SOURCE: PharmaCyte Biotech, Inc.

June 03, 2015 09:30 ET

PharmaCyte Biotech's Cancer Treatment Shows "Complete Tumor Remission" in Published Preclinical Study

NEW YORK, NY--(Marketwired - June 03, 2015) - PharmaCyte Biotech’s (OTCQB: PMCB) signature live-cell encapsulation technology, Cell-in-a-Box®, was the star of the show in a recently released corporate video by the company. In that video, PharmaCyte revealed that its cancer treatment of Cell-in-a-Box® plus low doses of the anticancer drug ifosfamide was able to produce “complete tumor remission in all animals” that received the treatment on days 2-6 of a previously published preclinical study.

It was a study that used a colon cancer model to treat malignant ascites, a fluid that is common with abdominal cancers like pancreatic, colon, ovarian and liver cancer that accumulates in the abdominal cavity and causes painful swelling of the stomach. In PharmaCyte Biotech’s corporate video (www.PharmaCyte.com/media), renowned gastroenterologist and oncologist, Dr. Matthias Löhr of the famed Karolinska Institute in Stockholm, Sweden, says that he and a team of doctors and researchers found that they “could virtually cure malignant ascites” in this study.

Readers can find the published preclinical study in Cancer Gene Therapy here: http://www.nature.com/cgt/journal/v13/n1/full/7700849a.html

The preclinical study, commissioned by Bavarian Nordic, used “targeted chemotherapy” to treat malignant ascites just as PharmaCyte biotech does. In the study, words like “complete tumor remission” and “cure” were used to describe the results, so why didn’t Bavarian Nordic continue on with its work?

Well, at the time of the study, Bavarian Nordic, the forerunner to Austrianova, had three in-house technologies: (i) the encapsulation technology; (ii) a retroviral vector technology; and (iii) a poxvirus based delivery platform. As a result of the attacks of 9/11 in the United States, Bavarian Nordic decided to focus strategically on the development of a smallpox vaccine based on its poxvirus platform and chose to divest the other two technologies, which eventually were moved into Austrianova.

Austrianova GmbH, based in Europe then, was focused on one big indication -- namely pancreatic cancer. Executives at Austrianova made the decision then to go straight into a pivotal Phase 3 clinical trial in pancreatic cancer, which would have cost the biotech about $40 million. Austrianova was also working on setting up the GMP manufacturing facility in Frankfurt, Germany, and the firm was working on a veterinary clinical trial in mammary cancer.

Prof. Dr. Walter Gunzburg, the Chairman and Chief Technical Officer at Austrianova, said that the company didn’t have the manpower or the resources to work on malignant ascites in addition to all of its other planned activities. “Despite the exciting results in ascites published by Dr. Matthias Löhr, the financial resources available to the company (Austrianova GmbH) in Europe at that time didn't allow us to pursue this indication. We are very glad that PharmaCyte Biotech has now taken up the baton and is again exploring the use of the Cell-in-a-Box® technology to develop a clinical treatment for malignant ascites.”

If this study sounds familiar, it’s because PharmaCyte is currently in preclinical studies with Translational Drug Development (TD2) in Scottsdale, Arizona, to study how effective its treatment can be on the accumulation of malignant ascites. Dr. Löhr, who is now the Chairman of PharmaCyte Biotech’s Scientific Advisory Board, has been involved with the TD2 study from day one.

In the TD2 study, the company is using an ovarian cancer model and working to develop the parameters needed to enter into clinical trials. Based on comments in press releases from PharmaCyte’s CEO, Kenneth L. Waggoner, the company’s treatment appears promising, and plans are being made to enter the clinic to tackle the challenges that malignant ascites presents to patients who have abdominal tumors.

While the studies performed by Dr. Löhr and his team using the colon cancer model were more than 10 years ago, it is quite stunning to hear that they were not only able to “virtually cure malignant ascites” but they also saw “complete tumor remission in all animals” treated with Cell-in-a-Box® (known as Capcell then) and low doses of ifosfamide on days 2-6.

It’s stunning because more than 10 years ago Cell-in-Box® wasn’t nearly as developed as it is today. The technology is much improved in 2015 with capsules that are completely full with active live cells. So, with a more “potent” Cell in a Box® today, patients suffering from malignant ascites from one of the abdominal tumors that causes the accumulation of this fluid, must be elated to see PharmaCyte Biotech reviving the studies to treat this condition where there is currently no treatment available other than the painful and expensive periodic removal of the fluid in a hospital setting.

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