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PharmaCyte Biotech Moves Closer to Revealing Plan to Address Unmet Medical Need in Phase 2b Clinical Trial


September 30, 2015 - Bonita, CA

BONITA, CA--(Marketwired - September 30, 2015) - Cancer is the world's second most common cause of death, not too far behind heart disease. And, although no form of cancer is "good," pancreatic cancer is perhaps the least treatable and most discouraging, taking the lives of more than 86% of its victims within five years of being diagnosed. PharmaCyte Biotech Inc. (OTCQB: PMCB) is developing a treatment regimen that could significantly address this unmet medical need.

Despite years of study and research, the medical community has yet to come up with anything close to a treatment for pancreatic cancer that could be considered a real success. It's not just a lack of understanding about what the disease is and how it works limiting its treatment. Indeed, researchers now have a reasonably good grip on its intricacies. It's a considerably unmet need also because it's not an especially big market. Moreover, little has been done to specifically address pancreatic cancer, as most oncologists know even the best treatment options available still don't do a great deal to save or even prolong lives.

Dr. Matthias Löhr of the Karolinska Institute in Stockholm, Sweden, recently laid out the alarming statistics, explaining that pancreatic tumors can only be surgically removed in about 20% of pancreatic cancer cases; the other 80% of patients must turn to chemotherapy, radiation, and/or palliative care. That 80% of patients only survive, on average, between six months and a year after the diagnosis is made and treatments have begun.

It's within that sliver of pancreatic cancer patients -- where the need is the biggest -- Dr. Löhr believes PharmaCyte Biotech can make a big dent.

The technology is called Cell-in-a-Box®. In simplest terms, PharmaCyte Biotech has developed Cell-in-a-Box® as a means of encapsulating and implanting living cells into a patient's body where they can drive a specific therapeutic effect. In the case of PharmaCyte's pancreatic cancer therapy, these encapsulations (about the size of the head of a pin) contain about 10,000 live cells each that produce an enzyme that activates the cancer-fighting drug ifosfamide.

The advantage to such an approach is pinpoint placement within the human anatomy. The Cell-in-a-Box® encapsulations -- about 300 of them -- are placed as closely to the pancreatic tumor as possible. This is done by threading a catheter up through an artery in the leg leading to the pancreas. When the catheter is in place, the capsules are injected through the catheter and placed at or near the tumor in the pancreas. After they are placed, then low-doses of ifosfamide are given to the patient intravenously. This method of delivery allows for maximum drug efficacy with only one-third the normal dosage of ifosfamide, and there is little to no drug "loss" in the wrong parts of the body.

And make no mistake -- the need for such a solution is tremendous.

As Dr. Löhr pointed out, of the 80% of pancreatic cancer patients who don't have the option of surgical removal, about half of them are proverbially trapped in the middle because their tumor is neither growing nor shrinking and surgery isn't possible. They'll simply be forced to live with a pancreatic tumor, hoping it doesn't metastasize, remaining on a drug regimen with just so-so effectiveness controlling the disease. Sooner or later, though, it does metastasize. Beating it is always the better option, if possible.

It's this sizeable segment of the pancreatic cancer patient pool where PharmaCyte Biotech is poised to bring hope by bringing a superior treatment to the market.

The results thus far are encouraging enough. 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 of the study's patients increased from 18% to 36%.

The next step is the upcoming phase 2b clinical trial using Cell-in-a-Box® with low doses of the drug ifosfamide in hopes of providing patients with a treatment that meets a current unmet medical need in the treatment of advanced pancreatic cancer. The near 50,000 people in the United States alone who will be diagnosed with pancreatic cancer this year are anxiously awaiting the trial's results.

Read more articles and our research report on PharmaCyte Biotech at www.smallcapnetwork.com.

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