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Technology Overview Alphasporin™ ABOUT OUR PRODUCTS Alphasporin™ is an entirely new medicinal agent,. This agent was developed in response to the increasingly urgent need to treat the worldwide threat of viral epidemics, as well as to the increasing occurrence of antibiotic-resistant organisms. We believe Alphasporin™ is a major breakthrough in therapeutic medicine and its broad efficacy brings a new understanding of the human immune system and our natural disease fighting mechanisms. The most broadly successful therapy for human disease is provided by our own immune system. This includes all infectious, neoplastic, and autoimmune diseases. An intact and functioning immune system maintains a disease-free state, while a suppressed or dysfunctional immune system leaves us susceptible to a wide spectrum of maladies, almost without restriction. The process by which Alphasporin™ acts as a microbicidal agent is best explained through the understanding of the Respiratory Burst; the natural way our bodies fight microbes and tumor cells. White blood cells produce high-energy bio-oxidants, to kill viruses, fungi, and bacteria and to modulate immune function. Through significant in-vitro, pre-clinical and clinical research studies, Immune Technologies has demonstrated that Alphasporin™ augments this natural process. SAFETY AND TOXIDITY STUDIES Alphasporin™ is a safe and non-toxic substance. The safety profile was performed over a period of 6 years between 1988 and 1994 in four laboratories located in the United States, Cuba, and Kenya. Three of the facilities were medical academic institutions (University of California Irvine, Kenya Medical Research Institute, and University of Cuba, La Habana ) and the fourth was a professional contract research organization located in California. 19 different safety and toxicity studies were performed including: Minimum Inhibition Concentration assays, Minimum Bacterial Concentration assays, acute systemic toxicity, dermal toxicity, oral toxicity, ocular irritation, primary skin irritation, vaginal and rectal irritation, AMES Mutagenesis assays, Micronuclei in Mouse Bone Marrow, and other topical studies were performed in order to substantiate the effectiveness, safety, and tolerability of Alphasporin™. Of these 19 studies, a total of 312 mice, 65 rats, and 70 rabbits were used in order to substantiate the safety of the product. The following includes a summary of important results.
THE
CLINICAL INVESTIGATOR
Davy Kiprotich Koech BSc, MS, PhD, Cbiol, MIBiol, FinstPM, SS, CuD (Hon.), OGW: Since 1989, Dr. Davy Koech has served as Chief Research Officer and Director of the Kenya Medical Research Institute. He is the author of 161 refereed journal publications in the fields of Leishmaniasis, Schistosomiasis, Malaria, AIDS, and numerous other diseases. He has performed research under numerous grants and programs with the World Health Organization's Immunology Research and Training Centre, served as a Fulbright-Hays Scholar/Pharmacologist at Duquesne University, Montefiore Hospital (Department of Neurosurgery), and Harvard University Medical School (Departments of Medicine and Biological Chemistry). Since 1988 Dr. Koech has served as a member of the World Health Organization's Regional Panel of Experts on AIDS and as a member of the International Council for Infectious Diseases. He was honored to receive the Presidential Award (State Investiture) of the Decoration of the Silver Star of Kenya (S.S.) in 1984 and the Presidential Award (State Investiture) of the Decoration of the Order of the Grand Warrior of Kenya in 1989 both in recognition of distinguished service rendered to his nation. Dr. Koech is a member of Who's Who in Science and a member of the International Who's Who in Medicine. Dr. Koech was also honored to receive the Medal of Honor commemorating distinguished lifelong achievements from the American Biographical Institute in 1987. Dr. Koech received his BSc (Chemistry & Zoology) from the University of Nairobi in 1974, his MS (Pharmacology - Majored in Clinical Pharmacology) from Duquesne University in Pittsburgh, PA in 1977, and his Ph.D. (Medical Pathology, Immunology) from the University of Nairobi. Dr. Koech is a member of the East African Society of Parasitologists, British Society for Immunology, British Transplantation Society, Institute of Biology (U.K.), Institute of Professional Managers and Administrators (Fellow), Britain, International Society of Infectious Diseases, Association of Physicians of East and Central Africa, and Kenya Association of Clinical Pathologists.
