Monthly Archives: May 2013

A Method To Distract Bone Slowly Using Magnetic Fields, Metal Implants, And Acidic Solution

While we have all been thinking about mechanical ways on how to possibly pull bones apart to lengthen them, I came to realize that there may be a simpler way to lengthen bones, using certain basic physics principles that we have not thought about.

What I am going to propose is that maybe it is possible to use magnetic fields to create forces which can cause the bone sections to pull apart from each other.

I am reminded of the idea of applying a capacitative electrical field through two metal electrodes attached to lateral sides of the growth plate region in teens and children with open growth plates to accelerate longitudinal growth. It was proposed by Dr. Carl Brighton in the landmark patent and study below…

Other studies were written by researchers who were doing very similar research

I still need to refer to the paper “Electrical Stimulation in Tissue Regeneration” to fully understand just how human tissue and cells would react from applied electrical signals.

The point is to show that beyond using a contant capacitive electric field to stimulate growth plates to increase the growth process faster, it might be possible to use the other half of the Electromagnetic Field & Waves phenomena for height increase purposes.

If we remember from elementary school science, there is the North and South Poles of any magnet and they attract each other. If we had two North or two South Poles, they would repel each other.

I am proposing that it might be possible to create two poles that are the same on opposite sides and induce them to pull away from each other and having the metallic rods or rings held to the human bone.

With a AC electrical signal, we can induce a magnetic field that increases in strength and then decreases like a intermittent way to push at the bones.

Let’s look over some introductory university level electromagnetic theory. There is no mathematics, just some conceptual electromagnetic reasoning.

First, I have clipped the chart for the Differential and Integral form of Maxwell’s Equations from the Wikipedia article on Maxwell’s Equations

Maxwell's Equations

Side Note: If any person can manage to prove the existence of magnetic monopoles, they would validate many of the ideas of string theory and definitely receive a Nobel Prize in Physics for this achievement. I have taken an advanced level undergraduate electrodynamics course using the standard Introduction to Electrodynamics, 3rd Ed. by Griffiths so I should still remember a little bit of the course still.

In general, when one sees the symbol for an integral, where it is a double integral, triple integral, closed path integral, line integral, surface integral, the basic idea is that you are to sum everything that is specified together. The term integration basically means to add all of the possible alternative ways together.

This is my personal level of conceptual understanding of the 4 main laws.

Guass’s Law – When you add together all of the Electrical Fields, E over a closed surface, you would get a charge density divided by a universal constant. For practical purposes just forget the constant and realize that the whole point is to calculate a quantity of charge and Electrical Field in a 3-D space.

Guass’s Law of Magnetism – The Integral form suggest that if you add together all of the Magnetic Field, B in a closed surface, the net result is 0. The reason that the net magnetic field is 0 is because of that fact that magnetic fields are derived from a dipole system. Everything that has a origin will also end up back in the same origin at the end of the path.

Closed Surface – The concept of a closed surface is important. The idea is to create an imaginary boundary condition, like a infinitely thin spherical shell which will encapsulate the system one would try to calculate the net charge is in the region that is defined by the boundary conditions.

Faraday’s Law Of Induction – This is the first of the two other laws of the four which is slightly more complicated so I wanted to break the conceptual understanding down into looking at both the Integral Form and  the Differential Form

  • Integral Form – When you add together all of the Electrical Fields, E in a closed path, using a line integration you would find it equal to the change in time of the sum of the Magnetic Fields, B added together in a specific surface that is also going in the opposite direction
  • Differential Form – We can create an electrical field by changing the magnetic field

Ampere’s Circuital Law w/ Maxwell’s Correction

  • Integral Form – The combined total of all the Magnetic Field in a closed path loop is equal to the change in the combined Electrical Field added with a hidden electric field over a surface, both multipled by a certain special constant which is over a given specific surface
  • Differential Form – An Electric Field and a change in Electric Field will both lead to the creation of a magnetic field

Implications For Height Increase Applications

If we look at the last two equations of Maxwell’s E&M , and remember back to the way that induced magnetic fields from electrical work and which direction they go in, it seems reasonable to think that we can induce a magnetic force that would push two electrical hard wires farther apart from each other. If the wires are also somehow held in place against bone tissue, then they can theoretically over time using magnetic force pull bone tissue apart.

Electric MotorLet’s look back at how the common electric motor works, even those that one finds in plastic toy cars.

