Policy & Regulation
PharmaCyte Biotech Selects Medpace as CRO for Its Clinical Trial in Pancreatic Cancer
12 November 2018 - - US-based biotechnology company PharmaCyte Biotech, Inc. (OTCQB: PMCB) has selected contract research organisation Medpace, Inc. to conduct PharmaCyte's clinical trial in locally advanced, non-metastatic, inoperable pancreatic cancer, the company said.

Medpace is an established full-service CRO with expertise in numerous therapeutic areas focused on supporting the biotech sector.

It is a scientifically-driven organization with a dedicated in-house study team supported by outstanding medical experts to lead the way.

Medpace has an extensive portfolio of successfully completed clinical trials, including those involving pancreatic cancer.

Selection of the CRO for PharmaCyte's clinical trial in LAPC was performed by PharmaCyte's CTLT led by Dr. Linda Sher, PharmaCyte's Chief Medical officer, and Dr. Manuel Hidalgo who will serve as Principal Investigator for the trial. The selection process was both laborious and time-consuming.

Initially, 10 CRO candidates were identified. After an initial screening, this number was reduced to 8.

Thereafter, careful examination and scrutiny of the qualifications and references of the 8 candidates led to the selection of the top 4 candidates.

Each of the 4 remaining candidates was then sent a Request for Proposal to conduct the trial. After receiving the RFP proposals, interviews of the 4 remaining CROs were conducted by telephone.

Finally, an in-depth analysis by PharmaCyte's CTLT was conducted, which reduced the number of CRO candidates to the top 2. The top 2 CRO candidates were interviewed in person by members from the CTLT. Both candidates were outstanding and impressive.

The decision to select Medpace was unanimous among the members of the CTLT evaluation team. Although Medpace is a multidisciplinary full-service CRO, its largest therapeutic area of focus is in oncology, and it is very experienced in conducting pancreatic cancer clinical trials.

PharmaCyte Biotech is a clinical stage biotechnology company developing cellular therapies for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as "Cell-in-a-Box."

This technology will be used as a platform upon which therapies for several types of cancer and diabetes are being developed.

PharmaCyte's therapy for cancer involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or "cancer-killing" form.

For pancreatic cancer, these encapsulated cells are implanted in the blood supply to the patient's tumor as close as possible to the site of the tumor.

Once implanted, a chemotherapy drug that is normally activated in the liver (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 implanted. When the ifosfamide flows through pores in the capsules, the live cells inside act as a "bio-artificial liver" and activate the chemotherapy drug at the site of the cancer.

According to the company, this "targeted chemotherapy" has proven effective and safe to use in past clinical trials and results in no treatment related side effects.

PharmaCyte's therapy for Type 1 diabetes and insulin-dependent Type 2 diabetes involves encapsulating a human cell line that has been genetically engineered to produce, store and release insulin in response to the levels of blood sugar in the human body.

The cell lines being studied and developed are human liver cells, stem cells and beta islet cells. The encapsulation will be done using the Cell-in-a-Box technology.

Once the encapsulated cells are implanted in a diabetic patient, they are designed to function as a "bio-artificial pancreas" for purposes of insulin production.

Medpace is a scientifically driven, global, full-service clinical contract research organization providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries.

The mission of Medpace is to accelerate the global development of safe and effective medical therapeutics through its high-science and disciplined operating approach that leverages local regulatory and deep therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system and anti-viral and anti-infective.

Headquartered in Cincinnati, Ohio, Medpace employs approximately 2,800 people across 36 countries.
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