CLINICAL TRIALS Determination of Efficacy and Safety of in the Management of Patients with Rheumetoid Arthritis, In this study, a total of 46 patients with symptoms and signs of rheumatoid arthritis screened. Out of these, 30 patients were enrolled into the clinical trial. at 200mg given in four divided doses daily were given sublingually foe 12 weeks. Eight out of 46 patients are currently on the topical application of while 15 out of 46 patients have not returned for their results. This report includes patients on the oral medication only. 30 patients with a clinical diagnosis of RA were enrolled after fulfilling the prescribed inclusion criteria. Efficacy and safety will be assessed as defined in the protocol. The patients will be followed up for a total of two months after completion of therapy. This study involves a two week hospitalization. In this regard the choice of the dates for the patients to check in is dependent largely on the individual patient's work schedules or programs. So far, 17 patients have completed three month follow-up while 15 of them have completed four month follow-up. There has never been any recurrence of the clinical disease during the period under study. There has been a consistent response: alleviation of pain within one week of hospitalization and commencement of therapy and sharp reduction of inflammation at the affected areas. On admission, the major majority of patients presented themselves with chronic active painful joints associated with swellings in the joints. They were unable to move the joints. In the majority of them, edema cleared by day 5, pain subsided and they were able to move the joints. So far, subsequent follow-ups have shown that the treatment was able to sustain pain free status. The data so far obtained indicate that when administered at 200mg/day oropharyngeanlly in four divided doses was found to be effective in the management of patients with mild to moderate rheumatoid arthritis. Patient with mild disease tended to respond faster and better. NO adverse effects have been observed. CLINICAL STUDIES OF Alphasporin™ ON TOPICAL DISEASES
IN VITRO AND IN VIVO STUDIES Direct activity of was assessed in vitro using cells, protozoa, bacteria and fungi. The product was dissolved in propylene glycol to give 250 mg/ml as a working a concentration and further diluted in the culture in which the particular organism was grown. Solvent alone and where possible, standard drugs and reference stains were used as controls. At dilutions of less than 1:2x10°, a myeloma cell line (x63 balb/c line) was killed within 48 hours and human spermatozoa were killed within 1 minute. Direct biological activity of was tested on microorganisms which cause common infections in the community; and the activity was assessed on the basis of minimum inhibition concentration (MIC) as well as minimum bacterial concentration (MBC) after the standard overnight incubation period in culture. The results are summarized in Table 1. From the Table, it is evident that, standard microorganisms that have been identified as resistant to conventional antimicrobials have uniform sensitivity to in the same manner as are sensitive organisms. Those isolates known to be resistant to antibiotics are Staphylococcus aureus (ATCC 25923), Pseudomonas aeruginosa (ATCC 27853) and Escherichia coil (ATCC 25922). The antibiotics used in the screening were penicillin, ampicillin, tetracycline, erythromycin, streptomycin, kanamycin, gentamycin, chloramphenicol and sulpharmetrol. The solvent or any stabilate, did not inhibit the in vitro growth of bacteria, fungi and protozoa used in the studies. These observations indicate that Alphasporin™ is more active than conventional drugs against commonly encountered microorganisms (in vitro) such as those causing common infections as diarrhea (Salmonella spp, Shigella spp, enteropathogenic/ enterotoxigenic Escherichia coli), urinary tract infections (Neisseria gonorrhoea, Candida spp), respiratory tract infections (Klebsiella spp, Staphylococcus spp, Phialophora spp, Penicillium spp) and protozoal infections (Leishmania spp). These microorganisms were uniformly sensitive to Alphasporin™ and the activity of the product on these microorganisms tested has no relationship with the resistance and sensitivity of conventional antibiotics on both gram positive and gram negative bacteria. It is important to note that some of the pathogens investigated are those that are routinely encountered in HIV-associated disease. Minimum inhibitory concentration of on highly resistant common pathogens:
