IAGIM - Drug Development Association

(Ongoing 2010 - 2025 - Fifteen Year GLIMER I, II and III MS Research Project Extended 2019)

Prof. J. D. Block - Epidemiologist
Chief Scientist IAGIM Institute and CEO LIGroup

Article of the Month"

Prof. J. D. Block - Neuro-Immuno-Epidemiologist (N.I.E.)

PART TWO - GLIMER I, II, III Multiple Sclerosis Breakthrough Research.
Part two of this ongoing review - will deal with the epigenetics and epidemiology triggers, such as early EBV immunization, Vit D3 (24-25 dihydroxy cholcalciferol), Normal sunlight exposure, combination food symbiosis of Vit D3 and Sunlight to produce 2000+ IU's of equivalent D3 every day. The right foods. Not 400 IU's but 2000+ IU's of intrinsic and extrinsic Vit. D3 daily and the proper daily ratios. The number of minutes of sunshine a young auto-immune developing child must be exposed to, is in the region of 22-35 min at day (weather depending), but not 8 min a day as is normal in Canada and much less in the Canadian Atlantic Region - eventually we will end with Oligodendrites and their fatal unavoidable mistakes (it's just a statistics game) together with the DNA indels and the statistical probability of DNA mutations (and their surprising causes) affecting the 3.2 billion lines of DNA code per global geographic region as a function of epigenetic and epidemiology. MS like polio, is a preventable disease, not through vaccinations, (not yet, but is coming, a new branch of medicine called retrospective-prospective didactic vaccines. RPDV's are just three to five years away, maybe eight at max., but in that overall ball game.) Yes, preventable with RPDV's to the pre-pubic age groups or very significantly reducible through RPDV's, with added proper educated lifestyles and serious educated nutrition to avoid relapses of the immune system. The emergence of the RPDV's are a new class of lymphocytes and leukocytes simulating vaccines. Stopping the boredom and mischief in the emerging white blood cells. This new class of RPDV's are going to be revolutionary and quite extraordinary - much like the emergence of the antibiotic arena but without the resistance as we can modify the training. It's really a bit like Glatiramer Acetate in a way - which is a red-herring vaccination but the upcoming RPDV's are the real McCoy, a new generation of teaching vaccines, without the undesirable side-effects of red-herring physiological chemistry (mimicry). The epigenics are getting quite clear now. We are getting closer to the light. We need to take care of the developing first three/six years of life, and develop a healthy immune system and keep it active and healthy for decades. Diet, sunlight and early EBV inoculating by "Mom method" are three early important triggers, but there are many more triggers we need to protect. We almost know the basic, underlying cascading etiology, how and when it all starts - that's no 'biggy' now- so many years ago in early child hood and definitely for quite sometime now - how it all is going to end.