The power source is a battery, which is DC electrical source. The electrons inside the copper wires go down the wires which is connected to the battery which is how current is created. The electrons that create current will create charges, which results in a electrical field. From Faraday’s Law of Induction, the wire does form a closed path since the wire is connected in a way for a closed circuit to the battery. This causes both a magnetic force and a change in magnetic force. Since there is already magnetics put in the system, when there is a magnetic field, S or N, the force between the created magnetic force which is changing and the magnetics already in place will cause the magnetics to either attract or repel each other.

To create the alternation that is needed to change, what are known as brushes to close and open the wires forming either closed or open paths are needed in the system.

magnets__levitatingThe point is that it is reasonable to create a two non-magnetic metal ring system which will have electrical current run through them, which will induce the metal into a magnet, and they will develop the repulsive force and pull themselves away from each other.

At this point, the theory makes sense but I am not sure how to design the actual device. It is totally possible that this proposed idea is not viable since people may reject the idea of having metal rings embedded deep onto the surface of the bones.

Just refer to the picture on the right for reference. Of course it would be difficult to embed the metal in the first place into the bone if they are already magnets. The other problem is that the magnetic force of the small magnet to the right are too weak so that is why we need to have ferromagnetic metals which when they have a current passed through them, they turn magnetic. Not only that, the more current that can be passed through, the stronger the magnetic field can become and the harder the metals will try to pull apart from each other, thus distracting the bones that they are embedded or attached to.

There is also a second part. It is critical if we think that an induce magnetic field from a battery current would even work.

It is to make the area of bone that we are trying to distract weaker. Like I said multiple times before, the bones are just too hard and strong and brittle to pull apart using normal devices. I calculated in the post The Values For The Magnitudes For The Forces And Loads Needed To Increase Epiphyseal Cartilages Thickness And Human Femur Bone Without Fracture (Important)that it would require about 25,000 – 30,000 lb of tensile loading force to pull the adult human femur apart elongating it, if not outright snapping it in half the moment the critical threshold, which is known as the Ultimate Yielding Strength is reached. Certain studies like DIFFERENCES IN THE TENSILE STRENGTH OF BONE OF DIFFERENT HISTOLOGICAL TYPES“ agree that the calculated value is about right.

This means that the bones need to get weaker, at least in terms of getting the calcium hydroapatites removed, which has alway been the primary element that gives bones their hard, brittle nature. In a recent post I discovered that one can actually turn bone tissue into rubber using vinegar which is just ascetic acid.

So there is two parts to a device, one where two rings are embedded on the bones of the individual which can’t be moved and an induced current will cause the magnets to start to push themselves away.

In the middle, between the two rings, a solution of ascetic acid or vinegar is injected using small plastic needle syringes into the cortical bone layer to start to remove the calcium crystals.

The bones in just one band or layer grow weaker as the collagen is left and the bone is distracted.

Can Twisting The Torso While Stretching Loosen The Vertebrate For Temporary Height Increase?

Something I had mentioned before in the post “Increase Height And Grow Taller By Stretching” was that there was probably only 4 main exercises which are stretches that can help one potentially increase their height, at least temporarily.

One of them was the forward stretch, the second was the Cobra Position in basic Hatha Yoga, the third was where one was sitting in with the legs wrapped in the lotus position with the arms being brought above the head to the other side stretching vertically one’s lats and side stomach muscles. The last was the idea of twisting the torso from side to side.

Torso-Twist-StretchI wondered whether the last method might be more effective than the other types of stretching since it is only type of stretching that can lossen the vertebrate and disks between the bones slightly more than the others. It is also an uncommon position for the body to be in.

I would guess that since this type of stretch is not a natural type of movement that the human body was ever needed to be in, it would be more likely to result in a disruption in the way that the human body would normally deform. This means that maybe the way that the bones are held up would change slightly, pulling at the ligaments and cartilage that hold the individual bones together to become more elastic and looser for a greater range of movement and mobility.

desk_stretchesLike I showed in the recent post on the analysis of Ehlers Danlos Syndrome “A Study On The Possibility That Ehlers-Danlos Syndrome Might Lead To Adult Height Growth“, it is possible that increased joint mobility may result in a slight increase in height since the bones don’t have to be in their fixed locations all the time. When a person is using their muscles to stretch out their entire body body by extending their arms and shoulders as high as possible, maybe the upper torso can be pushed up just slightly.

