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PharmaCyte Biotech Awaits Pivotal U.S. Study Results Expected to Lead to Human Clinical Trials

PharmaCyte Biotech Awaits Pivotal U.S. Study Results Expected to Lead to Human Clinical Trials

Written by Ι Stock Market Media Group  — April 23, 2015

PharmaCyte Biotech (OTCQB: PMCB) is not a big company by any means, but their lineup of treatments is certainly standing tall these days. The international biotech firm is already set to head into Phase 2b clinical trials in advanced inoperable pancreatic cancer later this year in Australia. PharmaCyte even made headlines in the diabetes industry two weeks ago after a study was published that stated its Melligen cell line could produce insulin in diabetic mice.

This news essentially means the company is well on its way to reversing the diabetes condition if the cell line proves to be safe, and those cells can be encapsulated using PharmaCyte Biotech’s signature live-cell encapsulation technology, Cell in a Box®.

While this research could potentially serve as blockbuster news for the future of PharmaCyte Biotech’s diabetes treatment, it is another study that has the company’s investors a little preoccupied these days. Those who follow the Silver Spring, Maryland, biotech are waiting on pins and needles for what should be extremely promising data from a follow-up preclinical study being conducted in the U.S. to treat the onset of malignant ascites fluid.

The results of this highly anticipated study should lead the company right to the Food and Drug Administration’s (FDA) door requesting to begin a Phase 1 human clinical trial to treat a “quality of life” symptom that all abdominal cancer patients deal with regularly. The study is being performed at the prestigious Translational Drug Development (TD2) in Scottsdale, Arizona, under the watchful eye of renowned oncologist, Dr. Daniel Von Hoff.

In the initial preclinical study, TD2 used 4 groups of mice that were implanted with human ovarian cancer cells in the peritoneal cavity to determine if PharmaCyte Biotech’s pancreatic cancer treatment, which combines Cell in a Box with the anticancer drug ifosfamide, could, in fact, have an effect on slowing the accumulation of the dangerous fluid.

At the end of that study, PharmaCyte announced that the mice receiving the company’s treatment “produced a significant survival advantage over those non-treated mice.” Another finding in the study was that the data from the mice treated with the company’s technology proved that Cell in a Box plus ifosfamide performed as well as cisplatin, which is the current standard of care for ovarian cancer.

But interestingly, what has many investors on the edge of their seats waiting to see the latest results is that when the encapsulated cells plus ifosfamide were used in conjunction with cisplatin in the initial study, the survival rate was “greatly enhanced.” While this was an unexpected result from the study, it could potentially be great news for investors and for those patients who live with one of the many abdominal cancers like pancreatic cancer.

In the follow-up preclinical study, the company added many more groups of mice to gather as much data as possible to present the best possible scenario in slowing the onset of the malignant fluid. This time TD2 is studying 12 groups of mice with 10 mice in each group. Because this is a treatment that can potentially improve the “quality of life” in cancer patients, it is anticipated that results equal to or better than the first preclinical study will back up the earlier data and just might mean that PharmaCyte has a great opportunity to set its attention on becoming the standard of care for malignant ascites.

As investors eagerly wait for those results from PharmaCyte, it is the company that could be eagerly waiting on the data as well to find out what new bit of data they could uncover with the additional groups of mice. One thing is for sure these 120 mice have a fan club hoping the data they produce is enough to deliver right to the FDA.