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Friday, 03/18/2016 12:39:40 AM

Friday, March 18, 2016 12:39:40 AM

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$PMCB Oncomed Pharmaceuticals Stumbles, But Pharmacyte Biotech Continues to Offer Hope in War on Pancreatic Cancer

Oncomed Pharmaceuticals Inc. (NASDAQ:OMED) just reiterated today how tough pancreatic cancer is to beat. Pharmacyte Biotech Inc. (OTCMKTS:PMCB) is also tough though, and continues to move forward with the cancer community's next big leap forward in the war on pancreatic cancer.


For fans and followers of Oncomed Pharmaceuticals Inc. (NASDAQ:OMED), the new trading week is getting started on the wrong foot. Although the company is going to continue on with this particular stage of the trial, the so-called ALPINE trial of it cancer immunology drug tarextumab as a therapy for pancreatic cancer doesn't look like it's going to meet its endpoint goal.

The announcement from OMED underscores just how tough pancreatic cancer is to beat; this is hardly the first instance of a well-known (and otherwise effective therapy) failing to do much good when it comes to treating the dreaded disease. Yet, the stumble for Oncomed Pharmaceuticals also puts a small biotech firm called Pharmacyte Biotech Inc. (OTCMKTS:PMCB), as it's developing a pancreatic cancer treatment option that just might be the next, long-awaited quantum leap for this particular sliver of the oncology world.

Just for the record, in the phase 2 ALPINE trial, Oncomed Pharmaceuticals observed a distinct lack of benefit -- no progress in terms of progression-free survival or overall survival rates -- compared to a placebo. Such results contrast with trials recently performed by Pharmacyte Biotech.

Pharmacyte Biotech is the developer of a biotechnology called Cell-in-a-Box(r). In simplest terms, Cell-in-a-Box(r) is a means of encapsulating live cells -- cells grown to perform a particular function -- and implanting these pinhead-sized capsules in the body to perform a specific medical purpose. The technology has many applications, but PharmaCyte Biotech is furthest along in its development of the idea as a means of treating pancreatic cancer.

In phase 2 trials, PharmaCyte has shown that catalyzing a prodrug form of cancer-fighting therapy ifosfamide in the bloodstream physically near the cancer-ridden pancreas maximizes the effectiveness while minimizing the dosage. Ergo, this approach has proven superior to activation of the drug in the liver.

While potent, ifosfamide can also cause significant side effects when taken at doses large enough to effectively fight cancer. That's because liver-activated ifosfamide must make it all the way through the entire circulatory system before it reaches the pancreas. Most of the drug never reaches the pancreatic tumor. By activating the drug in the leg, though, the activated ifosfamide only needs to travel a few inches to reach the pancreas. The end result is an impressive degree of efficacy at only one-third the normal intravenous dosage of ifosfamide.

In a phase 1/2 trial examining the benefit of the Cell-in-a-Box(r) activation 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.

The initial goal of Pharmacyte Biotech and its Cell-in-a-Box was as a frontline treatment, where it performed very well relative to current first-effort therapies of gemcitabine or a combination of gemcitabine and Abraxane. As the study progressed, however, the company recognized the drug ifosfamide when activated by its Cell-in-a-Box platform could effectively meet a much bigger and perhaps much more lucrative unmet need... pancreatic cancer patients for whom gemcitabine or the combination of gemcitabine and Abraxane was no longer effectively shrinking a tumor (even if it had stopped its growth).

That's about 40% of the pancreatic cancer patient population completely up for grabs, so to speak, as there is no "good" solution. Pharmacyte Biotech may be about to change that.

The next step is a redesigned phase 2 trial. The trials had to be reworked when the company recognized it would be better off aiming at a slightly different target. The new plans are taking shape right now, however, and the new phase 2 trial should begin soon. It's a reason to be excited about PMCB.

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