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Monday, 07/06/2015 5:43:04 PM

Monday, July 06, 2015 5:43:04 PM

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$PMCB An Old Drug With a New Spin is Promising for Cancer Patients as Well as Investors (PMCB, CELG, LLY, RHHBY)

Ifosfamide, sometimes called by its brand-name version Ifex, is undoubtedly a great cancer-fighting drug. It's prescribed as a treatment for soft-tissue sarcomas, testicular cancer, cervix cancer, and bladder cance- just to name a few - because it's highly effective. You can add pancreatic cancer to that list of approved uses for ifosfamide.

That's not to say ifosfamide is ideal for pancreatic cancer patients, however.

Though potent, at doses big enough to make a difference for pancreatic cancer patients, it can also be debilitating. See, ifosfamide, or Ifex, also commonly causes side effects like blood in the urine, shortness of breath, unusual bleeding, stomach pain, dizziness, and more. In many cases, the side effects of the ifosfamide simply make it not worth its efficacy, pushing oncologists toward more viable even if less effective options like gemcitabine, made by Eli Lilly and Co. (NYSE:LLY), in conjunction with Tarceva, made by Roche Holding Ltd. (OTCMKTS:RHHBY). The other preferred treatment option for pancreatic cancer is gemcitabine used in conjunction with Abraxane, from Celgene Corporation (NASDAQ:CELG). The combination of Abraxane with gemcitabine is the "go to" option in most cases, as it's shown the best efficacy relative to its tolerability.

What if, however, an inspired biotech company could lower the dose of ifosfamide required to be effective? Pharmacyte Biotech Inc. (OTCMKTS:PMCB) is that inspired company.

The knee-jerk question is, how can Pharmacyte Biotech lower the dose of any drug and not alter its ability to fight cancer. The answer is, make the drug inside the body, very near the pancreas itself.

It's a largely unappreciated truth about modern medicine, but most of the drugs put in a human body never make it intact to their intended destination. Either the immune system or the body's normal functions break down drug molecules - some of them rather quickly - before they do any good. In most cases it doesn't matter because enough of a drug end up where it needs to be to be effective. If the side effects of a drug are serious, however, a necessarily big dose may end up doing more harm than good.

And yes, ifosfamide is one of those vexing drugs that oncologists would like to be able to use more often for pancreatic cancer patients, but simply can't. Pharmacyte Biotech may be on the verge of changing this reality.

The game-changer is a biotechnology called Cell-in-a-Box.

In simplest terms, Cell-in-a-Box is a means of placing hundreds of live cells inside a capsule about the size of the head of a pin. The cells inside the capsule produce a P450 enzyme, which activate an otherwise inactive form of ifosfamide to produce an anti-cancerous effect.

The upside to this approach is precision placement.

Ifosfamide in its active form is usually delivered intravenously. The process "works", but much of the drug doesn't make it to the pancreas. To deliver a dose big enough to make a dent in a pancreatic tumor, the aforementioned nasty side effects are often a given. The Cell-in-a-Box approach circumvents this inefficient form of delivery by inserting encapsulated P450-producing cells very near the tumor itself, which means ifosfamide isn't activated until it's at or near the pancreatic tumor, which means the bulk of the drug is delivered where it needs to be delivered. This, in turn, means less of the drug is necessary to produce a response. Less of a drug means fewer side effects.

More important, Pharmacyte Biotech has demonstrated measurable efficacy with this approach.

In a phase 1/2 trial examining the benefit of the Cell-in-a-Box delivery of ifosfamide versus the results gemcitabine would be able to achieve alone, the Pharmacyte approach improved the median survival timeframe from 28 to 44 weeks. Equally impressive is the fact that the number of one-year survivors increased from 18% to 36% of the study's patients.

There's still work to be done. The company reports it's aiming to begin phase 2b trials of ifosfamide activated by Cell-in-a-Box capsules in the third quarter of this year, which will compare it to the current preferred treatment... the combination of Abraxana and gemcitabine. The results achieved thus far, though, look promising.

As for investors, it's encouraging to see a new spin being put on an old medicine. Even more encouraging is that it's an idea that's paid off with fantastic results so far. And, that's more than exciting. At stake is a pancreatic cancer treatment market worth roughly $1.5 billion per year.
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