Ekomed Unveils Major Advance in Treatment of Multi-Drug Resistant Tuberculosis (MDR-TB)

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Ekomed LLC, a developer and manufacturer of herbal immunomodulators announces encouraging results of a clinical trial of its lead product, Dzherelo (Immunoxel), in patients with MDR-TB.

Ekomed LLC publishes study of immunoadjuvant therapy with Dzherelo (Immunoxel) in patients with drug-resistant TB.

The findings are published in 2009 issue of Research Journal of Medical Sciences (Volume 3; Pages 36-41). In this new study safety and efficacy of phytoconcentrate Dzherelo as an adjunct immunotherapy for treatment of TB was compared to standard anti-mycobacterial drugs by examining 66 patients with active pulmonary tuberculosis. Among them 48 individuals had multi-drug resistant (MDR) form of TB who were divided into two matching groups to receive either individualized anti-TB therapy (ATT) or ATT with 50 drops of Dzherelo twice-per-day. Patients were followed for 3 months and then examined for sputum smear clearance and chest X-ray.

As a result 63.6% (21/33) and 81.8% (27/33) patients on Dzherelo had negative sputum smear after 2 and 3 months of therapy respectively. In contrast only 7 out 33 patients (21.2%) on ATT became negative for TB bacteria after 3 months (P=0.0002).

Administration of Dzherelo resulted in complete healing of pulmonary infiltrations and cavities in 12 (36.4%) patients in Dzherelo group, while only one patient (3%) treated with TB drugs had responded (P=0.0008).

The safety of Immunoxel was assessed by liver damage markers such as bilirubin, ALT, cholinesterase, gamma-glutamyl transpeptidase, and thymol turbidity test. Based on these liver function tests Dzherelo was found to be very safe - it actually improved or reversed liver damage caused by ATT.

Such results indicate that when Dzherelo is added to ATT it can produce dramatic clinical, microbiological and radiological improvements in difficult-to-treat TB patients. These new findings support clinical investigations by other investigators showing that immune intervention with Dzherelo accelerates and enhances the outcome of tuberculosis therapy. In earlier published clinical trials, the oral immunomodulator Dzherelo (Immunoxel) has been shown to be safe and effective as an adjunct immunotherapy in TB patients including patients with MDR-TB and extensively drug resistant TB (XDR-TB). Similar benefits were observed in patients with TB who were also infected with HIV.

" MDR-TB is extremely difficult to treat, said Mr. Volodymyr Pylypchuk - the Scientific Director of Ekomed. The average success rate of treating MDR-TB by best available drugs today is only about 57%. However, such results are reached after highly intensive therapy which lasts on average 18 months. We have been able to achieve better success rate (63%) in as little as 2 months - which is a record time that has never been reported before, anywhere in the world.

To TB physicians the chest X-ray remains the most dependable tool to measure treatment outcome. Our X-ray data are equally impressive. We have observed more than 10-fold higher pulmonary lesion-clearing rate in patients who received Dzherelo supplement as compared to control patients.

Another aspect worthy of mentioning is that negative side-effects effects caused by TB drugs are common and can occur in up to 75 % of patients. When we measured liver damage markers, we found that Dzherelo acts as hepatoprotective agent and was even capable to reverse the damaging effect of TB drugs.

All these findings are consistent with findings from other Ukrainian TB doctors who investigated the property of Dzherelo in their clinics. We now look forward to see results from our international collaborators who have expressed interest to test our herbal preparation in their own countries".

About Ekomed
Ekomed LLC is Ukrainian research-driven phyto-pharmaceutical 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 undertakes ethically-responsible basic and clinical research efforts to increase adjunct treatment options to needy patients. Ekomed also strives to publish its research results in reputable medical journals. For more information, visit http://www.ekomed.com.ua

Ekomed is committed to development of innovative therapies that offer advantages in the treatment of infectious diseases - including TB, HIV, hepatitis, and influenza. Ekomed is committed to seeking expanded access to people living in the world's poorest countries and those hardest hit by the AIDS and TB, 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 those patients who have limited or no treatment options.

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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Volodymyr Pylypchuk
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Allen Bain
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