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A Complex Homeopathic Preparation SCIENTIFIC INFORMATION 2017 Including Published Clinical Studies 1 ENERCEL® A proven complex Homeopathic preparation which activates both mitochondrial and non-mitochondrial energy pathways Enercel® has performed many scientific and clinical studies, and ceaselessly continues to prove its efficacy in ongoing clinical studies. Enercel® is also proving the extraordinary healing and curing effect of properly choosing and combining multiple singular homeopathic remedies. 2 INDEX Scientific Information of ENERCEL® - Overview Mechanisms of Action of Homeopathy ENERCEL® The Energy Medicine Cancer and Energy ENERCEL® and Stem Cells Undesirable Effects ENERPUNCTURE™ - A Combination of ENERCEL® and Acupuncture AIPT – Acupuncture Injection Point Therapy ENERCEL® STUDIES – PRE-CLINICAL ENERCEL®Formulation Testing: Anti-Aging Toxicity Tumors ENERCEL® STUDIES – CASE REPORTS Neurodegenerative and Neuropathies Metastic Squamous Cell Carcinoma – unknown primary Stage III left-side Breast Cancer Ureterovesicular Cancer ENERCEL® STUDIES – CLINICAL Particulars of Administration Allergic Diseases Allergic Origin Otorhinological Diseases Muscle Hydration Advanced Pancreatic Cancer ENERCEL® STUDIES – PUBLISHED BASIC SCIENCE - Therapeutic potential of KELEA activated Water - INT J COMPLEMENT ALT MED 1 (1):1-4 ANIMAL STUDY -Immunomodulatory Effects of a Homeopathic Agent - J NAT MED 5(6): 46-52 STUDIES IN HUMANS Tuberculosis–New-onset, Presumed Drug-sensitive & Multi-drug Resistant Pulmonary USAID – ISSN 2220-5071 – No 1 (08): 85-91 2012 Alternative Cellular Energy based therapy of Childhood Diarrhea Martin W.J. ACE & KELEA Activated Water 4 5 7 8 10 10 11 13 14 15 16 17 18 19 20 21 22 24 25 27 27 28 28 30 30 30 33 33 34 36 103-114 Significant Neurological Improvement in two patients with ALS using ENERCEL® J ACUPUNCT MERIDIAN STUD 4(4): 257-261 Stage IV Acquired Immunodeficiency Syndrome (AIDS) with co-infection Tuberculosis MEDCRAVE–Journal of Human Virology & Antiretrovirology Vol 2 Issue 6 - 2015 Stage IV Acquired Immunodeficiency Syndrome (AIDS) with co-infection Tuberculosis USAID – ISSN 2220-5071 – No 3 (18): 50-55 2014 Study in Detail Study Graphs ENERCEL® Contact Information and Associates 37 38 39 40 42 52 65 3 SCIENTIFIC INFORMATION of ENERCEL® OVERVIEW The energy enhancement in the tissues, results in improved function, health, metabolism and resistance to infection and stress. Once the energy of cells is normalized, particularly in the immune system, their health is restored and they are able to carry on their normal activities. ENERCEL® has been proven by in vitro, animal and clinical studies to significantly enhance the activity of Natural Killer [NK] cells. NK cells are an important part of the immune system; they provide first-line defense against many micro-organisms and cancers. NK cell activity is decreased by such factors as aging, environmental pollutants, chronic infections and trauma, and is restored by ENERCEL® use. ENERCEL® is a leading candidate to become our global first-line-of-defense against diseases for six essential reasons: 1. ENERCEL® works in a larger proportion of cases than any other system of health of which we know. 2. ENERCEL® is relatively inexpensive. 3. ENERCEL® helps the body heal itself rather than just relieving symptoms. 4. ENERCEL® does not produce the harmful side effects that are so common and unpredictable as with chemical medicines. 5. ENERCEL® works in combination with conventional medicine. 6. ENERCEL® is a leader in the new efforts for the field of Preventative Medicine. 4 MECHANISM OF ACTION of HOMEOPATHY Professor Luc Montagnier is a French virologist who co-discovered HIV and who won the Nobel Prize in 2008. Dr. Montagnier has received many other significant awards, though his newest research, which may explain how and why homeopathic medicines maintain their biological activity in extreme dilution, may be his most significant to date. In a recent paper, Prof. Montagnier and his team report the results of a series of rigorous experiments investigating the electromagnetic (EM) properties of highly diluted biological samples. The abstract of this research in part asserts, “A novel property of DNA is described: the capacity of some bacterial DNA sequences to induce electromagnetic waves at high aqueous dilutions. It appears to be a resonance phenomenon triggered by the ambient electromagnetic background of very low frequency waves.” The researchers used aqueous solutions that were agitated and serially diluted (the researchers note that the solutions were “strongly agitated” and that this step was “critical for the generation of signals”). The researchers also note that they used a device made by French immunologist Jacques Benveniste (the famous physician/scientist who conducted studies testing homeopathic dosages and whose work was initially published in Nature), and utilized all aspects of homoeopathy, although homeopathy is not mentioned anywhere in the article. Using the conventional homeopathic procedure in their testing, the researchers found that pathogenic bacteria and viruses show a distinct EM signature at dilutions ranging from 10 -5 to 10-12 [corresponding to homeopathic 5X to homeopathic 12X] and that small DNA fragments (responsible for pathogenicity) were solely accountable for the electromagnetic (EM) signal. 5 The researchers also noted that one experiment found significant effects from dilutions as high as 10-18 (equivalent to homeopathic 18X). The EM signature changed with dilution levels, but was unaffected by the initial concentration, and remained, even after the remaining DNA fragments were destroyed by chemical agents. Of additional interest was the researchers’ observation that they observed the same results whether their initial concentration of cells were just 10 or 109. They observed that the electromagnetic (EM) signal was destroyed by heating or freezing the sample (a common observation that homeopaths have found in their medicines). Also, a 'crosstalk' effect was found, whereby a negative sample inhibits the positive signal in another sample if they are left together overnight in a shielded container. The researchers propose that specific aqueous nanostructures form in the samples during the dilution process and are responsible for the EM effects measured. The Researchers also detected the same electromagnetic (EM) signals in the PLASMA, and in the DNA extracted from t h e PLASMA, of patients suffering from ALZHEIMER’S DISEASE, PARKINSON’S DISEASE, MULTIPLE SCLEROSIS, and RHEUMATOID ARTHRITIS. The researchers also quote Italian physicist, E. Del Guidice, the same scientist whom Benveniste cited, for positing that water molecules can form long polymers of dipoles associated by hydrogen bonds and that electromagnetic (EM) radiations they emit enable them to avoid decay. With this initial paper, Prof. Montagnier and his team have started a very promising line of enquiry, which has direct relevance to homeopathy as they continue to investigate the characteristic physico-chemical properties found in high-dilutions of biological material. Reference: Luc Montagnier, Jamal Aissa, Stéphane Ferris, Jean-Luc Montagnier, Claude Lavallee, Electromagnetic Signals Are Produced by Aqueous Nanostructures Derived from Bacterial DNA Sequences. Interdisciplinary Life Science (2009) 1:81-90 6 ENERCEL® – The Energy Medicine Energy Medicine is based upon the belief that changes in the "life force" of the body-- including the electric, magnetic, and electromagnetic fields—can affect human health, and can be manipulated to promote healing. Alternatively, a new concept of Energy Medicine embodies a network of under-differentiated, electromagnetically sensitive cells in the body that can be “triggered” by energetic substances to induce tissue repair and regeneration. The notion of a life force or energy is shared by people around the world. Since ancient times, traditional cultures have believed that a special energy vitalizes all life. This Energy has many other names. It is intriguing to consider that this ancient concept of Bio-Energy is now in the process of scientific definition as Stem Cell-like; electromagnetically sensitive cells in the body capable of cellular reconstruction and restoration. Over the course of the past three decades, Energy Medicine has moved from being a marginal area of research to gaining a large measure of mainstream acceptance. Despite over 300 studies during the past 40 years showing the efficacy of energy healing, these findings are still ignored or rejected by many scientists based on non-reproducible and inconsistent results. Distinct among modalities that improve and modulate energy in the body, ENERCEL® has proven to have reliable, reproducible, consistently positive results in clinical, animal and in vitro studies. ENERCEL® is a combination of homeopathic remedies as per the Homeopathic Pharmacopoeia of the United States (HPUS). ENERCEL® has been proven to be non-toxic and without negative side effects in patients both in clinical trials and general use. It is thought to work in the body by support of tissue and organ function via intra- and extracellular energy stimulation. 