The other 3 types of stretching that I referred to in the stretching post, humans have had to do for a long time.

The forward stretch has been done by most people who were standing up and needed to pick up something on the ground without bending their knees. Even little kids in elementary school would have done this exercise.

The cobra position is probably the other position that has the most effectiveness in increasing body flexibility and realigning the spinal curvature. Most kids would also do a lot of this when they are playing to push themselves off of the ground.

stretchingThe laste position where the arms are being extended over their head to the other side is something that primitive ancestors probably did to try to reach for fruits in tall trees. I doubt that this stretching would be the best type of stretching to increase height, but it might help a little.

Grow Taller By Improving Our Posture By Lifting the Shoulders, Breathing In The Stomach, And Pushing Up The Chest

I am not sure if this idea is even valid due to the curvature of each individual person head relative to the vertebrate. However maybe the easiest way to increase one’s height is to develop a more confident, upwards posture.

puffed chestThe three parts towards displaying confidence through body language in males is to…

  1. Breath in the stomach
  2. Pushing upwards the chest
  3. Lifting the Shoulders

It is basically the idea that having one’s chest pushed outwards means that the vertebrate will be more likely to be straighter.

What I am describing is what most people do when they are getting their height measured, which is to try to maximize the height measured.

Most people who stand have some curvature in all of the sections of the vertebrate, from the cervical to the thoracic to the lumbar area.

In general there is little that simple posture and stretching can change the lumber are of the back. Only rolfing or a chiropractor can have a chance of causing the vertebrate to be aligned striaghter.

structbodyThe thoracic section is usually curved and that is also not easy to straighten out. The cervical region is the area which is the most flexible.

The human body is designed so that most people can only bend in the forward direction. Contortionist are the exception. What we want to focus on is to decrease the natural curvature of the vertebrate to something that is straighter. If the series of vertebrate bones are kept taut and aligned properly, there will be less height lost from curvature.

So there is basically one concept in this idea on possibly increasing ones height. It is to use the muscles in the torso to expand out to pull the upper body area up against the gravity, thus resulting in a slightly increased measured height. However I have wondered whether lifting the shoulders up, breathing in the stomach, and pushing out the chest would mean that the overall torso would move upwards or it just seems that way.

Something else to note

Most people are actually really bad at estimating height, except for people who are 2 inches taller or shorter than them. (Whatever most men may think of themselves at being better than average height guessers, most are very wrong)

What most people do to compare their height with someone else is to look to where where they eye level is compared to the other person. For most people, as long as the eye level height of themselves is higher than the other person, they automatically assume that they are taller. What is not known to most people is that the distance from the middle of their eye level to the top tip of their head is around 4-5 inches long.

This might explain why more dominant , alpha males always tilt their head up and look straight forward instead of  lowering their head and look down on the ground.

The main point is that maybe from good strong, dominant body language where the shoulder, stomach, and chest are held in position that makes one look more dominant, it would appear to other people that one is taller.

If it actually works in using the body’s core abdominal muscles to temporarily hold up the upper torso higher to elevate one’s height is not known.

The Connection Between Using Heel Implants To Look Taller And Other Height Increase Methods

When the site first began I did a somewhat detailed and extensive post entitled “Grow Taller By Feet And Heel Implantations, Macrolane And Bio-Alcamid” on the ideas of implanting some type of foreign collagenous, elastic material into the heel to make a person taller.

Recently someone emailed me to take a closer look at the science and I felt that it was appropriate now to look back at this idea in a more scientific and analytical manner than when the site was only 1 month old when I much less information and knowledge on how growth in the human body works.

This idea on implanting a type of silicone into feet to gain upwards of only 1 inch was also mentioned in a thread entitled “Silicone implants in feets (LL 2-4cm)” on the Make Me Taller Forum

Analysis #1:

The actual article that is referenced in the thread is entitled “The latest in cosmetic surgery is hyaluronic acid“. The section that is taken and put on the Make Me Taller forum is actually sort of revealing. There is two options, go with the Microlane one or the Bio-Alcamid one. The Bio-Alcamid one is supposed to be permanent. The maximum height achievable with oen surgery is supposed to be 2 cms. For getting the temporary type of injection using the Microlane, one would pay around $1500 while the Bio-Alcamid would coast slightly more. If one wanted to increase their height more than 2 cms, they need to come back for subsequent surgeries.

