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Wednesday, 11/25/2015 12:22:28 AM

Wednesday, November 25, 2015 12:22:28 AM

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$PMCB Pharmacyte Biotech Will Make You Rethink What's Possible in Treating Diabetes

Novo Nordisk A/S (NYSE:NVO) , Eli Lilly and Co. (NYSE:LLY), and even MannKind Corporation (NASDAQ:MNKD) have all made their mark on diabetes, but Pharmacyte Biotech Inc. (OTCMKTS:PMCB) is the only one in a real position to change the diabetes treatment paradigm.

It's not often realized, but diabetes treatments haven't changed much since Eli Lilly and Co. (NYSE:LLY) first start to mass produce insulin in the mid 1920's. In the meantime, Novo Nordisk A/S (NYSE:NVO) has taken the lead as the biggest name in diabetes treatment, but the underlying science has never changed in nearly a century - the injection of insulin into the bloodstream using a needle. Yes, MannKind Corporation (NASDAQ:MNKD) potentially had a game-changer in Afrezza - an inhaled insulin - a couple of years ago, but the drug has been a huge disappointment on the sales front, abating the threat to industry leader Novo Nordisk in the meantime; Eli Lilly is still holding onto a decent piece of the old-school insulin market as well.

Investors who think there's no potential alternative diabetes treatment that could still pose a threat to Novo Nordisk or Eli Lilly (after the MannKind debacle), though, may want to take a look at an up-and-coming company called Pharmacyte Biotech Inc. (OTCMKTS:PMCB).

Diabetes, in simplest terms, is an excess of glucose (sugar) in the bloodstream. Normally the human body can process and remove this glucose with insulin produced naturally produced by the pancreas. For diabetics, however, the insulin-producing beta cells in the pancreas are destroyed by that body's immune system.

Several companies have toyed with the idea of depositing or replacing the islet cells in the pancreas as a therapy for type 1 diabetes, which would effectively serve as a cure for the disease. These ideas showed promise too, but were largely problematic. Either these cells were still ultimately attacked by the immune system, or the mechanical structure required to place them in the pancreas failed. To this day, the only viable treatment of type 1 diabetes is the original one... forcing insulin into the bloodstream from outside the body.

Pharmacyte Biotech, though, may be on the verge of a breakthrough that could rekindle the idea and effectively negate the need for external injections of insulin.

The technology is called Cell-in-a-Box. Pharmacyte Biotech developed it as a means of depositing living, normally-functioning cells into a particular part of the body where their presence would have a therapeutic effect. In this case, the cells "in the box" would be insulin-producing islet cells placed in the leg near the bloodstream. Just like a patient's own cells would detect the presence of glucose and begin producing insulin, the cells inside the encapsulation are capable of sensing high levels of glucose and produce an appropriate amount of insulin.

The key is the material used to encapsulate living cells.

The manufacturing process begins with the mix of live cells (insulin-producing Melligen cells, in this case) and a polymer which are sent through a droplet-forming machine and into a small vat of a proprietary polymer. When the two polymers join, a membrane is formed, with the living cells inside of it. This shell keeps the cells inside, yet lets insulin out, while allowing nutrients in, and waste out. Most important though, the shell keeps the body's own immune system from killing these cells.... something most previous encapsulation approaches didn't do. A handful of these pinhead-sized capsules containing Melligen cells can replace the insulin-producing function of the pancreas from some other site in the body.

Cell-in-a-Box as a treatment pathway for type 1 diabetes is currently in the preclinical testing phase, although it was recently determined to be safe as a means of treating type 1 diabetes by the University of Veterinary Medicine Vienna. Based on the results witnesses in the preliminary studies at the university, the company aims to move forward with plans that will ultimately result in human trials

It's a major leap forward for diabetics - an encapsulation biotechnology that actually works for the long haul.

There's still work to be done. Cell-in-a-Box as a treatment pathway for type 1 diabetes is currently in the preclinical testing phase, although it was recently determined to be safe as a means of treating type 1 diabetes by the University of Veterinary Medicine Vienna. Based on the results witnesses in the preliminary studies at the university, the company aims to move forward with plans that will ultimately result in human trials.

Prof. Ann Simpson of the University of Technology Sydney (UTS) in Australia will have a great deal to do with the next steps. She's one of the world's top authorities on Melligan cells... the kind of non-pancreatic cells that can be induced to become insulin-producing cells. She and the University of Technology Sydney recently came to an agreement with Pharmacyte to push forward with the R&D needed to turn the idea into an actual solution.

And yes, though still in preclinical testing, the premise has been proven safe.

The work will be worth the effort. The diabetes treatment market is worth an estimated $7 billion per year, and Cell-in-a-Box is effectively a cure for it that abates the need for needles. In the meantime, investors are apt to reward the stock as the company achieves critical milestones en route to the endzone.

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