7 ENERCEL® activates the energy pathways of tissues throughout the body. The energy enhancement in the tissues results in improved function, health, metabolism and resistance to infection and stress. Once the energy of cells is normalized, particularly in the immune system, their health is restored and they are able to carry on their normal activities. Furthermore, since all tissues in a local area are affected in this way, homeostasis, not just of cells but between cells as well, is restored. When cells have sufficient and regulated energy, their function is modulated— when overactive, they quiet, and when underactive, they increase their activity. Overall, ENERCEL® enhances the substrate of cells of the body in order to re-set them for optimal function. In particular, the immune system is effectively regulated. The turn-over of immune cells in areas of infection, inflammation, oxidation and/or necrosis is intense. Homeostasis is difficult to achieve in such a milieu. ENERCEL® encourages self-modulation of immune function and the re-establishment of normal cellular, tissue and organ function. Symptoms of hypo- and hyperimmunity are reduced; infections are effectively fought; tissue damage is repaired; and both pain and inflammation are diminished. CANCER and ENERGY Within the human body, each cell registers an electrical charge across the cell membrane. Each cell’s interior carries a negative charge respective to the exterior charge. This electrical charge is referred to as the transmembrane potential. The magnitude of the transmembrane charge is different from cell to cell, ranging from about -50 to -70 millivolts. In cells that are excitable (chargeable), it can be even less than - 70 millivolts. Cancer cells are proven to contain low amounts of energy, have a reduced transmembrane potential, and a low level of cellular energy production. 8 The transmembrane potential in cancer cells is about -15 millivolts, indicative of extremely low energy levels. Such cells with low energy have a strong tendency to divide into two separate cells. The reason for this is quite simple: as the intra-cellular energy drops to low levels, the existence of the cell is threatened and it is at risk for apoptosis or cell death. The cell then begins to proliferate uncontrollably in an attempt to save itself. As these low energy, cancerous cells continue to rapidly proliferate, the amount of energy that is produced within the progeny cells is even further diminished. As one could imagine, the new cells that are formed have even more reduced levels of energy than the initial cancer cells. Cancer cells begin to form in an area of the body that is already low in energy levels. Researchers found a connection between mitochondria and cancer back in the 1930's. What was discovered was that mitochondria becomes dysfunctional in cancer cells. Based on research done at the University of Alberta, cancer growth can be hindered by facilitating the production of energy within the mitochondria. Early theories stated that the mitochondria in cancer cells are permanently damaged and not treatable. However, current research is now showing that damaged mitochondria can be restored, and when they are, there is a reduction in tumor growth. These findings point to dysfunctional mitochondria—and a resultant low-energy state—as a direct causal factor in the growth of cancer. These conclusions have been confirmed in both in vitro and animal studies. As normal energy production is restored in cancerous cells, they no longer feel threatened, and they do not proliferate uncontrollably in an attempt to ensure their survival. In turn, this process may arrest the proliferation of cancerous cells. ENERCEL® helps to restore normal mitochondrial energy production, raising the energy production of the cells and normalizing the transmembrane potential. 9 ENERCEL® and STEM CELLS Recent studies have suggested that a population of stem cells are electromagnetically sensitive. That is, certain electromagnetic frequencies [EMF] stimulate the proliferation of stem cells. Patents for the application of electric and/or electromagnetic frequencies to stem cells have been filed. Furthermore, preliminary studies have suggested that ENERCEL® —a potent homeopathic biological electromagnetic energy inducer—can prolong the life-span and induce proliferation of peripheral blood mononuclear cells [PBMC] and mesenchymal stem cells [private communication, Christner]. The highly diluted biological components of ENERCEL® appear to activate in vivo and in vitro electromagnetic signals. UNDESIRABLE EFFECTS ENERCEL® has no known toxicity—therefore, no specific laboratory studies are required. Testing should reflect the disease state itself and not the application of ENERCEL®. ENERCEL® has been used in a single dose up to 100 ml intravenously without side-effects. ENERCEL® has also been taken multiple times per day for many years without adverse effects. Any potential side-effects are related to the route of administration and not to ENERCEL®itself. ENERCEL® IV may result in bleeding, bruising, pain and risk of infection at the site of administration due to the incorrect administration by the practitioner. One-hundred & twenty-three children less than 5 years of age were enrolled in a placebocontrolled study of acute diarrhea disease. The test group received 3 ml of ENERCEL® IM twice daily for two total doses. No clinical signs of toxicity were noted. A single-dose study of ENERCEL® -- 50 ml intravenously-- was performed. No clinical or laboratory evidence of toxicity was noted. Eighty-two patients were treated with ENERCEL® Mist Nasal spray, 2 puffs three times/day for 1month. No adverse reactions were noted. 10 ENERPUNCTURE™ A COMBINATION of ENERCEL®and ACUPUNCTURE ENERCEL® and Acupuncture have been shown to be efficacious in a number of disorders due to stimulation and modulation of specific internal and external energy pathways. Preliminary case-reports suggest that the combination may be synergistic in supporting organ, tissue and especially immune system function, presumably through energy modulation. This report includes the effect of ENERCEL® and Acupuncture— individually and in combination—on neurodegenerative disorders and neuropathies. ACUPUNCTURE is a technique of traditional Chinese medicine, in which a number of very fine metal needles are inserted into the skin at specially designated points. For thousands of years acupuncture has been used, along with herbal medicine, for pain relief and treatment of various ailments. Today it is widely used in China in the treatment of hay fever, headaches, and ulcers, and some types of blindness, arthritis, diarrhea, and hypertension. Acupuncture is also used, especially in China, as a general anesthetic during childbirth and some types of surgery. Generally, in the practice of acupuncture, needles varying in length from 1/2 in. (1.27 cm) to several inches are inserted in appropriate points of the body, not necessarily near the affected organ. The needles are twirled and vibrated in specific ways; the depth of insertion also affects the treatment. Modern technique sometimes adds electrical stimulation applied through the needles. The traditional common acupuncture points are arranged along twelve