The actual surgery seems to be extremely simple. There is the anesthetic injection in the beginning. Then the prosthesis is injected into the feet heel.  The prosthesis is not actually a physical device, but a polymer. The polymer seems to be a rubber like liquid form, which is injected into a needle into the heel of the foot. It takes only 30 minutes

As for the actual article reference , the stuff on hyaluronic acid, the idea is reasonable but would not work. Hyaluronic acid is one of the major components of the proteoglycans and glycoaminoglycans in the cartilage matrix and act as the lubricant in joint cavities. Along with aggrecan, hyaluronic acid is the most common element in synovial joints like the knee.

Hyaluronic Acid does have some good application in medicine and cosmetics (source). It has been used to remove wrinkles temporarily, decrease neck lines, make face look fuller, improve acnes scars.

The compound is very safe and is organic, and is made by the human body. It is shown to also stimulate collagen production a little. I even wrote a few posts about the possibility of using hyaluronic acid to gain a little bit of height in the posts…

  1.  “Increase Height And Grow Taller Using Hyaluronic Acid” 
  2.  “New Proposed Method To Increase Height And Grow Taller Using TGF-Beta1, Hyaluronic Acid, And Autologous Synovial Fluid” 

I would even list Hyaluronic Acid as one of the only compounds, besides Glucosamine Sulfate which has a chance to help adult humans increase their height, if just a little in the Supplements Guide section. The way that hyaluronic acid lubricates joints means that there is a chance that joint cavities will expand slightly from increased Hyaluronan consumption.

Interpretation

I would guess that most people who wish to gain some extra height would wish it to be permanent, not temporary. If the surgery was to just make a person 2 cms taller temporarily, it might just be smarter if the person wore lifts and elevator shoes, or get those height increasing socks with the thick insoles in them. The cost is around $1500 for the MicroLane is not permanent but lasts just 12-18 months. It is composed of hyaluronic acid which is hardened to be more polymer-like.

I would rather do more research on the permanent option, which seems to only cost a little more ($300). Let’s see what the Bio-Alcamid can do.

Analysis #2

From an article on website called DailyXtra.com entitled “The Bio-Alcamid Disaster” it is revealed that this compound was manufactured by a company based in Italy but it resulted in some severe facial deformities as side effects and complications.

Bio-Alcamid seems to have been used in the past in helping improve the facial appearance of people who had HIV and suffered through lipoatrophy, which is when the collagen and fat in the face becomes removed due to the antiretroviral drug cocktail solution taken to treat HIV (developed in the 90s)

Apparently the Bio-Alcamid was supposed to be designed with some type of protective layering around itself but there was none. From one source, it states about the protective layer…

“Once implanted, Bio-Alcamid, unlike many other injectable fillers, becomes covered by a very thin collagen capsule (0.02 mm) which completely surrounds the gel, isolating it from the host tissues and making it a real endogenous prosthesis…”

The primary active ingredient is called polyalkylimide which is a type of polymer. From the study “Cheek augmentation with Bio-Alcamid in facial lipoatrophy in HIV seropositive patients.”

“Bio-Alcamid, which is an injectable, biocompatible, nontoxic, nonallergenic soft tissue filler designed to correct tissue deficits of various volume by intratissue administration…”

The composition of the BIo-Alcamid are “… a gel polymer comprising exclusively of networks of alkyl-imide groups (approximately 4%) and nonpyrogenic water (approximately 96%). Alkyl-imide belongs to the family of acryl-derivatives and its polymeric structure does not contain free monomers.”

Interpretation

The idea of injecting polymers into heels to gain around 1-2 extra inches is not reasonable. The people who tried the Bio-Alcamid polymer on their face was trying to make themselves better looking after loosing so much collagen and fat. The Bio-Alcamid would over time settle in a way that distorted the face to look ugly. If the same Bio-Alcamid was injected into the feet, over time the polymer would start to loss it’s strength and start to distribute on the heel in uneven ways, making the heel also deformed. If the face which has no loading applied to it causes the Bio-Alcamid to start having problems, there is no way that Bio-Alcamid would ever be able to keep its structure and integrity (in a strength of materials sense) permanently. It would break down eventually, go into the body stream, and converted in the same way that adipose tissue and collagen are in the body.

So the idea of injecting any type of polymer as heel implants won’t work. The implant at the bottom of the bottom would get so much loading from the daily wear and tear of walking that it would eventually break apart, turning it into a jelly-like substance that gets absorbed into the body.

