer-reviewed The Open Virology Journal published by Bentham Science Publishers (Nikolaeva et al., Effect of immunomodulating adjuvant Dzherelo (Immunoxel) in HIV infected patients receiving standard antiretroviral therapy. Open Virol J 2009:3;31-36; full copy of the paper is freely available online at http://www.bentham-open.org).

Since the introduction of modern antiretroviral therapy (ART), there has been a dramatic decrease in HIV-related morbidity and mortality. Suppressing HIV replication by ART can result in elevation of the CD4+ T-cell counts and consequently restoration of normal immunity. However, the degree of immune restoration that can be achieved with ART is often incomplete and can be poorest in those patients who have low CD4+ counts. Currently available immunotherapeutic options for AIDS patients are practically non-existent and largely unsuccessful. Novel approaches are urgently needed to enhance the immune function.

To address this unmet need the Ukrainian doctors have developed a highly successful method of enhancing the outcome of antiviral therapy, which at the same time helps to restore normal immunity.

Immunoxel has been evaluated in an expanded, matched-case, comparative clinical trial involving HIV infected patients in advanced disease stage. The control group of twenty AIDS patients received standard anti-retroviral therapy (ART) consisting of Zidovudine (AZT), Lamivudine (3TC), and Efavirenz (EFV). The immune intervention group of twenty HIV patients received 50 drops of Immunoxel twice per day in addition to ART.

At the end of study the total CD3 T-lymphocytes increased slightly in ART recipients (P=0.06), whereas among those who received Immunoxel they rose significantly (P=0.03). The population of CD4 T-cells has expanded by a half in ART recipients (P=0.002), whereas in Immunoxel treated patients they almost doubled (from 184 to 356; P=0.004). The accrual in absolute and relative number of CD8+ lymphocytes in ART and Dzherelo recipients was not significant. The CD4/CD8 ratio in Dzherelo recipients increased from 1.495 to 1.940 (P=0.03), but in the control group on antiviral drugs alone, the increase was not significant (P=0.14).

Immunoxel also produced changes in distinct immune cell populations that were not seen previously in any reported immunotherapy trials. For example, no changes in CD20+ B-lymphocytes were seen among ART recipients, but in Immunoxel patients this cell population returned to normal levels from 509 to 333 (P=0.00008). Similarly, the effect of ART on activated CD3+ HLA-DR+ T-cells was negligible (from 209 to 264 cells; P=0.02), but among those who received Immunoxel this cell population increased by 216% (from 161 to 348; P=0.0007). ART did not affect the proportion of CD3-CD16+CD56+ natural killer (NK) cells, but administration of Immunoxel raised NK cells by 52.7% (P=0.0001).

In addition to this impressive effect on various immune cell populations, Immunoxel has demonstrated a significant impact on viral load reduction. While about three-quarters of patients on ART displayed a decrease in viral load (P=0.008), almost every patient (95%) on Immunoxel had a decrease in their viral burden (P=0.001). Thus, Immunoxel has shown a favorable effect on the immune status and viral load when given as an immunomodulating adjunct to ART.

"In earlier published clinical trials oral immunomodulator Immunoxel (Dzherelo) has been shown to be very safe and effective as an adjunct immunotherapy in tuberculosis patients, including MDR and XDR TB. Similar benefits were observed in patients with TB who were also infected with HIV" said Mr. Volodymyr Pylypchuk, scientific director of the Ekomed LLC. "We now have shown that our product is an excellent and safe immunotherapeutic adjuvant not only to TB therapy but also to AIDS drugs. The increase in CD4 counts was two-fold higher among those who have had the combination of Immunoxel and ART. Other important populations of immune cells were also favorably affected by Immunoxel. What is remarkable is that patients who were in the immune intervention arm showed the decrease in viral load at much higher proportion than among those who received ART alone. Immunoxel could become an indispensable tool in AIDS therapy, especially when all other options have been exhausted."

"Our findings indicate that the improved immune function is closely associated with the inhibitory adjunct effect of Immunoxel on viral load," said Professor Lyudmila Nikolaeva, M.D., head of the Regional AIDS Center, in Kharkov, Ukraine, who is the lead author on the study.

Last year Ekomed has established a partnership with Zodiac Capital Limited - an investment banking group publicly listed on the NSX in Australia. This agreement is aimed to assure worldwide global access to Immunoxel, especially for needy TB and AIDS patients who have limited or no treatment options.

About Ekomed
Ekomed LLC is a research-driven biopharmaceutical company dedicated to serve patients first. Established 15 years ago, Ekomed discovers, develops, manufactures and markets botanical medicines to address unmet medical needs. The company is the pioneer of Ukrainian phyto-pharmaceutical industry. Ekomed undertakes ethically-responsible basic and clinical research efforts to increase treatment options to the people who need them. Ekomed also strives to publish its research results in reputable medical journals. For more information, visit http://www.ekomed.com.ua.

Media Contacts:
Volodymyr Pylypchuk
CEO and Scientific Director
Ekomed LLC
pylypchuk (at) bk (dot) ru
http://www.ekomed.com.ua

Dr. Allen Bain
Director
Zodiac Capital Limited
allen.bain (at) zodiaccap (dot) com
http://www.zodiaccap.com

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