lines, or regular meridians and as well as along eight extraordinary meridians. These meridians cover the entire body. The traditional Chinese explanation of the effectiveness of acupuncture is based on the Taoist philosophy according to which good health depends on a free circulation of chi (qi), or life force energy, throughout all organs of the body. The chi, in turn, depends upon a balance of the two opposing energies of yin (negative polarity) and yang (positive polarity). The meridians are the main channels of energy flow. When energy flow is impeded at any point [e.g. because of a diseased organ or stress] illness in other areas of the body may result. Piercing the channels at the proper points is credited to correct the imbalances. Western researchers have found that the acupuncture points correspond to points on the skin having less 11 electrical resistance than other skin areas. It has been suggested that acupuncture works by stimulating or repressing the autonomic nervous system in various ways, and there is some evidence that stimulation of the skin can affect internal organs by means of nerve reflex pathways. One theory is that acupuncture stimulates the release of natural pain-relieving chemicals called endorphins. Another is that it stimulates the pituitary gland, which in turn stimulates the adrenal gland to release anti-inflammatory chemicals. Since the early 1970s, acupuncture has gradually become more accepted in the northwestern hemisphere. Many areas now accredit schools of acupuncture and administer licensing examinations for non-physicians. Some physicians are studying and using acupuncture as an adjunct treatment. In the United States acupuncture has been used most often for pain control and drug and alcohol addiction. One impediment to total acceptance is the difficulty of fitting a traditional technique from another culture into the strict methods of scientific clinical trials customary in Western medicine. However, a number of clinical trials have suggested that Acupuncture is efficacious for a number or disorders including neurodegenerative disorders and neuropathies. Several studies have suggested that Acupuncture is beneficial in peripheral neuropathies. One study of acupuncture in treating diabetic peripheral neuropathy involved 60 participants. The study found that those receiving acupuncture had a statistically greater improvement in neurological symptoms as well as improved nerve function for both sensory and motor nerve conduction when compared to the control group. Another study conducted in Africa found that for the 126 patients that received acupuncture for diabetic peripheral neuropathy, 86% deemed the treatment as being effective for reducing symptoms in their hands and feet. In a 2006 Canadian study, acupuncture was utilized in five cases to reduce neuropathic pain in cancer patients. The acupuncture treatment was deemed effective in these cases where medication had failed. And finally, in a Chinese study involving 90 participants, those receiving total body, or wrist and ankle, acupuncture has significantly improved blood sugar and lipids, decreased blood viscosity, and improved functions of peripheral nerve cells, thus resulting in therapeutic effects for diabetic peripheral neuritis when compared to the control group. 12 AIPT – Acupuncture Injection Point Therapy The injection of liquid products into Acupuncture points—both drug and natural— is labeled Acupuncture Injection Point Therapy (AIPT) or Acupoint injection therapy. The treatment is based on the concept that products that enhance energy meridians may work synergistically with Acupuncture. Animal trials have validated the process in several models, including bee venom Acupoint injections for adjuvant-induced arthritis. Although few clinical trials are yet available, extensive experience in the community— especially in China—has yielded results beyond what may be achievable by Acupuncture, or the drug/supplement in question, alone. This practice is a recognized procedure in several states of the United States (Florida, Arkansas, Colorado, New Mexico, and Washington). The administration of ENERCEL® into Acupuncture points has been named ENERPUNCTURE™. This procedure has been of benefit for multiple patients with a variety of illnesses, most commonly musculoskeletal. Clinical experience to date has suggested that Acupoint injection with ENERCEL® (ENERPUNCTURE™) may improve outcomes for many disorders compared to Acupuncture alone. 13 STUDIES PRELIMINARY 14 ENERCEL® FORMULATION TESTING Jeunesse Anti-Aging Clinic PROJECT SYNOPSIS July 7, 2006 D. See, MD Background and rationale: Quality of life, disease prevention and slowing of the aging process depend upon healthy cellular, immune system, hormonal and other organ function. The number of bodily systems which need to be maintained in optimal function in order to ensure the best overall health possible is large. A number of supplements, dietary changes and other treatments would be necessary for optimal health unless a strategy of diffuse organ improvement could be achieved with one intervention. To this effect, the intracellular ACE inducer, Enercel®, was assayed for a number of markers of vigorous overall function. Purpose of study: 1) Validate the activity of Enercel® in 7 assays of cellular function 2) Determine the toxicity of the formulation. Methods: 1) 2) 3) 4) 5) 6) 7) Results: 1) 2) 3) 4) 5) 6) NK cell function assay Lymphocyte proliferation IGF-1 and HGH levels Anti-cancer test Cytochrome p450 assays Glutathione peroxidase Trypan blue toxicity assay to PBMC Enercel® had a 255% increase in NK function over no additive The PI was increased by Enercel® 94% over baseline Anti-cancer activity was increased by 362% Seven of nine cytochrome p450 isozymes had significantly increased activity with Enercel® addition The OD of glutathione peroxidase activity was increased by 74% There was no toxicity of up to 100µ/mg concentrations of undiluted Enercel Conclusions: Enercel® improved the activity of assays from several vital organ systems. Together, these systems comprise much of the bodily function needed for optimal health. In vivo correlation is needed, but Enercel® is a candidate for intervention in defective quality of life states and also such diverse conditions as fatigue, hormonal defects, Anti-aging protocols, chronic and acute infections, liver disease and more. Finally, Enercel® had no demonstrable toxicity, even when used undiluted. 15 TOXITY 1. In vitro - Toxicity See DM ENERCEL® at a dose of 100 µl/mg was applied to confluent monolayers of both MOLT-51 and K5622 cells. 5% ethanol was applied to control plates. Tissue culture media with fresh ENERCEL® at 100 µl/mg was added daily. The cells were observed for necrosis for three days. There was no toxicity (0 on a scale of 5). MOLT 5 cells are cells that are more stable than MOLT 4 cells. These are lymphoblast-like in morphology and are used for studies of apoptosis, tumor cytotoxicity, tumorigenicity, as well as for antitumor testing. K562 is an erythromyeloblastoid human leukemia cell line derived from a chronic myeloid leukemia patient in blast crisis. Recent studies have shown the K562 blasts are multipotential, hematopoietic malignant cells that spontaneously differentiate into recognizable progenitors of the erythrocyte, granulocyte and monocytic series. Cells are also used for hemoglobin synthesis, antitumor testing, tumorigenicity, differentiation, pharmacodynamics, cloning, cytotoxicity, cell biology, cellular effects of hyperthermia and natural killer assays. 2. Toxicity See DM Either placebo (5% ethanol) or ENERCEL® at a dose of 0.35 cc SQ was administered to 10 mice per group for 28 consecutive days. The animals were observed clinically each day for toxicity. There was no ataxia, lethargy or respiratory distress. After 28 days, sections of harvested brains, kidneys, livers, pancreases and hearts were examined for inflammation and/or necrosis. None was found. A repeat study using the same parameters was performed. Again, there was no clinical or Microscopic toxicity. 