N = Number of isolates tested; MIC = minimum inhibition concentration; EPEC/ETEC = enterpathogenic Escherichia coli/enterotoxigenic Escherichia coli; ND = not done. * Standard reference organisms known to be resistant to conventional antibiotics. These are strain ref. ATTC-25923 (S.aures), ATCC-27853 (P.aeruginosia) and ATCC-25922 (E.coli). CLINICAL SIGNIFICANCE On the basis of its tolerability in mice, the amount required to clear common pathogens in vitro and on the basis of observations made, Alphasporin™ is considered of high clinical potential and significance. Using appropriately formulated forms, Alphasporin™ has great potential in the clinical treatment and management of infections caused by the microorganisms tested in vitro. Minimal inhibitory concentrations of vs standard antibotics on bacteria & fungi in Vitro and in Vivo Studies:
Minimal inhibitory concentrations of Alphasporin™ on common viral pathogens:
IMMUNOMODULATORY ACTIVITY A group of 15 balb/c mice which had been used as negative controls (with but without infection) in the previous experiments on Leishmania infection were studied further to assess the effect of on the immunological status of these mice. Bone marrow examination revealed that there was an increase in new clones of lymphocytes in mice put on KE-091/ ATX as compared to mice without any drug or those with Pentostam alone. This observation strongly suggests that is an immunomodulator, a property which is of critical consideration in the treaAlphasporinent of diseases in an immunocompromised host and of autoimmune disorders. Studies in this area are still continuing. WHAT LEADING SCIENTISTS SAY ABOUT ALPHASPORIN Dr. Davy K. Koech, BSc., MS, PhD., Cbiol., MIBiol., FinstPM., CuD (Hon.) OGD, Specialist Immunolgist, Chief Research Office & Director Kenya Medical Research Institute (KEMRI) One of the worlds leading immunologist and head of a major government sponsored infectious disease research center. Dr. Koech is the author of over 161 publications in peer review journals and is the author and/ or editor of 6 textbooks in the field of infectious disease. Direct biological activity of Alphasporin™, an oxygen derivative, was assessed in-vitro and in-vivo. The product was found to be uniformly active against all organisms tested. In addition, it is active against certain tumor cells and protozoans and is also an immuno-modulator. On the basis of observations made, Alphasporin™ is considered of high significance. The product is also of clinical importance in considering new avenues in the treatment of various forms of Leishmaniasis, auto-immune disorders and symptoms associated with viral and infectious diseases. "The treatment for Rheumatoid Arthritis is the best products we know of globally!" Joseph V. Bannister, B.Sc., PhD., Oxford Distinguished Professor of Biochemistry, Department of Biomedical Sciences, Faculty of Medicine and Surgery, University of Malta. Dr. Bannister is the worlds leading scientist in the field of oxygen metabolite research and is the author of over 187 publications in peer review journals. The following excerpts are from a comprehensive report on Alphasporin™ by Dr. Bannister. "It is clear that the body utilizes oxygen radicals as defense mechanisms and to boost immune function." "Alphasporin™ is a potent anti-infective and will increase the efficiency of the immune system to kill invading micro-organisms." Dr. Mawull Kofi-Tsekpo, Chief of pharmacology - Kenya Medical Research Institute: "There is no doubt that Alphasporin™ works, and I believe that it is revolutionizing pharmacology." WHAT SCIENCE SAYS ABOUT OXYGEN AND IMMUNE FUNCTION Immunology, An introduction - Second Edition. Lan R. Tizard. Saunders Publishing. "Respiratory Burst" Of more importance in protecting animals are the neutrophis oxidative bacteriacidal mechanisms." Immunological Diseases - Forth Edition Max Sampler, M. D. Editor Little Brown & Co. "Oxygen is required for optimal microbicidal activity of phagocytes." "The superoxide system is toxic to many micro organisms including: bacteria, fungi, viruses, mycoplasma, Chlamydia, leishmania, trypansoma, schistosoma, and can inactivate soluble mediators and chemo-attractants (cytokines and interleukins). The peroxidase system can stimulate certain cells to release serotonin and prostaglandins. Thus the system has a physiological role as well as a microbicidal role." New England Journal of Medicine Vol. 298-#12 "Oxygen Dependent Microbial Killing by Phagocytes." The respiratory burst describes a metabolic pathway whose function is to produce a group of highly reactive microbicidial agents by the partial reduction of oxygen. The purpose of the respiratory burst is to provide a battery of oxidizing agents that can be used by the phagocytes for the destruction of microorganisms. Alphasporin™ is a government approved medication in 28 countries, however, Alphasporin™ has not been evaluated by the US FDA and is not intended to diagnose or treat any disease in the United States. About
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