Just mentions the gates foundation input into the study. It is...

Just mentions the gates foundation input into the study. It is also of interest that we now have a leading antiviral specialist from africa (nigeria) also very interested in Immunoxel.

Faster TB Healing by Combining Dzherelo (Immunoxel) with TB Drugs
The clinical study in 75 first-diagnosed TB patients published in the monthly journal of journal of the European Society of Clinical Microbiology and Infectious Diseases reveals that when standard, first-line TB drugs are combined with Dzherelo (Imunoxel), the combination can produce significant clinical and radiological improvements and clearance of M. tuberculosis at higher rate than in patients on TB drugs alone. Biochemistry and hematological analysis of blood samples support favorable adjunctive effect of Dzherelo, which has not shown any adverse effects throughout the study duration.

Kiev, Ukraine May 29, 2009 -- Ekomed LLC announces that its 75-patients' clinical trial has been published in the May issue of a prestigious, high-impact Clinical Microbiology and Infection journal of the European Society of Clinical Microbiology and Infectious Diseases. The journal publishes peer-reviewed papers that present basic and applied research relevant to therapy and diagnostics in the fields of microbiology, infectious diseases, virology, parasitology, immunology and epidemiology. The information about the journal can be found at http://www.wiley.com/bw/journal.asp?ref=1198-743X.

Tuberculosis (TB) is a re-emerging global public health problem, especially in Asia, Africa and Eastern Europe. The success rates of therapy in Eastern Europe, including Ukraine, are substantially below average when compared with other regions of the world. In addition the Ukraine has worsening epidemics of drug resistant TB that is increasingly converging with HIV. Despite availability of TB drugs the situation is far from ideal and better therapeutic interventions are clearly needed to reverse the current trend.

Oral immunomodulator Dzherelo is used in Ukraine for the management of both TB and HIV infections, including patients co-infected with TB and HIV. Dzherelo was approved in 1997 by the Ministry of Health of Ukraine as an immunomodulating supplement, which so far has been used by hundreds of thousands individuals for various indications including chronic bacterial and viral infections, autoimmune diseases, and malignancy. In 1999 Dzherelo was recommended by the health authorities of Ukraine as an immune adjunct for treatment of tuberculosis.

Earlier clinical studies have demonstrated that Dzherelo can increase CD4 T-lymphocytes, decrease viral load and helps to achieve better clinical response when combined with standard anti-retroviral (ART) or anti-tuberculosis therapy (ATT). Dzherelo has been found to reduce the incidence of opportunistic infections and reverse TB-associated wasting. Dzherelo has also been found to alleviate the hepatotoxicity associated with ATT as evidenced by improvement of liver function tests. However, these studies have not dealt with the effect of Dzherelo on other clinical parameters associated with TB. The published study was, thus, aimed at defining the adjunct effect of Dzherelo on clinical and radiological symptoms as well as select biochemical and blood parameters among patients with cavitary and infiltrating pulmonary TB. The advantage of adding Dzherelo to standard ATT was compared to a treatment regimen consisting of ATT alone.

Open-label, 60-days trial conducted at the Kharkov National Medical University was aimed to compare the adjunctive effect of oral immunomodulator Dzherelo to standard TB chemotherapy (ATT) consisting of izoniazid (H), rifampicin (R), pyrazinamide (Z), and streptomycin (S) administered under directly observed therapy (DOT). Group 1 with cavitary TB (n=28) and Group 2 with infiltrating pulmonary TB (n=17) received 50 drops of Dzherelo twice daily in addition to HRZS. Group 3 (n=30) which served as a control received ATT only. Liver damage indicators, bilirubin, ALT and AST decreased to normal levels in Groups 1 and 2 but increased significantly in Group 3. Kidney failure markers, urea and creatinine, normalized in Dzherelo recipients but unchanged or worsened in ATT group. The changes in serum catalase, lactate dehydrogenase, malondialdehyde, and diene conjugates suggest that Dzherelo downregulates TB-associated inflammation. The anti-inflammatory property of Dzherelo is further supported by favorable hematology picture, reduced erythrocyte sedimentation, and faster deffervescence. Radiological recovery was significant in both Dzherelo groups but not in the control (P=0.0085, P=0.025, and P=0.23). These findings correlated positively with sputum smear conversion and clinical findings (r=0.94; P=0.05). Mycobacterial clearance at day 30 was observed in 77%, 72%, and 40% of patients in Groups 1, 2, and 3. After 2 months sputum conversion rates were 93%, 89% and 70% respectively. The 60-days treatment outcome for Groups 1, 2, and 3 as assessed by improvement in clinical symptoms and respiratory function attained P values 0.008, 0.25, 0.72 and 0.013, 0.48, 0.0015 respectively. Dzherelo is thus useful as an immunotherapeutic adjunct to management of TB.

The Ekomed Director, Mr. Volodymyr Pylypchuk commented: "This latest study confirms our prior studies that the immunotherapy resulted in much shorter duration of treatment than among those who received standard ATT. While prior studies dealt with select clinical effects of Dzherelo they have not addressed certain clinical and laboratory parameters that we have investigated in the present study. The phytopreparation is definitely safe and even capable of reversing TB drugs-associated liver and kidney toxicity. In addition, Dzherelo reduces inflammation as evidenced by several hematological and biochemical markers. Sputum smear conversion rate has been significantly accelerated and enhanced as compared to standard ATT. When botanicals such as Dzherelo are validated through rigorous scientific and clinical research their integration into modern medical practice is more readily acceptable and treatment options for TB are expanded as a result."

This study was partially supported by financial support graciously provided by MAPI Research Trust, Lyon, France - a non-profit organization that advances the art and use of scientific methods to patient-reported outcome measures. This work was also presented in part at the Keystone Symposia on HIV Pathogenesis and HIV Vaccines, March 27 - Apr 1, 2008, Banff, Alberta, Canada, through grant from Bill and Melinda Gates Foundation's Global Health Travel Award.

About Ekomed
Ekomed is committed to the 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. The development of new therapeutic options for treating susceptible as well as MDR/XDR TB is the most effective way to decrease global morbidity related to HIV infection as well, since Immunoxel has been shown very effective in AIDS patients too. 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.