3. Clinical and microscopic toxicity See DM Mice were treated with 0.5 ml ENERCEL® IM daily for 30 days and evaluated for clinical and microscopic toxicity. There were no changes in color of the mucous membranes, hair, tail scaling, diarrhea, oral intake, movement, or posture. After sacrifice, internal organs were normal as to gross appearance, size, consistency, weight and blood vessels. Microscopic evaluation did not show any toxicity. 16 TUMORS 1. Breast Tumors See DM Rats with experimentally-induced mammary gland tumors were treated with ENERCEL® 0.05 to 1 ml IM/day. Control animals were given 1 ml placebo IM. No tissue necrosis was noted in biopsies from either group. 2. ENERCEL® In Vivo Studies on Experimental Tumors Bergoc RM, Rivera ES The efficacy of ENERCEL® in the treatment of induced mammary tumors in rats was evaluated. Escalating IM doses up to 1 ml/day for 10 days were assessed. After 10 days, the animals showed a clear improvement in their general wellness as manifested by greater mobility, friskiness and an increase in body weight as compared to placebo treated controls. Tumor growth was arrested, and sometimes regressed, in a high proportion of lesions in the treated rats. Some tumors developed a characteristic central lesion consistent with tumor breakdown on histopathologic specimens. Statistical evaluation demonstrated that the survival of the test animals was significantly greater than that of the controls (p<0.01). The clinical and pathologic benefits of ENERCEL® were dose-dependent. There was no difference in end points between animals treated with low-dose (0.05 ml/day) ENERCEL® than in untreated controls. Thus, ENERCEL® treatment was beneficial in a rat model of induced mammary tumors in a dosedependent fashion. All but the lowest dose was successful. Tumor regression, improved clinical signs and greater survival were observed in treated animals compared to no response in placebo treated ones. 17 STUDIES CASE REPORTS 18 NEURODEGENERATIVE AND NEUROPATHIES ENERCEL® has been successfully used in the management of neurodegenerative disorders and neuropathies, individually and via ENERPUNCTURE™. CASE REPORT #1: A 40-year-old female suffered lower back trauma from a motor vehicle accident. Subsequently she developed progressive weakness in her lower extremities, numbness in both feet, calf and feet muscle atrophy and a clumsy gait. A spine MRI showed spinal stenosis. She underwent back surgery to repair the stenosis—this resulted in a slower progression of lower extremity neurological symptoms but no regression. She remained dependent on crutches. Two years later, she began ENERCEL® by oral, IM and sublingual routes and by subcutaneous injection at specific Acupuncture points (ENERPUNCTURE™). She showed slow improvement over a three-month period of daily administration of ENERCEL®. At the end of that time, she was able to walk without crutches and had normal sensation in her feet. CASE REPORT #2: A 70-year-old female developed right eye pain, swelling of the area around the eye and blisters on the forehead, which progressed over 3-4 days. A diagnosis of ophthalmic herpes zoster was made. She then began to suffer from right-side headaches, tingling, and pain over her eye consistent with postherpetic neuralgia. She began ENERCEL® Mist administration to her right eye every 2-3 hours as well as ENERCEL® intravenously (once daily) for 5 days. The swelling and eye pain began to quickly improve and then resolved. More significantly, her neurogenic headaches and supraorbital pain gradually diminished and then resolved over about 7 days. 19 METASTATIC SQUAMOUS CELL CARCINOMA NK is a 59-year-old male smoker with moderate alcohol intake who presented with swelling in his neck, weight loss and fatigue. A fine needle aspiration of an enlarged cervical lymph node showed a poorly-differentiated squamous cell carcinoma. CT scan showed enlarged lymph nodes in the right neck and a parapharyngeal mass on the left. That mass was biopsied and showed squamous cell carcinoma. He received the diagnosis of metastatic squamous cell carcinoma, unknown primary. He received chemotherapy with cetuximab and radiation therapy. He had severe mucositis, rash and weight loss and required a feeding tube. A follow-up PET scan did not show any glucose uptake. However, 4 months later a CT scan showed new pulmonary nodules. His pulmonary function tests and arterial blood gas tests were normal. He had a wedge resection which showed metastatic non-small-cell carcinoma, probable non-keratinizing squamous cell carcinoma. Given that his cancer was metastatic, any further planned medical therapy was to be considered palliative only. He did not receive any further radiation or chemotherapy. He had fatigue and difficulty swallowing solid foods. Six months later, he had lymph node and pulmonary recurrences and considered palliative chemotherapy versus other options. NK then underwent treatment with his MD in Atlanta, GA. He was placed on intravenous ENERCEL®, 10 days on then 2 days off for 3 cycles; oral ENERCEL® Max twice daily; ENERCEL® Nasal Spray two puffs into each nostril three times daily and ENERCEL® Mist 2cc via Nebulizer twice daily. He underwent detoxification with liver and colon cleanses, Vitalzyme, BRM-4, foot baths and one gallon of alkaline water daily. During the month with his MD, he stopped drinking alcohol and maintained a vegetarian, organic diet. He gained weight and had a better sense of well-being and increased energy. He reported that his skin “had better color”. Upon arriving home, the patient received a repeat CT scan. It was clear without adenopathy or pulmonary lesions. He was considered to be in full remission. He remains in remission on ENERCEL® Plus I.M. doses, ENERCEL® Max orally, ENERCEL® Mist Nasal Spray and ENERCEL® Mist Nebulizer. In addition, he continues with detoxification, alcohol and cigarette avoidance and an organic, sugar-free diet. He feels very well, and followup CT scans are continued every 6 months. 20 STAGE III LEFT-SIDE BREAST CANCER Patient WM, 55 y/o black female with Stage III left-side breast cancer. Before starting ENERCEL® [left], compared with after a short course of ENERCEL® (intravenous, oral and direct tumor injections), and minimal surgical debridement [right]: 21 URETEROVESICULAR CANCER Patient DG, 63 year old male with ureterovesicular cancer. 1. 2.19.10: Approximately 4 x 4 cm mass [representing transitional cell carcinoma] at the L posterior ureterovesical junction. 2. 5.18.10: Mass has grown to approximately 7 cm x 4 cm (volume 73 cm3) and compresses the bladder wall. Patient has been treated with Salicinium in the interim. 22 3. 8.12.10: Mass has decreased to approximately 4 x 4 cm after 6 weeks of treatment with ENERCEL® Plus I.V. [volume 34 cm3]. Patient reported passing blood and pieces of dead tumor in his urine during the first 2 weeks of therapy. This resolved, and now patient feels better than he has in years. Compression of the bladder wall has resolved. There are hypo-dense areas inside and along the edges of the mass, representing tumor cell breakdown and necrosis. The mass volume has been reduced by 53%. 23 STUDIES CLINICAL 24 PARTICULARS OF ADMINISTRATION DURATION OF THERAPY The duration of therapy of ENERCEL® products is variable, depending on specific conditions and response to treatment. Clinical response to ENERCEL® has been observed within 2-3 hrs. A study of acute diarrhea in children reported resolution of symptoms in the majority of recipients after just two IM doses, 12 hours apart. Patients with pancreatic cancer were treated for one year with ENERCEL® given by IM, sublingual and oral routes. For many chronic conditions, ENERCEL® has been used daily for years without side effects or toxicity. Up to 50 ml of ENERCEL® Plus IV has been given intravenously on a daily basis for prolonged periods of time in patients with more serious illnesses without adverse effects. It is recommended that, for severe disorders, ENERCEL® Plus IV be given ten consecutive days followed by two days of detoxification in cycles as determined by clinical status. RATE OF ADMINISTRATION ENERCEL® Plus IV- Intravenous once daily to every twelve hours ENERCEL® Plus IM – Intramuscular once daily to every twelve hours ENERCEL® Mist Nasal Spray – Intranasal three to four times daily ENERCEL® Mist Nebulizer – Aerosolized one to three times daily ENERCEL® Max – Sublingual/Oral two to four times daily ENERPUNCTURE™ - Subcutaneous injection – Once daily SPECIAL POPULATIONS Patients with kidney/liver insufficiency: There are no known adverse effects in patients with hepatic or renal disease. ENERCEL® has been extensively used in these populations without problems. No dosage interval changes are required. 