Herbal Immunotherapy Alters Cytokines in Patients with TB and HIV

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Ekomed LLC, a developer and manufacturer of over 26 botanical phytopreparations announces that the Company has published positive results of a clinical study of herbal immunomodulators Dzherelo (Immunoxel) and Anemin in AIDS patients with TB in a leading journal in cytokine research field.

Ekomed LLC publishes effect of Dzherelo (Immunoxel) and Anemin on cytokine production in 60 patients with TB and HIV co-infection.

Paper entitled "Changes in cytokine profiles in tuberculosis patients with HIV in response to immunomodulating therapy with herbal supplements" from the Ekomed company is published in the December issue (Volume 44; Pages 392-396) of Cytokine - the official journal of the International Cytokine Society.

In earlier published clinical trials, the oral immunomodulator Dzherelo (Immunoxel) has been shown to be safe and effective as an adjunct immunotherapy in tuberculosis patients including patients with multi-drug (MDR-TB) and extensively drug resistant TB (XDR-TB). Similar benefits were observed previously in patients with TB who were also infected with HIV. The WHO estimates that globally, about one-third of the world's population is infected with the Mycobacterium tuberculosis bacteria that cause TB, and each year approximately 9 million people become ill with the disease, and 2 million of those die. TB patients with HIV are 30 times more likely to die and treatment options for them are limited.

In the latest series of studies of Dzherelo (Immunoxel) and Anemin - two supplements from Ekomed - when combined with conventional anti-tuberculosis therapy (ATT) were shown to modulate the output in cytokines that appeared to be radically different than in patients on chemotherapy alone. Sixty HIV-positive patients with active pulmonary TB were equally divided into three matched groups to receive either ATT, ATT+Dzherelo, or ATT+Dzherelo+Anemin. Peripheral blood samples were measured by ELISA for plasma levels of IL-2, IL-6, TNF-alpha, IFN-gamma, and IFN-alpha. After 6 months of follow-up Dzherelo and Dzherelo+Anemin combinations produced 61% (P=0.005) and 44.4% (P=0.06) higher levels of IL-2, whereas in ATT group they were reduced by 33.1% (P=0.002). The levels of IL-6 increased by 17% (P=0.15) in ATT group, but declined in both immune intervention groups by 26.2% (P=0.007) and 21.3% (P=0.22). TNF-alpha was suppressed in the two immunotherapy groups by 19.1% (P=0.06) and 76.3% (P=0.02), respectively, but had risen by 14% (P=0.42) in ATT patients. The pattern of production of IFN-gamma was opposite to that of TNF-alpha, but statistical significance was stronger in patients receiving ATT and Dzherelo+Anemin than in Dzherelo group: -34% (P=0.004), +31.9% (P=0.008), and +17.3% (P=0.33), respectively. Moderately decreased levels of IFN-alpha were observed in all treatment arms (range 0.9-16.6%) but differences were not significant. Despite considerable intra-group variation in cytokine production, the baseline inter-group averages were not statistically different indicating that the results were not biased by sample heterogeneity.

Immunomodulators used in this study appear to act by enhancing natural immune response against TB. Expanded study of other cytokines and correlates relevant to control and protection from TB and HIV is needed in order to identify biomarkers of favorable treatment outcome, which may aid design of better immune interventions and vaccines.

"Present findings are consistent with the unique property of Immunoxel demonstrated in earlier clinical study in 40 TB/AIDS patients, which was published this year in the International Journal of Immunopharmacology," said Mr. Volodymyr Pylypchuk, scientific director of the Ekomed LLC. "We now have evidence that HIV viral load reduction and increase in CD4 counts correlate with very intriguing and favorable changes in cytokines' production. These changes are very consistent and will allow us to establish the correlates of immune response associated with favorable clinical outcome in patients with dual HIV and TB infection".

Ekomed is committed to development of innovative therapies that offer advantages in the treatment of infectious diseases - including TB, HIV, hepatitis, and influenza. Ekomed's efforts to develop adjunctive therapies have been under way since late 1980's. Ekomed began its HIV research back in 1998 and TB research even earlier. Ekomed is one of very few botanical companies that are committed to scientifically sound clinical and basic research according to strict international standards. Ekomed is committed to ensuring affordable access to herbal medicines for infectious diseases and other illnesses. Ekomed is also committed to seeking expanded access to people living in the world's poorest countries and those hardest hit by the AIDS and TB epidemics, including through working with partners to achieve better outcome and cost savings.

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

About Ekomed
Ekomed LLC is the only Ukrainian research-driven phyto-pharmaceutical company dedicated to promote science and patients' well-being. Established 15 years ago, Ekomed discovers, develops, manufactures and markets botanical medicines to address unmet medical needs. The Company undertakes ethically-responsible basic and clinical research efforts to increase adjunct 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 @ bk.ru

Dr. Allen Bain
Zodiac Capital Limited
allen.bain @ zodiaccap.com


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