PharmaCyte Biotech CEO In Europe To Secure Orphan Designation With The European Medicines Agency

SILVER SPRING, Md., Oct. 07, 2015 (GLOBE NEWSWIRE) -- PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, announced today that Kenneth L. Waggoner, Chief Executive Officer of PharmaCyte Biotech, is currently in Europe ironing out the details that will secure the European Medicines Agency (EMA) Orphan Designation for PharmaCyte Biotech’s pancreatic cancer treatment.

PharmaCyte Biotech’s treatment for advanced pancreatic cancer consists of a unique encapsulation technology known as “Cell-in-a-Box®” in combination with an inactive chemotherapy drug (ifosfamide). The technology encapsulates living cells that have been genetically modified to convert ifosfamide into its active or “cancer-killing” form. The encapsulated cells are first implanted into a patient’s pancreas as close to the tumor as possible. Then ifosfamide is given intravenously as any other chemotherapy agent is, but at one-third the normal dose to eliminate side-effects usually associated with chemotherapy. When the blood carries the ifosfamide to the site of the tumor, activation of the ifosfamide takes place when it comes in contact with the encapsulated live cells - rather than in the liver where it is normally activated.

Waggoner said of his efforts in Europe, “Securing the Orphan Designation in Europe for our pancreatic cancer treatment is vital to our company, as we head into our Phase 2b clinical trial to treat advanced pancreatic cancer. With the Orphan Designation, PharmaCyte Biotech will be provided 10 years of marketing exclusivity throughout Europe for its pancreatic cancer treatment.”

PharmaCyte Biotech will now rely on Clinical Network Services, its Contract Research Organization (CRO) in Australia and Europe, to finalize the documents that will give PharmaCyte Biotech the Orphan Designation with the EMA. Once the European Commission has approved the documents, PharmaCyte Biotech will make an announcement.

About PharmaCyte Biotech

PharmaCyte Biotech is a clinical stage biotechnology company focused on developing and preparing to commercialize treatments for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box®”. This unique and patented technology will be used as a platform upon which treatments for several types of cancer and diabetes are being developed.

PharmaCyte Biotech’s treatment for cancer involves encapsulating genetically modified live cells designed to convert an inactive chemotherapy drug (ifosfamide) into its active or “cancer-killing” form. These encapsulated live cells are placed as close to a cancerous tumor as possible. Once implanted in a patient, ifosfamide is given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been placed. When ifosfamide, which is normally activated in the liver, comes in contact with the encapsulated live cells, activation of the ifosfamide takes place at the source of the cancer without any side effects from the chemotherapy. This “targeted chemotherapy” has proven remarkably effective and safe to use in past clinical trials.

In addition to developing a novel treatment for cancer, PharmaCyte Biotech is developing a treatment for Type 1 diabetes and Type 2 insulin-dependent diabetes. PharmaCyte Biotech plans to encapsulate a human cell line which has been genetically engineered to produce, store and secrete insulin on demand at levels in proportion to the levels of blood sugar in the human body. The encapsulation will be done using the Cell-in-a-Box® technology.

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