25 ELDERLY PATIENTS Although the pharmacokinetic disposition of ENERCEL® in the elderly is similar to those seen in younger adults, there is no targeted clinical trial data about the safety and effectiveness of ENERCEL® in this population. Subgroup analysis of elderly subjects in clinical trials reveals a similar clinical response and lack of toxicity as in younger adults. ENERCEL® has been used in thousands of elderly patients in open-label use without side effects and with clinical efficacy ENERCEL® can be used safely and efficaciously in the elderly population. CHILDREN Children have used ENERCEL® chronically without toxicity or side-effects or developmental delays. These include children with severe illnesses such as pneumonia and copious diarrhea. A formal study of ENERCEL® at 3 ml ENERCEL® Plus I.M. every 12 hours for two doses in a Pediatric population failed to show any local or systemic toxicity. A study of ENERCEL® Mist Nasal Spray in allergic upper respiratory disorders included a large number of children without side effects. The ENERCEL® Plus I.V. route has been used in children up to 2 ml/kg/day-- again, no toxicity was noted. There are no known limitations on the use of ENERCEL® in infants and children. CONTRAINDICATIONS ENERCEL® has been used safely and effectively in patients with chronic diseases including; heart disease; renal insufficiency; liver disorders; immune deficiencies; autoimmune conditions; cancer; nervous system diseases and chronic infections. There are no known contraindications for ENERCEL®. 26 ALLERGIC DISEASES 1. ENERCEL®: A New Homeopathic Immune Enhancer Nasal Spray for Recurrent Allergic Disease of The Upper Respiratory Tract: A Preliminary Communique. Izaguirre RR A total of 30 cases, ages from 8 months to 82 years were enrolled. Each subject had the clinical diagnosis of recurrent allergic rhinitis, sinusitis and/or bronchitis. The protocol included a standard dose of two sprays of ENERCEL® Mist Nasal Spray in each nostril three times per day in patients above five years of age; one spray three times per day in patients between two and five years of age; and one spray twice per day for infants under two years of age. Clinical parameters followed were: sneezing, runny nose, nasal congestion, wheezing, hypertrophy of adenoidal tissues; infections and antibiotic use, cough, weight loss, fever, and frequency, duration and severity of relapses and the patient's sense of wellbeing. Subject response was graded from 1 to 4 on a clinical scale, with 1 being no response and 4 an excellent response. The use of ENERCEL® Mist Nasal spray favorably influenced allergic-originated upper respiratory tract recurrent disease with a score of 3 out of 4 (good) in 34.5% of the cases. Excellent results (4/4) were recorded in an additional 58.6% of subjects for an overall positive response in 93.1%. The clinical response was more pronounced in patients below 30 years of age. No adverse reactions were reported in any case. 2. Application of ENERCEL® Mist, a Homeopathic Nasal Spray, In Cases of Allergic Origin Otorhinological8 Diseases. Kereszti GO Eighty-two patients at an ENT (Ear Nose Throat) outpatient clinic were sequentially enrolled into the study. These subjects all had seasonal and perennial allergic rhinitis, confirmed with a prick test. The age of the patients ranged from 3 to 66 years. The number of patients under 14 years was 33 (39.3%), the number of adult patients were 49 (59.8%). Thirty-two percent (32%) of the patients had skin lesions and all patients had accompanying lower respiratory symptoms. One third of the patients were previously treated with other antiallergenic therapy. ENERCEL® Mist Nasal spray was delivered in 2 puffs, 4 times a day to both nostrils. 27 Subjects were seen 1 week and 1 month after the initiation of treatment, at which time clinical examinations were done. They were also questioned about their symptoms and possible side effects. The symptoms of allergic rhinitis (congestion, itching, dripping, tearing, eye irritation) showed significant improvement (p<0.01) at 1 week, and was maintained throughout the treatment. Some peripheral manifestations of allergies like atopic dermatitis and urticaria also improved. Obstructive airway symptoms (wheezing, coughing at rest and at exertion, shortness of breath) also improved significantly at 1 week on the symptomatic score index and it was maintained at one month. Can Wasted Muscle be Rehydrated and Functionally Enhanced? Hazlewood CF, Kereszti L In a pilot study, patients with atrophied muscles were injected with a Biological Response Modulator (ENERCEL® Plus I.V.). The solution was injected into the motor points of the atrophied muscles. Within 24 - 48 hours, the volume of the treated muscles was increased. Aspects of the Quality of Life in Patients with Advanced Pancreatic Cancer. Bertacchini C Eighty-seven patients with stage III or IV pancreatic cancer were enrolled in this trial. A questionnaire was devised to measure selective aspects of quality of life. A survival curve was analyzed; and group follow- up was for twelve months. Daily doses of ENERCEL® Plus I.M. 4cc were administered during the entire study period. Sublingual/oral doses (ENERCEL® Max) were also added for an additional 2.5cc administered in four daily doses. A significant, beneficial effect was noted on several clinical parameters: pain, appetite, nausea and vomiting, emotional state and physical function. Compared with historical controls with this stage and type of cancer, 1-year survival was significantly improved. Sixty subjects were still alive at 1 year. The results of t h i s study revealed that patients with advanced pancreatic cancer treated for 1 year with ENERCEL® had a significant improvement on selective aspects of quality of life and survival compared to historical controls. 28 STUDIES PUBLISHED 29 SCIENCE Printed materials and websites of natural and Homeopathic products are full of testimonials from patients who have benefited from their products. Which is good. However, claims based upon testimonials, although of high interest, are not recognized scientifically. What is the scientific value? Scientifically, benefit from a product is only accepted when it is published. Why is publication so crucial? Prior to being accepted for publication, the information is subjected to review, critically and rigorously, by independent experts in the field. Then, upon affirmative agreement of the products’ proven benefits and value, the information is sent for publication. Enercel® is scientifically proven. From 1995 through 2009, several preliminary studies were conducted to acquire knowledge if Enercel® may work clinically. The results were all promising. In 2010, at great cost, the company embarked on a policy of rigorously conducting studies which would be publishable. Enercel® is scientifically published. The studies ranged (like any pharmaceutical) from basic science, to animal studies, to studies in humans. Over the past 5 years, Enercel® has had proven benefit for a variety of illnesses in six published studies. No other single natural product has this accomplishment. Enercel® allows the science to speak for itself without making any claims. The science continues. Breast Cancer studies and Early HIV studies with Enercel® use only. 30 BASIC SCIENCE Martin WJ (MD) (2015) Therapeutic potential of KELEA activated water Int J Complement Alt Med 1 (1):1-4 “The amounts of drug prescribed are consistent with direct biochemical effects on the diseased cells. By contrast, homeopathy claims that sub-biochemical drugs. The amounts of drug prescribed are consistent with direct biochemical effects on the diseased cells. By contrast, homeopathy claims that sub-biochemical amounts of various drugs can also have specific beneficial effects. A different interpretation of homeopathy is offered in this article. It is that homeopathy does not have the specificity claimed by its proponents, yet