High Success Rate in Immunotherapy Trial of TB/HIV 'Deadly Duo' Infection

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Adjunct immunotherapy with herbal supplement Immunoxel (Dzherelo) combined with first-line TB drugs resulted in clearance of Mycobacterium tuberculosis in sputum cultures: 67% vs. 16% patients treated with TB drugs alone, with average time to negative culture 4 and 6 months respectively. Immunoxel, given at 50 drops twice-per-day dose, resulted in higher healing rate of cavitary/miliary involvements - i.e. 60%/84% in Immunoxel patients and 25%/46% in ATT alone patients. Immunotherapeutic intervention produced significant positive changes in body weight: 5.8±2.6 kg gain vs. 0.6±2.4 kg loss in ATT only patients. The incidence of opportunistic infections reduced in ATT + Immunoxel patients - 3 episodes vs. 12 episodes in ATT alone patients. This study appeared in British journal Immunotherapy (July 2009, Vol. 1, No. 4, Pages 549-556 - see link to the abstract at - http://www.futuremedicine.com/doi/abs/10.2217/imt.09.25

Ekomed LLC announces the publication of breakthrough study results showing high cure rate of TB patients co-infected with HIV who received its immunomodulator Immunoxel (Dzherelo). The study appeared in the July issue of Immunotherapy - published by Future Medicine) - a division of London, UK, based Future Science Group (http://www.futuremedicine.com/loi/imt).

In published clinical study, antiretroviral drug-naïve, TB/HIV co-infected patients with active pulmonary TB, were divided into two arms A (n=20) and B (n=20) to receive first-line anti-TB therapy (ATT) alone or ATT + Immunoxel respectively. At the end of study, 3 (16%) versus 12 (67%) (p=0.003) patients had Mycobacterium tuberculosis culture conversion, with time to negative culture 6 and 4 months in arms A and B respectively. In the ATT alone arm the healing of pulmonary cavitations was observed in 25% of patients at weeks 24-28, while 60% of individuals in arm B healed at 16-18 weeks (p=0.025). The TB lesions, on chest X-ray, had cleared in 46% in the ATT arm and 84% in the Immunoxel arm, with time to clearance 24-28 and 16-18 weeks respectively. In the ATT alone arm the body weight at baseline was 64±6.3 kg, with 13 cachexic patients who had an average weight deficit -5.2±1.7 kg. At the end of 6 months of follow-up they have lost an additional 0.6 kg (-5.8±2.4). The study entry level weight in arm B was 52±5.7 kg, with 12 individuals who had body mass deficit -8.5±2.7 kg. The Immunoxel intervention increased body weight by an average 5.8±2.6 kg above baseline (p<0.0001). The inclusion of Immunoxel into the ATT regimen decreased the incidence of new opportunistic infections with 3 episodes of infection versus 12 in arm A (p=0.003). These findings demonstrate that Immunoxel can significantly enhance the clinical efficacy of conventional tuberculosis drugs in difficult to treat TB/HIV co-infected patients.

The success in treating HIV with currently available antiretroviral therapies is now at peril because of increasing rates of tuberculosis in AIDS patients. Similarly TB drugs are not effective in treating tuberculosis patients with HIV co-infection. The number of new TB cases has tripled in high HIV-prevalence countries and today TB is the number one killer of people with HIV in the developing world. The drugs, diagnostics, and vaccines used to combat TB are outmoded. The TB mycobacterium is becoming more resistant to standard medications. The convergence of TB with AIDS is now a major global health challenge since no new or effective drugs are available that can adequately treat this deadly combination.

Director of Ekomed, Mr. Volodymyr Pylypchuk said: "Many people in rich countries think of tuberculosis as a disease of the past. Many experts thought that TB will be eradicated by now. But with around nine million new cases appearing every year, tuberculosis has come back with a vengeance. TB is a deadly killer, responsible for nearly two million deaths every year - that's almost four lives claimed every single minute. Today, TB is a global emergency that when combined with HIV - the two diseases represent an almost impossible to treat lethal condition. We are extremely satisfied to see that our Immunoxel can be successful against the so-called "deadly duo". Our partner, Stirling Products, is working closely with us to introduce our products to the global market that has many unmet needs".

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 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. For more information, visit http://www.ekomed.com.ua

About Stirling Products
Stirling Products is an Australian listed (ASX: STI) healthcare company focused on the development and commercialization of a unique portfolio of developed products as well as an exciting pipeline of future products (http://www.stirlingproducts.net). Major health issues and diseases being targeted by Stirling's products include: obesity, cholesterol disorders, diabetes, influenza, allergies, TB and TB/HIV co-infection. Stirling's animal healthcare division is focused on the manufacture and sale of its ProValeā„¢ beta-glucan product and the development and marketing of its beta agonist growth promotion agent. The Company is headquartered in Sydney, Australia and currently has operations that are rapidly expanding either directly or through joint ventures, partnerships or distributors globally. Last year Ekomed has established a global marketing partnership that is now managed through Stirling Products. This relationship will assure worldwide global access to the range of Ekomed products, including Immunoxel, especially for those who have limited or no treatment options.

For further information contact:

Volodymyr Pylypchuk
CEO and Scientific Director
Ekomed LLC

Peter Boonen
Managing Director
Stirling Products Limited


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