A Deeper Analysis On Indeterminate Growth For Height Increase Application

Many months ago I wrote only a short post looking at the phenomena of indeterminate growth and wondered whether it was possible to trigger that type of evolutionary or ecological step in humans entitled “Indeterminate Growth And Mammals“. Humans, like most mammals, experience determinate growth, which means that at some point, their growth will be stopped due to bone constraints. The bone constraint is when the bones don’t get any longer because the force to expand the bone volumetrically in any direction is too large for anything reasonable to do.

The reason why indeterminate growth is possible in some creatures is that the tissue that is holding the overall body form in place is cartilage, not bone. Bones are strong, light, and porous but they are too strong as well as being too brittle to be plastically deformed. Even if the necessarily high force was applied in a tensile way, the bones would rather fracture and break in half than to stretch out.

The types of animals which most people know do experience indeterminate growth lare fish and reptiles. The sharks, the largest types of fish in the world actually don’t have bones but cartilage which create the overall body shape. The backbone or vertebrate structure of sharks are cartilage, not bone tissue. This means that with enough nutrients being difussed through the cartilage backbone of a shark, the cartilage can theoretically get larger in size, making each of the cartilage vertebrate bigger, pushing the fish longer and longer. For fish, height for them is length. The bigger the cartilage get, the longer the fish become.

The size of how big fish can get can be huge. A good example is how big some catfish becomes. It may be hard to find catfish these days over 50 lbs and 3 feet long but there were stories of catfish growing to over 12 feet long when the European settlers first came to the Americas. Certain fish can live very long, and they never stop growing. The only way that fish size is usually limited is because the bigger fish are either caught by humans or eaten by something slightly bigger than them. This shows that as long as a fish is not eaten by a bigger animal or caught by humans, certain fish species will grow longer and longer until they become monsters. I am not sure whether some aquatic animals ever grow so big that they have no natural predators and actually die from natural causes like disease and infections. I guess the idea of the squid which grows into the giant squid might answer the issue with an affirmation.

The issue for humans to develop anything like indeterminate growth is to turn their bones into cartilage which can continuously get nutrients through diffusion through cartilage matrix collagen, produce chondrocytes from a mesenchyme location, and never experience growth plates closure.

Of course the likely result is that the cartilage is not strong enough to support the adult weight of the human individual. the cartilage tissue collapses in thickness, and the result is the vascularization of the cartilage area leading to calcification and bone tissue.

The reason why fish can experience indeterminant growth and have cartilage as the main supporting tissue is because they are living in the water, which has a bouyancy force that is pushed upwards. The effect of earth’s gravitational force is actually decrease substantially, if not completely negated. (forgive me if my conceptual physics understanding is completely wrong here)

If we do a fluid statics problem to see how the hydrostatic forces act in water in terms of point to point, we know that from the top of the Earth’s atmosphere to the ground sea level, the average atmospheric pressure is 1 atm or 760 mm Hg (Hg is the shorthand for mercury).

Usually Patm= 1 atm = 101325 Pa

To find the downward pressure at any level of water (or fluid) below the surface of the water, which is assumed at ground level, we use the formula…

Patm + rho*g*h = P

rho is density and the density of water is around 1000 kg/m^3. g is the gravitational constant which is about 9.81 m/s^2. So the pressure exerted on a fish or aquatic creature in the back (assuming that they are swimming in a horizontal direction with a dorsal and ventral side) is determined by the depth at which they live. However, from basic hydrostatic pressure principles, they also have a force that is pushing upwards on their body. This means that instead of in terms of the vertical growth that humans are thinking of, pushing upwards against the gravitational downward force of gravity, aquatic animals focus on growing longer, increasing in the horizontal direction. Since there is no forces that is pushing in the lateral direction, except for the hydrostatic pressures, the fish don’t have a force that is holding them back from growing longer.

They can have cartilage tissue instead of bones because the environment they live in does not have the forces pushing in the direction which would inhibit their growth, which is to grow longer horizontally.

Recently I wrote a post entitled “Growth Plates In Elephants Never Close Or Close Extremely Late Suggesting They Experience Indeterminate Growth (Important)” showing that the largest animals on land, the elephant might actually live to be around 150 years old and some elephant species might have cartilage belts in their legs meaning that they never stop growing throughout life. Even for elephants who are in their 5th to 6th decade, there is still cartilage found in their long bones indicating that they are still growing.