can be therapeutic by enhancing the body’s alternative cellular energy (ACE) pathway. It is proposed that effective homeopathic liquid formulations are characterized by an enhanced kinetic activity resulting from the absorption of an environmental force termed KELEA (Kinetic Energy Limiting Electrostatic Attraction). Various diluted herbal tinctures are able to transfer KELEA into water; a process facilitated by succussion (repeated jolting). Once water is sufficiently activated it can then directly absorb KELEA from the environment leading to its further activation and to the potential energy transfer to added water. It can similarly be used to provide KELEA to the body’s fluids and, thereby, enhance the body’s ACE pathway. One example is the product Enercel°, a “homeopathic activator of the natural system immune”. As stated on their web site (www.enercel.com), Enercel® is effective in alleviating childhood diarrhea, asthma, arthritis, hepatitis C, tuberculosis, amyotrophic lateral sclerosis (ALS) and HIV. It also promotes wound healing without scarring and can be beneficial when used on plants. The author of this paper helped in the design and data evaluation of the childhood diarrhea study using Enercel® and has published the finding. Published details relating to the ALS study and to the tuberculosis study are also available. 31 ANIMAL STUDY See DM, Tilles JG, Bertacchini C. (1998). Immunomodulatory effects of a homeopathic agent. J Nat Med 5(6): 46-52. Either 5% ethanol placebo or Enercel® was administered to groups of adolescent CD-1 mice at a dose of 0.35 cc SQ daily for 28 days. None of the mice manifested any evidence of gross or microscopic toxicity (brains, kidneys, livers, pancreases, or hearts). Splenic Natural Killer (NK) function versus YAC-1 targets was significantly greater in mice treated with the homeopathic agent Enercel® (mean 103 +/- 10.9 lytic units [LU]; p<.05) compared to placebo (mean 81 +/- 7.4 LU). Groups of mice were treated with 21, 14, 7, or 0-day courses of Enercel® tincture or placebo. They were then challenged with 1 x 104 plaque-forming units (PFU) of a diabetogenic strain of coxsackie virus B4 (E2). Treatment was continued for an additional three days; then the mice were sacrificed. Titers of virus in the pancreas were significantly reduced in the homeopathic group that was treated for 21 days prior to viral challenge (mean [log 10] 3.14 +/- 0.79 pfu/mg; p<.05) compared to placebo (mean [log 10] 4.29+/0.90 pfu/mg). Thus, a homeopathic medication, Enercel®, increased NK function both in vitro and in vivo and was nontoxic to mice. In vivo antiviral activity was demonstrated, presumably through immune enhancement. 32 STUDIES IN HUMANS 1. Dubrov V, Dubrova T, Suhareva V, Christner D, Baiamonte J, Laurent D (2012). Efficacy of treatment with Enercel for new-onset, presumed drug-sensitive and confirmed multidrug resistant pulmonary tuberculosis. USAID/Ukraine, Tuberculosis, Lung infections and HIV. ISSN 2220-5071- No1(08): 85-91 2012 OBJECTIVE: To determine if the complex homeopathic medicine Enercel® is efficacious in short-term treatment of new-onset, presumed drug-sensitive and confirmed multi-drug resistant [MDR-TB] pulmonary tuberculosis [TB]. MATERIALS AND METHODS: Seven new-onset, presumed drug-sensitive pulmonary TB and eight MDR-TB patients were enrolled. They each had baseline AFB-positive sputum smears. Drug-sensitive patients were treated with Enercel® by intravenous, aerosolized, sublingual and intranasal routes for 30 consecutive days. MDR-TB patients were treated for 10 consecutive weeks. Endpoints included Chest X ray, sputum AFB smears and Quality of Life [QOL] evaluation as assessed by cough, energy, mood, appetite, night sweats, weight and ease of breathing. Safety of Enercel® was evaluated by complete blood count and liver function testing. RESULTS AND DISCUSSION: Seven of seven [100%] presumed drug-sensitive patients were sputum AFB smear negative after 30 days. The 7 patients also had significantly decreased infiltrates and cavitations by Chest X ray. QOL significantly improved in all 7 patients. Four of eight [50%] MDR-TB patients were AFB smear negative and 1 more [12%] had significantly less AFB-positive organisms after 10 weeks. Each of these 5 responders had significantly improved Chest X ray findings. QOL significantly improved in each of the 8 patients. There were no toxicity or side effects associated with Enercel® use. CONCLUSIONS: Enercel® was highly effective in a short time [30 days] for new-onset, presumed drug-sensitive pulmonary TB and 10 weeks for confirmed MDR-TB patients. There were no adverse events associated with Enercel® administration. Enercel® may be useful in improving outcomes, limiting mortality, improving general health, and reducing length of treatment in these populations. Finally, long-term medical costs to public health systems may be significantly reduced. Following is a copy of the USAID publication. 33 34 35 2. Izaguire RR, Guzman MR, Fuentes RC, Mena CE, Penate E et al. (2014) Alternative cellular energy based therapy of childhood diarrhea. In: Martin W.J, Stealth Adapted Viruses; Alternative Cellular Energy (ACE) & KELEA Activated Water. Author House, Bloomington IN. pp 103-114 Acute diarrhea is a major killer of children under 5 years of age in developing countries. Enercel® is a licensed energized water product that can provide a source of alternative cellular energy (ACE). Two intramuscular injections of Enercel® were administered as an adjunct to routine care to a randomized group of children (n=58) with acute diarrhea. Clinical progress was assessed during a 24-hour hospitalization period and again at 48 hours after hospital discharge. Compared to an initially well matched randomized control group (n=53), at 48 hours post discharge there were significantly fewer Enercel® treated children with persisting increased peristalsis (p<0.001), dehydration (p=0.0224), fever (p=0.0126) or continued multiple bowel movements (p=0.0035). Benefits occurred in both rotavirus antigen positive and negative children. Enercel® represents a class of ACE Water™ products that can provide an effective adjunct to the routine care of young children in developing countries with acute diarrhea. 36 3. Liang S, Christner D, Du Laux S, Laurent D (2011) Significant neurological improvement in two patients with amyotrophic lateral sclerosis after 4 weeks of treatment with acupuncture injection point therapy using Enercel. J Acupunct Meridian Stud 4(4): 257-61. Amyotrophic Lateral Sclerosis (ALS) is a progressive, uniformly fatal, degenerative disorder of upper and motor neurons without any current effective treatment. We report on two case-studies of patients with ALS treated with 4 weeks of Acupuncture injection point therapy using Enercel®. Two patients with advanced ALS were given Enercel® Plus IM 0.25 to 0.5 cc at specific Acupuncture points 5 days per week for 4 weeks. Patient #1 presented with flaccid paralysis of all 4 extremities and impaired speech and swallowing. By week 4, she had significant improvement in motor strength of all 4 extremities, R > L, and improvements in speech and swallowing. She did not continue Enercel Acupoint injections and had slow, progressive loss of neurological function during 3 months of follow-up. Patient #2 had significantly impaired speech and mild motor loss in both upper extremities and left leg. After 4 weeks, his voice had significantly improved to the point that his speech was understandable and his motor function had returned to normal. He continued Enercel Acupoint injections during the 3-month follow-up and the clinical improvement was retained. Thus, two patients with ALS improved after 4 weeks of Enercel® Acupoint injection therapy. Follow-up data suggests that ongoing therapy may be necessary in order to maintain the positive effects. This preliminary data merits further study and confirmation. 