Phase 1 trial safely resets patientsí immune systems, reduces attack on myelin protein January 4, 2015. CHICAGO --- A phase 1 clinical trial for the first treatment to reset the immune system of multiple sclerosis (MS) patients showed the therapy was safe and dramatically reduced patientsí immune systemsí reactivity to myelin by 50 to 75 percent, according to new Northwestern Medicine research. In MS, the immune system attacks and destroys myelin, the insulating layer that forms around nerves in the spinal cord, brain and optic nerve. When the insulation is destroyed, electrical signals canít be effectively conducted, resulting in symptoms that range from mild limb numbness to paralysis or blindness. ďThe therapy stops autoimmune responses that are already activated and prevents the activation of new autoimmune cells,Ē said Stephen Miller, the Judy Gugenheim Research Professor of Microbiology-Immunology at Northwestern University Feinberg School of Medicine. ďOur approach leaves the function of the normal immune system intact. Thatís the holy grail.Ē Miller is the co-senior author of a paper on the study, which was published Jan. 5th in the journal Science Translational Medicine. The study is a collaboration between Northwesternís Feinberg School, University Hospital Zurich in Switzerland and University Medical Center Hamburg-Eppendorf in Germany. The human trial is the translation of more than 30 years of preclinical research in Miller's lab. In the trial, the MS patientsí own specially processed white blood cells were used to stealthily deliver billions of Myelin antigens into their bodies so their immune systems would recognize them as harmless and develop tolerance to them. Current therapies for MS suppress the entire immune system, making patients more susceptible to everyday infections and higher rates of cancer. While the trialís nine patients -- who were treated in Hamburg, Germany -- were too few to statistically determine the treatmentís ability to prevent the progression of MS, the study did show patients who received the highest dose of white blood cells had the greatest reduction in myelin reactivity. The primary aim of the study was to demonstrate the treatmentís safety and tolerability. It showed the intravenous injection of up to 3 billion white blood cells with myelin antigens caused no adverse affects in MS patients. Most importantly, it did not reactivate the patientsí disease and did not affect their healthy immunity to real pathogens. As part of the study, researchers tested patientsí immunity to tetanus because all had received tetanus shots in their lifetime. One month after the treatment, their immune responses to tetanus remained strong, showing the treatmentís immune effect was specific only to myelin. The human safety study sets the stage for a phase 2 trial to see if the new treatment can prevent the progression of MS in humans. Scientists are currently trying to raise $1.5 million to launch the trial, which has already been approved in Switzerland. Millerís preclinical research demonstrated the treatment stopped the progression of relapsing-remitting MS in mice. ďIn the phase 2 trial we want to treat patients as early as possible in the disease before they have paralysis due to myelin damage.Ē Miller said. ďOnce the myelin is destroyed, itís hard to repair that.Ē In the trial, patientsí white blood cells were filtered out, specially processed and coupled with myelin antigens by a complex GMP manufacturing process developed by the study co-senior authors, Roland Martin, Mireia Sospedra, and Andreas Lutterotti and their team at the University Medical Center Hamburg-Eppendorf. Then billions of these dead cells secretly carrying the myelin antigens were injected intravenously into the patients. The cells entered the spleen, which filters the blood and helps the body dispose of aging and dying blood cells. During this process, the immune cells start to recognize myelin as a harmless and immune tolerance quickly develops. This was confirmed in the patients by immune assays developed and carried out by the research team in Hamburg. This therapy, with further testing, may be useful for treating not only MS but also a host of other autoimmune and allergic diseases simply by switching the antigens attached to the cells. Previously published preclinical research by Miller showed the therapyís effectiveness for type 1 diabetes and airway allergy (asthma) and peanut allergy. The MS human trial relates directly to Millerís recently published research in mice in which he used nanoparticles -- rather than a patientís white blood cells -- to deliver the myelin antigen. Using a patientís white blood cells is a costly and labor-intensive procedure. Millerís study showed the nanoparticles, which are potentially cheaper and more accessible to a general population, could be as effective as the white blood cells as delivery vehicles. This nanoparticle technology has been licensed to Cour Pharmaceutical Development Company and is in preclinical development. Millerís research represents several pillars of Northwesternís Strategic Plan by discovering new ways to treat disease in the biomedical sciences and translating those discoveries into ideas and products that make the world a better place for everyone. The research was supported by the German Federal Ministry for Education and Research and the Cumming

Jeremy David Block.
BSc. (Eng.), MSc.(WCU), (Micro/Stats UNISA), D.Pharm (Wits)., PHD (Neuro IAGIM. U.)
Part Three / - 2015/6. - Total Parts: 20 - Pages 110 and growing)

ALTERNATIVE MORE ADVANCED MS Article - ; Ref: "Article of the Month"
Prof. J. D. Block - Neuro-Immuno-Epidemiologist (N.I.E.)

Prof. J. D. Block served for the duration of the development of COP 1 as a senior medical/pharmaceutical researcher and part of the Teva COP 1 innovative research team in the early nineties that rapidly developed Teva's first MS immuno-modulating drug Glatiramer Acetate (CopaxoneTM). As Chief Scientist as well as Teva's Group Scientific Research Auditor, and by touching each and every part of the Teva's organization and the overall scientific team, Teva rapidly attained New Drug Registration with the FDA under J. D. Block scientific and technical guidance and regulatory department training, GRP, GMP GLP, SOPs, Analytical audits and global organization overview (from early active material synthesis to manufacture and then final freeze dried packaging).

Epidemiology Note*
ISRAEL Israeli Jews have a prevalence of up to 62 per 100,000, but Christians (35 per 100,000), Moslem Arabs (15), Druze (11), and Bedouins (17) have lower rates (Alter et al 2006). Genetically similar immigrants have half the rate of native-born Jews, suggesting an environmental factor. Other groups also have a significantly lower incidence of multiple sclerosis (Caucasians Hispanics Latino's black African Americans, Asians African Natives, Inuits, SWA bushman, and Romani Gypsies (almost zero)).

ALTERNATIVE MORE ADVANCED MS Article - ; Ref: "Article of the Month"
Prof. J. D. Block - Neuro-Immuno-Epidemiologist (N.I.E.)

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