Something that was interesting is that even if the cartilage in the elephant’s legs have ossified, their vertebrate bones still have growth plate cartilage, so they might not be growing vertically longer but they are growing horizontally longer as their vertebrate bones get wider and bigger.

Implications For Height Increase

Humans are a land living, air breathing mammal species. For almost all of us, the cartilage which we were born with which allows us to grow taller eventually disappears. For some creatures, their body is held up in their respective structure by a type of tissue that is not as hard and brittle and strong as the bone.

Sharks and most fish have cartilage and that is okay since they live in the water, which forces them to focus on growing longer. Reptiles like snakes also have vertebrate which are very flexible. Snakes also supposedly never stop growing. However these types of species are all focused on growing longer, not taller.

To grow taller, we have to like the elephant. The elephant supposed have growth plates in their legs for a very long time. They also seem to keep growing horizontally due to unfused vertebrate almost to old age, at least from mammoth and asian elephant studies.

I am not sure which mechanism allows elephants to keep their growth plate for so long, especially since they are so much heavier than humans and there might be more weight or load per square inche of cartilage and chondrocytes than the average human body.

It is suggested that we study the signalling pathway of the growth plate process in elephants and compare them to human vertical growth to see what they are doing right in being able to keep their growth plates around for multiple decades beyond what the human species can do.

 

 

 

 

 

 

New Experimental Biological Enzyme Drug Asfotase Alfa Given to Janelly Martinez-Amador To Grow Bone

Recently I found a very interesting story about a young girl named Janelly Martinez Amador who is suffering from a rare bone condition known as Hypophosphatasia. She has the most severe form of hypophosphatasia, a genetic disorder that prevents skeletal mineralization that occurs in only one of every 100,000 infants. This means that the girl had no bones since to form bones, one needs mto have the progenitor cartilage cells to start calcification and mineralization. The girl didn’t have the ribs to support breathing and this was the thing that was going to be the main concern towards her life.

From USA Today: “New drug gives growth to girl born with no bones”

She was saved by this new experimental drug called Asfotase. From the same article…

“…Dr. Michael P. Whyte, a metabolic bone disease specialist with Washington University School of Medicine in St. Louis, about Janelly.

Whyte was about to start a clinical trial for a new drug, a biologic enzyme called asfotase alfa, that he wanted to try on toddlers with hypophosphatasia…”

“In February 2009, Janelly began treatment with a medicine that had been developed by Canada-based Enobia Pharma Corp. and put on fast-track approval status by the U.S. Food and Drug Administration because it was an “orphan drug” — the first possible treatment for a disease. Shriners Hospitals for Children and Enobia, which has since been acquired by Connecticut-based Alexion, funded the clinical trial.

Janelly had a special port surgically inserted in her abdomen so she could receive infusions of this bone-targeting enzyme.”

So this drug that is supposed to be able to mineralized non-mineralized bone is created by the Canada based company Enobia Pharma Corp.

Since we are height increase researchers, we will not focus too much on the particular case of Janelly but on the drug. Can the drug also cause an increase in the rate of bone endochondral ossification, resulting in increased longitudinal growth in developing children?

When X-rays were done on Janelly, there were no bones that were being shown, meaning that the bones were not absorbing the calcium minerals they are supposed to. It took over a year of this asfotase administering before the young infant was able to move her limbs, indicating that she had developed bones strong enough to lift the load of muscle and skin tissue in her body. When we look back at Janelly, it seems that she was still getting the injections of asfotase three times a week.

From the company that sells/created the Asfotase Enzyme, Alexion Pharmaceuticals

(Formerly ENB-0040)

Asfotase alfa is a highly innovative human recombinant protein being developed by Alexion for the treatment of patients with HPP. HPP is an inborn error of metabolism arising from a genetic deficiency.1 Patients with HPP cannot produce a form of the enzyme alkaline phosphatase known as tissue non-specific alkaline phosphatase (TNSALP), which is essential for regulating the phosphate levels in various metabolites that are critical for normal bone formation, and also for brain and muscle function.2 The asfotase alfa drug candidate is a recombinant protein designed to address this genetic deficiency by targeting another form of alkaline phosphatase, known as functional alkaline phosphatase, directly to the affected patient tissues. In this way, asfotase alfa is designed to counter the genetically defective metabolic process and prevent or reverse the severe and life-threatening consequences of dysregulated calcium and phosphate metabolism in patients with HPP.

