Breakthrough in Extensively Drug-Resistant Tuberculosis (XDR-TB) Therapy

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Promising findings from Ukrainian XDR-TB immunotherapy trial are published in peer-reviewed journal "Current Research in Tuberculosis" from ScienceAlert Press. This clinical study revealed the drastic difference between standard TB drugs alone versus TB drugs supplemented with immune adjuvant regimen consisting of Ekomed phytoconcentrates.

Ekomed LLC announces key study results showing complete cure of all XDR TB patients who received its phyto-immunotherapy products. As opposed to 18-24 months of treatment with standard TB drugs, the immune intervention has shown to be 100% effective and reduced treatment duration to under four months.

The published study summarizes twelve XDR-TB individuals, seven of which in addition to standard anti-TB therapy (ATT) received Immunoxel (Dzherelo), Svitanok and Lisorm - all being phyto-pharmaceutical products manufactured by Ukrainian company Ekomed. All seven patients who received adjunct immunotherapy improved clinically and radiologically and were discharged after 3.7±0.8 months, with average/median time to mycobacterial sputum clearance 28/25 days. None of five patients on TB drugs alone improved after 9 months and one had died. Patients in immune intervention group gained 9.6 kg (P=0.0001) while those on ATT alone lost 1.4 kg. The levels of total bilirubin in Immunoxel group had decreased from 15.6 to 10.7 μmol/L. Similarly, the values of alanine transaminase (ALT) declined from abnormally high 42.6 IU/L to normal levels 22.0 IU/L (P=0.23). Patients on TB drugs alone had unchanged levels of bilirubin, but their ALT declined from 29.6 to 12.0 IU/L (P=0.02). The levels of hemoglobin in Immunoxel group rose from 104.1 to 118 g/L (P=0.07), whereas leukocyte counts descended to normal levels from 8.9 to 7.3 × 10*9 cells/L (P=0.18). Conversely, in patients on ATT alone, leukocyte counts rose from 8.7 to 13.8 × 10*9 cells/L (P=0.21), whereas hemoglobin declined to below normal levels from 116.4 to 96.6 g/L (P=0.18). These results show that immune-modulating interventions can favorably influence the efficacy of TB drugs. The difference between two treatment outcomes was highly significant (Mantel Haenszel odds ratio=11; P=0.0009 at 95% CI). Thus, adjunct phytopharmaceuticals are safe, shorten dramatically treatment duration, and can overcome drug resistance even in patients with XDR-TB.

Conventional TB chemotherapy success rates are inconsistent in patients with XDR-TB also known as Extremely Drug-Resistant TB. XDR-TB is defined as TB that is resistant to any fluoroquinolone, and at least one of three injectable second-line drugs (capreomycin, kanamycin, and amikacin), in addition to the two most commonly used drugs in the current first-line regimen, isoniazid and rifampin. Current XDR-TB treatment is extremely lengthy and complicated, with some strains virtually untreatable. XDR-TB is seen throughout the world but is most frequently seen in the countries of the former Soviet Union, Africa and Asia.

The US Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) surveys indicated that in the worst-affected countries, 10 percent of MDR-TB cases were XDR-TB. The WHO estimates that there were almost half a million cases of MDR-TB worldwide. Research is being carried out urgently to better understand XDR-TB, and the WHO and others have mounted an intensified global response to this escalating incidence of resistance being evidenced worldwide.

The Ekomed Director, Mr. Volodymyr Pylypchuk commented: "As long as TB is treated with a long, complex, decades-old antibiotics' regimen, XDR-TB will continue to remain a life-threatening disease with unmet needs. Immunomodulators, such as our Immunoxel product, work through totally new biological mechanisms, and are perhaps most effective alternative solution against both drug-susceptible and drug-resistant TB strains like M/XDR-TB or TB with HIV. The immune intervention, we have developed, drastically shortens treatment duration and can save countless lives right now. Our study conducted in Ukraine shows that we can offer a practical, cost-effective solution to the global TB crisis. We are now planning independent studies in Asia and Africa with the specific aim to recruit larger patient population to support our present and earlier published findings."

About Ekomed
Ekomed is committed to the development of innovative botanicals, 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 phyto-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 in Africa, Asia and Australia. For more information, visit http://www.ekomed.com.ua

About Zodiac Capital
Last year Ekomed has established a global marketing partnership with Zodiac Capital Limited - a publicly traded investment group listed in Australia. This relationship may potentially assure worldwide global access to the range of Ekomed products and especially Immunoxel, for those who have limited or no treatment options.

Media contacts:
Volodymyr Pylypchuk
CEO and Scientific Director
Ekomed LLC
pylypchuk @ bk.ru
http://www.ekomed.com.ua

Dr. Allen Bain
Director
Zodiac Capital Limited
allen.bain @ zodiaccap.com
http://www.zodiaccap.com

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Volodymyr Pylypchuk
Ekomed LLC
380 6677886655
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Allen Bain
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