Kiev, Ukraine (PRWEB) September 10, 2008
Ekomed LLC has published Phase II clinical study of Dzherelo (Immunoxel) in 40 AIDS patients. The results appeared in Research Journal of Pharmacology.
In earlier published clinical trials oral immunomodulator Dzherelo (Immunoxel) has been shown to be very 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.
Dzherelo has been now evaluated in Phase II clinical trial in 40 HIV infected patients without TB, to evaluate its effect on immune and viral parameters. The control matched group of 20 patients received standard anti-retroviral therapy (ART) consisting of Zidovudine (AZT), Lamivudine (3TC), and Efavirenz (EFV). The intervention group of 20 patients received 50 drops of Dzherelo twice per day in addition to ART. After 2 months the total CD3 T-lymphocytes increased in ART recipients from 664 to 819 cells per microliter (P=0.06), whereas in Dzherelo recipients they rose from 595 to 785 cells (P=0.03). The population of CD4 T-cells was expanded by 57.3% in ART recipients (218 to 343; P=0.002) and by 93.5% in Dzherelo treated patients (184 to 356; P=0.004). The accrual in absolute and relative number of CD8+ lymphocytes in ART and Dzherelo recipients was 43.2% (2.7%) and 50.4% (-0.5%) respectively. The CD4/CD8 ratio in Dzherelo recipients had increased from 1.495 to 1.940 (P=0.03) but in the control group on antiviral drugs alone, the increase was not significant, i.e., 1.418 to 1.613 (P=0.14). About three-quarters (14/19) of patients on ART had shown decrease in viral load (P=0.008), while 95% (18/19) of patients on Dzherelo had shown reduction in the number of viral copies (P=0.001). Thus, Dzherelo had a favorable effect on immune status and viral burden in HIV patients when given as an immunomodulating adjunct to antiretroviral therapy. Results of this study were published in peer-reviewed Research Journal of Pharmacology (2008, Vol. 2, Pages 8-12, for access to full paper see at: http://www.medwelljournals.com/fulltext/rjp/2008/8-12.pdf).
"Present findings are consistent with the efficacy and safety of Immunoxel demonstrated in prior 36-weeks open label study in 70 AIDS patients, which was published in 2007," said Mr. Volodymyr Pylypchuk, scientific director of the Ekomed LLC. "Viral load reductions were shown in higher proportion of patients on Dzherelo, than among those on standard AIDS drugs. The increase in CD4 counts was about two-fold higher among those who had combination of Dzherelo and ART. What is remarkable is that patients who were in immune intervention arm had shown no toxic effects that are usually associated with use of ART. Dzherelo does not cure HIV or AIDS but odds of better clinical outcome are significantly better. We look forward to fostering lasting relationships with international researchers who might want to investigate independently the properties of Dzherelo."
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 for more than 15 years and continue unabated today. Ekomed began its HIV research back in 1998 and is one of very few botanical products companies that are committed to scientifically validated 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 pandemic, 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.
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 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 .
CEO and Scientific Director
pylypchuk @ bk.ru
Dr. Allen Bain
Zodiac Capital Limited
allen.bain @ zodiaccap.com