Data from two Phase 2 studies, one in infants and young children up to age 3 with severe HPP, and one in juveniles ages 5-12 with severe HPP, show marked improvement in bone development, muscle strength, and respiratory function with asfotase alfa treatment. In both studies, every patient showed an objective response to asfotase alfa treatment with an improvement in mineral metabolism.1,3

Asfotase alfa was awarded orphan drug designation in the United States and European Union in 2008 and Fast Track status in the U.S. in 2009. If approved, asfotase alfa will be the first and only therapy to specifically address the underlying pathology of HPP through a targeted enzyme replacement therapy.

  1. MP Whyte, et al. Hypophosphatasia in Children: Enzyme Replacement Therapy Using Bone-Targeted, Tissue-Nonspecific Alkaline Phosphatase. 2010 ASHG, Abst. 3070.
  2. Mornet E. Review of Hypophosphatasia. Orphanet Journal of Rare Diseases. 2007:2:40 doi:10.1186/1750-1172-2-40. Available at:http://www.OJRD.com/content/2/1/40
  3. CR Greenberg, et al. Life-Threatening Hypophosphatasia in Infants and Young Children: Results of Long-Term Treatment with ENB-0040, a Bone-Targeted, Enzyme Replacement-Therapy (ERT), and An Algorithm For Patient Management. 2010 ASHG, Abst. 13.

Form the website AlexionPharma.com

FDA Grants Breakthrough Therapy Designation to Asfotase Alfa for Perinatal-, Infantile- and Juvenile-Onset Hypophosphatasia (HPP)

Tuesday, May 28, 2013 7:00 am EDT

LAUSANNE, Switzerland–(BUSINESS WIRE)–Alexion Pharma International Sàrl, a subsidiary of Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to asfotase alfa for the treatment of patients with hypophosphatasia (HPP) whose first signs or symptoms occurred prior to 18 years of age, including perinatal-, infantile-, and juvenile-onset forms of the disease. HPP is an inherited, life-threatening, ultra-rare metabolic disorder that leads to progressive damage to multiple vital organs, including destruction and deformity of bones.

The FDA also confirmed that adult-onset HPP is “a serious and life threatening disease or condition” and that Breakthrough Therapy designation could be obtained for this aspect of the disease with additional clinical information.

According to the FDA, a Breakthrough Therapy designation is designed to expedite the development of a drug to treat a serious or life-threatening disease when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. The Breakthrough Therapy designation is part of the FDA Safety and Innovation Act (FDASIA) of 2012.1

“The FDA’s Breakthrough Therapy designation for perinatal-, infantile- and juvenile-onset HPP recognizes the severe, debilitating and life-threatening nature of the disease, the clear unmet medical need of patients, and the clinical evidence collected to date on asfotase alfa,” said Martin Mackay, Ph.D., Executive Vice President, Global Head of R&D at Alexion. “Asfotase alfa is a highly innovative therapeutic candidate with the potential to transform the lives of patients with HPP who currently have no treatment options and often receive only palliative care for this life-threatening disease.”

About Asfotase Alfa

Asfotase alfa is an investigational, highly innovative, first-in-class targeted enzyme replacement therapy. Asfotase alfa is designed to address the underlying cause of HPP by normalizing the genetically defective metabolic process, and preventing or reversing the severe and life-threatening complications of life-long dysregulated mineral metabolism.

Analysis:

It is said that this new drug asfotase alfa is a type of recombinant protein that manages to stimulate the production of functional alkaline phosphatase aka tissue non-specific alkaline phosphatase (TNSALP), which is essential for regulating the phosphate levels in various metabolites that are critical for normal bone formation

The drugs is supposed to…

“…asfotase alfa is designed to counter the genetically defective metabolic process and prevent or reverse the severe and life-threatening consequences of dysregulated calcium and phosphate metabolism in patients…”

So what does this all mean to the average person? Human bone gets its hardness and strength from a compound known as hydroxyapatite which is a chemical compound made from calcium, a phosphate group, and a hydroxide group, (which probably is taken from a water molecule or hydronium ion). This shows the importance of having both calcium and phophates in the human bone matrix to make it hard. Janelly didn’t have the phosphate groups to work correctly to bind to the calcium and develop the hard crystals that would go into the bone extracellular matrix.

Somehow the asfotase alfa has the ability to get the phosphates and calcium element to work together to mineralize the bones like they are supposed to.