Frequently Asked Questions about EmeraMeds’ lipophilic, blood-brain-barrier passing metal chelator and antioxidant Irminix® Please submit any questions that have not been answered through our contact form.
Approved drugs under development like Irminix® can be obtained through early access programs. Each country has it’s own system, called Compassionate use, Named patient use, individual patient IND’s, etc, depending on the country. The drug must be prescribed by a licensed professional who assumes the responsibility for the treatment and patient follow up. A patient cannot prescribe it. EmeraMed will assist the physician in this process. The approval process in the USA is more complicated than in other countries. In some countries, no approval is needed. This is described further at our Early Access page.
We do not charge for the drug but do charge €600 or $750 for a flat fee for insurance-shipping-administration per two-week treatment of 300mg per day (14-days x three 100 mg capsules per day).
It depends on what disease that you are treating and on how serious your condition is. There are people with mercury toxicity for which one round has been enough, while for others several treatments have been beneficial. There are people with COPD who have taken Irminix® for years as a mucolytic.
We think the answer is yes to all of the above based on laboratory studies and basic chemical knowledge. In humans, we have tested Irminix® on mercury. In animals, we have tested Irminix® on iron and lead. In vitro we have tested Irminix® on cadmium and arsenic. Our aim is to test the chelating capacity on all these metals in humans.
Irminix® has a tremendous anti oxidative capacity, binding free radicals intracellularly. Free radicals are the fundamental cause of oxidative stress and aging. Irminix® enters cells and scavenges free radicals eliminating them harmlessly through the urine, and reducing oxidative stress very rapidly. This leads to a favorable increase in intracellular reduced Glutathione, the body’s most important anti oxidant.
Irminix® has been found experimentally not to reduce normal essential minerals in the animal and human studies we’ve conducted to date. In some animal studies where they were fed more than 100 times the amount recommended zinc may have been somewhat lowered until the drug was stopped. Depletion of essential metals has not been seen in humans or animals taking the lower amounts needed to effectively treat heavy metal toxicity. The normal human dose is 3 to 4 mg/kg.
In three Phase 1 and 2a clinical trials, there have been no drug related adverse events. Between 2008 and 2010 2.5 million doses of the compound were sold through doctors and dentists offices with adverse event tracking. There were no drug related adverse events. US FDA demanded a halt of sales not due to side effects, which they have none reported, but due to considering the compound being a New Chemical Entity (NCE) needing to go through a drug development program before it could again be available, as a drug. That usually takes about 10 years and we are on schedule.
We have not yet conducted clinical trials in humans, but we have completed several trials in small rodents that are especially bred to suffer from genetically induced iron overload. In these test animals Irminix® reduced the iron content towards normal levels in the liver and brain, normalized the oxidative stress level in the brain, and improved the abnormal behaviour of these animals induced by that oxidative stress.
No, not unless you have a premium policy that covers experimental new drugs. Irminix® is not on the drug schedule of any insurance program as it has not yet been approved anywhere in the world to treat a specific disease.
Eventually, yes. In the near future we hope to have Irminix® approved in the US for pets who are heavy metal toxic from their diets. It has been available for some time in the EU under a different program for wild animals and animal rescue. Irminix® gavaged into heavily metal toxic and incapacitated eagles and eagle owls in Sweden recovered remarkably quickly and were later able to fly appearing to have totally regained their health. We will announce the availability of Irminix® for pets on our website and in our newsletter.
Yes and no. It depends on whether or not your particular condition is the subject to an ongoing study. On the other hand, in the US and Canada you can join an FDA or CDA approved ongoing IND study and receive the compound. You can be a study of one if you want to see if Irminix® is beneficial for your condition as long as your physician or dentist agrees.
IND is the abbreviation for Investigative New Drug, a term used by the FDA. This designates a drug that is under investigation that has not yet been given market authority but has likely been determined in a Phase I study to be reasonably safe. With an IND the developing drug company is allowed to provide the drug to those who may benefit and have an informed consent that is supervised by an Institutional Review Board. The results of taking the drug is then tracked by the company and this data can be reviewed by the regulatory authorities and used to supplement the clinical trial data for market authority. See further information under our Early Access programme.
Currently, this law is not applicable, but it may soon be. The legislation was designed to allow those with serious debilitating illnesses such as cancer or heavy metal poisoning access to drugs before the drug has completed all of the requirements for drug approval regarding being safe and effective. For it to apply, the drug needs to be in a clinical trial in the USA, which Irminix® currently is not.
Pure mercury is an uncharged, liquid heavy metal that vaporizes into a gas rather easily that has been known for centuries as a deadly poison, but it is still used in dental fillings, fluorescent lights, medical treatments and even in religious ceremonies in some countries. It is also found in substantial amounts as toxic methylmercury in most fish (both freshwater and ocean) especially large predators like swordfish, shark and tuna. In nature mercury is mostly stored in the mineral called Cinnabar or mercury sulfide abbreviated as HgS, which is misleading. Mercury sulfide is a polymer of (-S-Hg-S-Hg-S-)n where essentially every Hg is bound to two sulfurs. The mining of mercury involves the collection of Cinnabar and its exposure to high heat to release mercury vapor which is cooled to liquid form and used in industry. Inadvertently, some Cinnabar is in coal and burning such coal to generate electricity releases mercury vapor which ends up in our environment and in our diets.
