Vancouver, Canada (PRWEB) March 21, 2012
TB is a global killer. About 2 billion people or 1/3 of the global population is latently infected with Mycobacterium tuberculosis. Annually, nearly 9 million of these people develop active TB and 2 million die. Current tuberculosis drugs are more than 40 years old and must be taken for six to nine months for drug-sensitive disease and up to 24 months for drug-resistant strains such as MDR-TB and XDR-TB. As new TB drugs currently under development will be not available in near future, new approaches are urgently needed. One of them is immunotherapy, which is believed to enhance the efficacy of chemotherapy and can potentially shorten treatment duration. Multi-herbal immunomodulator Immunoxel (Dzherelo), manufactured by Kiev-based botanical company Ekomed, has been sold in Ukraine for the last 15 years. The herbal tincture is widely available in Ukrainian pharmacies as a concentrated water-alcohol extract of medicinal plants and has been used in that country as an immune adjunct to TB and HIV therapy. More than a dozen clinical trials were published over the past 10 years showing its safety and efficacy in about 1,200 TB and HIV patients. This extensive experience can be summarized as follows. Typical sputum conversion rate among MDR, XDR and TB/HIV patients after 2-4 months of herbal immunotherapy was in 85-100% range, but in chemotherapy controls it took 6-24 months to reach 48-85%. While these results are clearly in favor of Immunoxel, they are not ideal, since the duration of adjunct treatment is still not optimal and faster-acting regimens will be more advantageous. In order to overcome this drawback solid, sublingual formulations of Immunoxel were made and tested clinically to see if they performed better than original liquid formula.
The study was conducted in Ukraine by leading experts in the field of TB immunotherapy in collaboration with investigators from Ekomed, Immunitor and Island Abbey Foods Ltd., (dba Honibe®) companies. Four types of solid sublingual formulations of Immunoxel were manufactured: sugar dragées, sugar-coated pills, gelatin pastilles and dried-honey lozenges. They were administered once daily along with TB drugs. After one month, 84.1% of TB patients became sputum-negative with conversion rates in individual groups of 89.5, 70, 76.9 and 100%, respectively. There was no difference in outcome between patients with newly-diagnosed TB, re-treated TB, MDR-TB and TB/HIV. The conversion rate was also independent from body weight, age, gender or differences in chemotherapy regimens. Other beneficial effects were earlier clinical improvement; faster defervescence; enhanced weight gain; higher hemoglobin content; and potent anti-inflammatory effect as evidenced by normalized leukocyte counts and erythrocyte sedimentation rate. In contrast, the conversion rate in the control group receiving sham or placebo sugar pills along with TB chemotherapy was only 19%. These findings indicate that mucosal delivery of solid Immunoxel is clinically superior to the original liquid formula. This study was a part of the project titled “Immunotherapy of tuberculosis” supported by the Civilian Research & Development Foundation (CRDF) - a non-profit organization authorized by the U.S. Congress and established in 1995 by the National Science Foundation.
The evaluation of clinical results in the context of commercial feasibility of product manufacture resulted in two choices. One is a simple sugar-based tablet and other dried-honey lozenge. Sugar-based tablet is cheapest and simplest delivery vehicle. This formulation, however, needs to be improved, which will be achieved by adding excipients such as those found in slow-release tablets. On the other hand, dried-honey lozenges with Immunoxel, which produced in this study 100% conversion, may be more attractive than sugar pills. This formulation is unique and it has been developed by Canada-based Island Abbey Foods Ltd. (dba Honibe®) according to their proprietary technology (http://www.honibe.com). John Rowe, the original developer of award-winning pure dried-honey formula said, “We do not know whether this outcome was random or higher effect was due to synergy with honey. The antimycobacterial activity of honey has been known since ancient times. Several in vitro studies demonstrated the direct inhibition of tubercle bacilli growth by honey. There are also published clinical studies showing its benefit in healing tuberculous lesions and counteracting the toxicity of TB drugs.”
“Remarkable anti-TB activity resulted from once-daily dose of solid Immunoxel. The goal of the study was to confirm our findings with original formula, and in so doing, we have developed an easy-to-administer tableted form of TB immunotherapy,” added Volodymyr Pylypchuk, Director General of Ekomed company (http://www.ekomed.com.ua).
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About Island Abbey Foods Ltd.
Island Abbey Foods Ltd. is a natural health product and specialty food producer based in Prince Edward Island, Canada. Honibe® (hon-ee-bee) brand honey is a line of all natural, specialty honey from PEI. Under Honibe® brand several products are offered including Honey Drop™, the world’s first 100% pure, no mess, non-sticky honey; honey candy Honey Delights™; granular honey Honey Sprinkles™ and Honey Lozenges™ for sore throat and nasal congestion relief.
Island Abbey Foods Ltd.
Lindsay Mulligan, Marketing Manager
Immune Network Ltd
Email: IMMFF at yahoo.com