37 4. Dubrov V, Dubrova T, Christner D, Sanseverino S, Laurent D (2014). Elimination of Detectable HIV particles in the Bloodstream and Improved CD4 Count for Three Patients in the Ukraine Treated with Enercel® alone or Enercel® + Antiretrovirals for HIV and Standard Antituberculosis Therapy for Tuberculosis Co-infection. USAID/Ukraine, Tuberculosis, Lung infections and HIV. ISSN 2220-5071 No 3 (18): 50-55 2014 AIM: Human Immunodeficiency Virus Infection [HIV] causes progressive immune system destruction and eventually death from opportunistic infections. Combination antiretroviral treatment is effective and results in normal life-span of affected individuals but is limited by side-effects, cost and the development of drug resistance. This preliminary study was designed to evaluate whether the complex homeopathic immunomodulator Enercel® is of benefit in patients with HIV and Tuberculosis co-infection. METHODS: One patient was treated with Enercel® without antiretrovirals for 4 months on the following schedule: 50 cc IV twice daily for 1 month followed by 50 cc IV once daily for 3 months; 20 drops under the tongue twice daily; 5 cc via nebulizer once per day and 2 puffs into each nostril three times per day. Two patients were treated with Enercel® on the same schedule + antiretrovirals [Abacavir 300 mg twice daily; Lamivudine (3TC) 150 mg twice daily and Efavirenz 600 mg daily] for 3 months. All patients received standard anti-tuberculosis medication. RESULTS: At baseline, the patient on Enercel® alone had a CD4 count of 360 cells/mm3 and a viral load of 35,428 copies/ml. After 4 months of treatment his CD4 count was 458 cells/mm3 and his viral load was undetectable (<40 copies/ml) [>2 log10 suppression]. Both patients on combination therapy had significant increases in CD4 count and elimination of detectable HIV particles in the bloodstream [>4 log10 and >5 log10] after 3 months. There were no side effects or toxicity. CONCLUSIONS: Whereas the use of immunomodulators in HIV/AIDS has had variable results, Enercel® was safe and effective in 3 patients with Clinical Stage IV AIDS. This encouraging result is now being followed by a more extensive evaluation of Enercel® in HIV/AIDS. Following is a copy of this publication followed by the study in detail, for your in-depth information. 38 40 41 STUDY RESULTS Performed at the Regional Antituberculosis Hospital in Chernigov, Ukraine for Patients with Co-infection of HIV and Tuberculosis Efficacy of ENERCEL® for STAGE IV ACQUIRED IMMUNODEFICIENCY SYNDROME [AIDS] with CO- INFECTION OF TUBERCULOSIS in Chernigov, Ukraine Dubrov T*, Laurent D**, Christner D**, Deikoun N*, Dubrov V* * Regional Antituberculosis Hospital, Chernigov, Ukraine ** World Health Advanced Technologies, Ltd., Nassau Bahamas, Sarasota FL USA BACKGROUND OF STUDY ENERCEL® is a complex homeopathic medication that has been used successfully in the treatment of many infections including: a) drug-sensitive and multi-drug resistant tuberculosis b) hepatitis B and C c) diarrhea in children TUBERCULOSIS AND HIV ARE THE #1 AND #2 CAUSES OF DEATH FROM INFECTIOUS DISEASES IN THE WORLD. • Together as a co-infection, they result in a much more severe and rapidly progressive illness than either alone. • Both of them cause the immune system to work much less efficiently against the other. AIMS OF THE STUDY ® To evaluate ENERCEL’s efficacy in treating patients with HIV and TB co-infection • To evaluate improved immune system function (by measuring T-helper or CD4 cells) • To lessen or eliminate the amount of HIV virus in the bloodstream (HIV viral load) • To verify the elimination of tuberculosis in the lungs (sputum AFB smears and cultures) 42 Methods Used in This Study of 3 Separate Groups Group #1: ENERCEL® plus standard TB treatment, no antiretroviral medications [ARV] 1. 50 cc of ENERCEL® given intravenously twice per day for 1 month followed by once daily for 3 months 2. 7 cc of ENERCEL® via nebulizer once daily 3. 2 puffs of ENERCEL® into each nostril three times per day 4. 20 drops of ENERCEL® sublingually twice per day 5. Standard Tuberculosis medications (drug sensitive TB) Group #2: ENERCEL® plus standard TB treatment and ARV 1. 50 cc of ENERCEL® given intravenously twice per day for 1 month followed by once daily for 3 months 2. 7 cc via nebulizer once daily 3. 2 puffs into each nostril three times per day 4. 20 drops sublingually twice per day 5. Standard Tuberculosis medications (drug sensitive TB) 6. Antiretroviral medications which consist of 3 or more standard medications given for HIV infection Group #3: No ENERCEL® standard TB treatment and ARV 1. Standard Tuberculosis medication (drug sensitive TB) 2. Antiretroviral medications which consist of 3 or more standard medications given for HIV infection 3. No ENERCEL® All patients were evaluated by i. Sputum AFB smears and culture ii. HIV viral load (VL) iii. CD4 count iv. Quality-of-Life (QOL) v. Toxicity Quality-of-Life was assessed on a scale of 0 to 100, with 100 being severe incapacitation and 0 being perfect health. Toxicity was monitored by biochemistry panels and complete blood counts. 43 Following is this completed study as published September 28, 2015 in the Journal of Human Virology & Retrovirology, MedCrave. Volume 2 Issue 6 – 2015 Alternative Cellular Energy Based Therapy using ENERCEL® in Advanced AIDS Patients Co-infected with Tuberculosis and Treated in Chernigov, Ukraine Dubrov V, Dubrova T, Christner D, Laurent D, Martin WJ (2015) Alternative Cellular Energy Based Therapy using Enercel ® in Advanced AIDS Patients Co-infected with Tuberculosis and Treated in Chernigov, Ukraine Journal of Human Virology and Antiretrrovirology Vol 2 Issue 6 – 2015 44 45 46 47 48 49 STUDY RESULTS • FOR THE 9 PATIENTS WITH AIDS ON ENERCEL®ALONE Sputum AFB-smear and cultures: 100% of the patients treated with ENERCEL® became AFB-smear negative Indication: elimination of tuberculosis in the lungs • HIV Viral Load: Mean viral load counts decreased in all patients, from a baseline of 535,881 to 179,998 copies/ml at 4 months in 7 patients and 3 months in 2 patients Indication: a significant drop of 66% in the amount of HIV particles in the bloodstream • CD4 Counts: CD4 counts improved in 100% of patients, from a baseline mean value of 231.3 to a mean value of 376.1 cells/mm3 after 4 months in 7 patients and 3 months in 2 patients Indication: an improved immune system • Quality-of-Life (QOL): QOL scores improved from a mean of 47.3 at baseline to 14.1 at 4 months for 7 patients and 3 months in 2 patients Indication: better general health (lower number = higher QOL) • Toxicity: ENERCEL® was proven to be 100% non-toxic. Indication: 100% of these patients had terminal, Clinical Stage IV AIDS, yet there were no deaths during the study period. 50 INDIVIDUAL RESULTS ENERCEL® alone - without ARV Patient #1 - The sickest patient had disseminated herpes simplex at enrollment with a CD4 count of 60 cells/mm3 and viral load 130,811 copies/ml. a. Within 10 days, his herpes infection resolved; b. at 4 months his CD4 count had risen to 100 cells/mm3 c. and his viral load decreased to 10,957 copies/ml. Patient #2 Start: CD4 count of 66 cells/mm3 and a viral load of 397,187 copies/ml At 4 months: CD4 count of 111 cells/mm3 and viral load of 45,241 copies/ml Patient #3 Start: CD4 count of 358 cells/mm3 and a viral load of 41,603 copies/ml At 4 months: CD4 count of 404 cells/mm3 and viral load of 21,879 copies/ml Patient #4 Start: CD4 count of 61 cells/mm3 and a viral load of 294,136 copies/ml At 4 months: CD4 count of 139 cells/mm3 and viral load of 10,290 copies/ml Patient #5 Start: CD4 count of 481 cells/mm3 and a viral load of 177,879 copies/ml At 4 months: CD4 count of 532 cells/mm3 and viral load of 17,931 copies/ml Patient #6 Start: CD4 count of 233 cells/mm3 and a viral load of 2,674,129 copies/ml At 4 months: CD4 count of 581 cells/mm3 and viral load of 1,400,045 copies/ml Patient #7 Start: CD4 count of 360 cells/mm3 and a viral load of 35,428 copies/ml At 4 months: CD4 count of 458 cells/mm3 and viral load of <40 copies/ml Patient #8 Start: CD4 count of 345 cells/mm3 and a viral load of 181,619 copies/ml At 4 months: CD4 count of 370 cells/mm3 and viral load of 67,605 copies/ml Patient #9 Start: CD4 count of 112 cells/mm3 and a viral load of 378,233 copies/ml At 4 months: CD4 count of 247 cells/mm3 and viral load of 81,907 copies/ml ENERCEL® with ARV Patient #1 Start: At 3 months: Patient #2 Start: At 3 months: CD4 count of 87 cells/mm3 and a viral load of 630,073 copies/ml CD4 count of 338 cells/mm3 and viral load of <40 copies/ml CD4 count of 459 cells/mm3 and a viral load of 5,192,532 copies/ml CD4 count of 788 cells/mm3 and viral load of <40 copies/ml 51 ARV alone 1. One control patient on ARV alone had no detectable HIV particles in the blood, but his CD4 count did not change [baseline 28 cells/mm3 and after 3 months it was 29 cells/mm3]. a. Consequently, his AFB smear, which was negative at baseline, became positive at 3 months. 