Because Mercury (Hg) is an element that likes sulfur it is the bully that reeks havoc in biological systems in so many ways. Mercury displaces essential metals like iron and copper off of their natural binding proteins that require them for activity such as the energy producing electron transport system of the mitochondria and hemoglobin and other iron dependent enzymes or iron storage proteins such as. The body cannot tolerate hydroxy radical producing redox metals such as iron freely floating around destroying normal cellular functions. Excess free Iron displaced in normal mitochondria inside your cell converts them into free radical factories so instead of making energy they make radicals. We believe it was this action that mainly cause the mercury poisoned Ecuadorian gold miners to be so exhausted with chronic fatigue in the Phase 2 clinical trial.
In addition, mercury tightly binds to sulfur in proteins and this sulfur is extremely important to make selective membranes that protect your cells, arteries or brain. Mercury causes tight membranes to become leaky and unable to contain the compartmentalization of organs that are required for good health and this can lead to artery disease even headaches and food allergies associated with leaky gut syndrome. Mercury will also attack proteins such as enzymes that have sulfur to sulfur bonds causing it to unravel be misfolded i.e. change their shape leading to either enzymes that do not function or autoimmune disorders. Some have proposed that he immune system sees these partially misfolded protein and forms antibodies to them but since they are actually your own tissues your immune system mistakenly attacks you.
Many processes in brain need sulfur bonds. Once non-reactive and non-toxic Hg0 vapor is inhaled it can easily pass into the brain area through the blood brain barrier. Once inside it will likely encounter catalase, an abundant enzyme. Catalase strips off two electrons to form reactive and toxic Hg++. This aggressive heavy metal will knock out new nerve growth and even remove myelin from the axon sheath. It also causes the abnormal aggregation of microtubulin and the formation of neurofibillary tangles and other abnormal biochemistry associated with neurological diseases such as Alzheimer’s disease.
In summary non-reactive mercury vapor (Hgo) is capable of easily passing through all biomembranes and entering the cells of the central nervous system. There it is rapidly converted into the very toxic and reactive Hg2+ which inserts itself in many normal processes to break them and turns your own body and brain into a non-functional biochemical train wreck. How bad and how soon a wreck occurs depends on a number of other factors such as susceptibility, genetics, how much mercury you are/were exposed to (dose), your concurrent burden of other heavy metals and likely several other factors not yet discovered. The best policy is to avoid all exposure to mercury. Irminix® has been shown also pass through biomembranes and to bind Hg2+ rapidly (Clarke 2012) and may help those exposed to recover some function if given soon after exposure before the damage becomes permanent.
Irminix® is a very small trap for most heavy metals especially mercury. It’s structure consists of two natural substances. The body looks like a stop sign as it is made from a dicarboxybenzoate. This can be found in foods such as cranberries. The body has two arms spaced far apart made from a common amino acid found in most proteins called cysteamine. cysteamine is a two-carbon molecule that ends in a sulfur. Both the amine nitrogen and the carbons freely rotate allowing the molecule to change configuration with ease.
Think of the blow-up man in front of the oil change gas station with long floppy arms. When this molecule floats by a reactive mercury atom that has wedged itself into a membrane or protein it presents beautiful sulfur hands that open and available for the mercury to bind to. As a result, mercury will let go of the membrane sulfur and happily hook up with Irminix® which provides a second sulfur that forms the most stable (see Cinnabar structure above) -S-Hg-S structure of mercury binding. The two together form an inert particle that is gradually removed by the P-450 detox pathway for removal through the bowel, but in the mean time, due to its non-reactivity it causes no injury. Animals fed very large quantities of Irminix®-mercury complex (e.g. Hg=S) suffered no injury even though the two flowed into every tissue and then came out again. It was without measurable toxicity.
Why? Irminix® forms a two semi covalent bonds with Hg2+ and these are two very strong bonds that cannot be broken under normal physiological conditions as exist in the mammalian body. To break the bond you must heat it to 2370 C (458.60 F) to bust apart the body. The aggressive bullying of the heavy metal stops because it is totally happy bound up with Irminix®.
Interestingly Irminix® does not deplete your normal minerals as most other chelators have been shown to do. It also does not engage in any essential physiological process or enzymatic actions as it does not alter any normal functions. Because Irminix® is lipid (fat) soluble it can easily pass through the blood brain barrier, arteries and even through cell membranes. It goes everywhere and when it finds mercury it places one sulfur on each side to form a stable inert molecule as exists in the non-reactive mineral form stored in the environment.
That depends on whether the damage is permanent. In the clinical study of the mercury intoxicated gold miners the majority recovered from tremors. Damage to the nervous system by mercury is a serious injury. Now that we’ve had considerable experience with mercury intoxicated dentists and Irminix® we can say that some if not all the symptoms abate to a very large degree if caught early. This explains why the majority of investors in EmeraMed LLC are dentists and physicians who actively used this compound on themselves or their patients.
If you are a non-US citizen: yes.
If you are a US citizen: Possibly yes but only if you are what the Security and Exchange Commission (SEC) calls a sophisticated investor. EmeraMed LLC is not a publicly traded stock and as a result it is not on any stock exchange in the world. A Sophisticated Investor is a classification of investor indicating someone who has sufficient capital, experience and net worth to engage in more advanced types of investment opportunities. For those selling stocks in companies that are not publicly traded the SEC is concerned about scammers taking the unsophisticated investors money. To prevent that they limit how many and who can invest.