2. The second control patient had undetectable viral load, but his CD4 count did not change significantly [140 cells/mm3 at baseline and 152 cells/mm3 after 2 months]. a. He developed a high fever and died after 2 ½ months. It needs be noted here that 6 patients were evaluated and not enrolled into this study because of various exclusion criteria (including continuing alcohol and/or drug abuse). All 6 expired during the study period. ENERPUNCTURE™ Acupuncture injection point therapy using ENERCEL® Enerpuncture™ was used to treat 3patients: 1. One patient had a right-sided stroke from TB meningitis. She was treated with 4 months of Enerpuncture™ on her right upper and lower extremities. She is now able to move her right shoulder and arm and she can walk with a slight limp. 2. Another patient had HIV/TB nerve damage of his lower extremities to the point that he could not stand without support. He is now able to walk on his own with a cane. 3. Similarly, a third patient had bilateral lower weakness and walked with a cane; after 4 months, he was able to walk without support. 52 CONCLUSIONS 1. ENERCEL® is effective in eliminating tuberculosis in the lungs with a very short treatment regime. 2. ENERCEL® is a safe, low-cost, homeopathic medication that has shown preliminary efficacy in the management of HIV infection associated with tuberculosis. 3. As a result of utilizing ENERCEL®, Immune system function was improved, HIV in the bloodstream was markedly reduced and Tuberculosis was eliminated in the lungs. 4. Analysis of control patients suggest that antiretrovirals (ARV) are effective in reducing viral load in patients with very low CD4 counts, but they remain at risk for opportunistic infections and/or have a delayed or absent rise in CD4 count. 5. The addition of ENERCEL® to ARV treatment results in a rapid elimination of viral particles in the bloodstream and swift reconstitution of the immune system. THESE RESULTS ARE PARTICULARLY NOTEWORTHY FOR THE FOLLOWING FOUR REASONS 1) Co-infection with TB and HIV is much more difficult to treat than either infection alone. 2) Each enrolled patient had Clinical Stage 4 HIV/AIDS-- the MOST SEVERE STAGE and the most difficult to treat with standard therapy alone. 3) Elimination of TB from the lungs in a short time period will have a tremendous economic impact as well as reducing the chances of multiple drug resistant strains of tuberculosis. 4) This is the first study to show that a SINGLE medication - ENERCEL® - is able to effectively treat BOTH a severe VIRAL [HIV] and BACTERIAL [TB] infection SIMULTANEOUSLY. 53 This information has far reaching implications in the battle to control Tuberculosis, which remains one of the leading causes of death worldwide. The Centers for Disease Control and Prevention states: “TB in the United States reflects the global reality. TB is one of the most common infectious diseases worldwide. While significant progress has been made toward the elimination of TB in the United States, this disease remains an urgent public health problem in many other parts of the world. In 2013, 65% of all TB cases and 90% of multidrug–resistant TB cases in the United States occurred among people born in other countries. Nearly 50% of these individuals were born in just five countries Many of CDC’s global TB control activities are focused in these high-burden and origin countries. Investing in TB control in high-burden settings reduces TB cases in the United States, costs less than screening at U.S. entry points, and saves funds that would be spent treating TB disease in the U.S. CDC collaborates with other U.S. Government (USG) agencies, local ministries of health (MOH), multilateral organizations, and non-governmental organizations (NGOs) to build strong national TB programs. CDC plays an important role in finding the most effective ways to implement new tools and approaches in resource-limited and high-burden settings through clinical and operations research, technical assistance, program and policy design, demonstration projects, and program monitoring and evaluation. CDC focuses on supporting innovative approaches to screening, diagnosing, case-finding, and curing TB to stop the spread of disease and prevent development of drug resistance. TB is one of the world’s deadliest diseases: One third of the world’s population are infected with TB. In 2013, 9 million people worldwide became sick with TB disease, most of whom (80%) live inone of the 22 high burden countries for TB. TB is a leading killer of people living with HIV (PLHIV). “ 50 The highest numbers of deaths occur in patients with co-infection of HIV and Tuberculosis. The World Health Organizations DOTS (directly observed treatment, short course) has definitely improved results. However, because it requires the patient to take a complex combination of pills every day for 6-9 months, as well as have a healthcare provider to supervise the treatment during that time. The fact that the patient can experience significant side effects while taking this medication, many patients end the treatment prematurely. When patients stop taking the medicine and then start taking it again it leads to failed treatments and the greater danger of developing multiple drug resistant strains of tuberculosis. An earlier study completed with ENERCEL® and TB, both Sensitive and Multi-DrugResistant, suggests the addition of ENERCEL® to TB medications can eliminate TB in as little as 10 to 30 days instead of 6-9 months; resulting in a huge savings in the cost of treatment not only for the state (many countries have government programs funded to control TB), but also for the patient. Without the fear of spreading TB, patients are able to return to life with their family and friends and go back to work, while enjoying the benefit of an improved quality of life. IN SUMMARY ENERCEL® HAS BEEN SHOWN TO: 1. Eliminate TB in the lungs in combination with anti-TB medications; 2. Substantially improve the QOL of HIV patients; 3. Improve the immune system function of HIV patients; 4. Significantly decrease the viral load of HIV patients. The World Health Organization and many large foundations are focusing on developing treatment regimens that are shorter and easier to implement, as well as the treatment and reduction of HIV infections. ENERCEL® is their answer. 51 IMAGINE THE IMPLICATION OF THIS PRODUCT ENERCEL® CAN BE USED TO MORE THAN ENHANCE THE LIVES OF PATIENTS STRUGGLING WITH BOTH TB and HIV .. WITHOUT ADVERSE SIDE EFFECTS ! Following are graphs visually showing the progress of each patient. A picture is truly worth a thousand words. View and envision the possibilities. 52 52 53 54 55 56 57 58 59 60 61 62 63 64 Presented with respect and wishing you Good Health, The Enercel® Team Contact Information Website www.enercel.com EMail [email protected] Landline 1-941-927-3444 Fax line 1-941-927-3477 Information Mailing Address 2477 Stickney Point Road Unit 200A Sarasota, FL USA 34231 Associates President and Chief Executive Officer Sir David Christner, MD(MA), Ph.D. Executive Vice President Sir John Baiamonte, MBA Vice President - Laboratories Sergio Sanseverino Vice President – Veterinarian Division Jan Hale, DVM Director of Science Dariel Laurent, MD Director of Nursing & Executive Assistant Phyllis Kim, RN General Manager & Director of Admin Stephanie Du Laux, MD(MA), D.Ac., CAM World Health Advanced Technologies, Ltd. A Bahamian Corporation Sir David Christner, MD(MA), Ph.D. President and Chief Executive Officer 2017 DISCLAIMER ® ENERCEL is a homeopathic formulation manufactured in strict conformity with the Homeopathic Pharmacopoeia of the United States (HPUS). ENERCEL® is not FDA approved for any medical condition and no claims are made that it can treat, cure, mitigate or prevent any illness, other than as proven by Clinical Study. Sir John Baptist Baiamonte, MBA Executive Vice President