The Chief Executive Officer of PharmaCyte explained retention of Facet, “After we completed much of the Chemistry, Manufacturing and Control (CMC) work for PharmaCyte’s pre-IND submission to the FDA, we decided that PharmaCyte needed to retain a life sciences consulting firm that could guide it in a broad spectrum of areas that will be required for the successful development of PharmaCyte’s therapy for pancreatic cancer.
“Facet’s initial efforts to date have included assembling all of the preclinical and clinical data available on PharmaCyte’s therapy for pancreatic cancer and submission to the FDA as a ‘pre-IND package.’ Subsequently, Facet made arrangements with the FDA for the pre-IND meeting with the FDA and played a significant role in the meeting. We are extremely pleased with Facet’s performance and are convinced, based upon the results of the FDA meeting, that we made the right selection in retaining Facet.”
The Facet Life Sciences team is comprised of drug development, regulatory affairs and regulatory writing experts who have scientific degrees and over 100 years of combined experience in the pharmaceutical, biologics, biopharmaceutical and medical device industry. The services offered by Facet span the full spectrum of services that PharmaCyte will need for regulatory approval of its therapy for pancreatic cancer. Facet is the U.S. Agent for PharmaCyte before the FDA and will assist with regulatory and clinical strategy, preparation and support for regulatory meetings, regulatory submission leadership, gap analyses, product labeling, risk management and medical writing in a number of areas.
The President and CEO of Facet, Ken VanLuvanee, commented on Facet’s retention by PharmaCyte saying, “We are extremely pleased to have been selected to work with PharmaCyte on its novel live-cell encapsulation therapy for pancreatic cancer. This is cutting edge technology that presents one of the most complex regulatory product candidates on which we have ever worked. In spite of its complexity, when compared to a single chemotherapy drug for example, we believe that successful development of PharmaCyte’s therapy may change the way tumors of the pancreas and other solid tumors are treated in the future. It’s truly an exciting time for us and PharmaCyte alike.”
Facet development experts work closely with client teams to successfully reach their corporate and product goals. Facet has created and managed critical development aspects for some of the industry’s fastest growing life sciences companies. Its specialists deliver expert services and cutting-edge technologies that are designed to help small life science companies with big goals optimize their product research and development efforts.
About PharmaCyte Biotech
PharmaCyte Biotech is a clinical stage biotechnology company developing 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. These encapsulated cells are implanted as close to the patient’s cancerous tumor as possible. 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 comes in contact with the encapsulated cells they act as an artificial liver and activate the chemotherapy drug at the source of the cancer. This “targeted chemotherapy” has proven effective and safe to use in past clinical trials and results in little or no side effects.
In addition to developing a novel therapy for cancer, PharmaCyte is developing a therapy for Type 1 diabetes and insulin-dependent Type 2 diabetes. PharmaCyte plans to encapsulate 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 encapsulation will be done using the Cell-in-a-Box® technology. Once the encapsulated cells are implanted in a diabetic patient, they will function as a “bio-artificial pancreas” for purposes of insulin production.
This press release may contain forward-looking statements regarding PharmaCyte and its future events and results that involve inherent risks and uncertainties. The words “anticipate”, “believe”, “estimate”, “expect”, “intend”, “plan” and similar expressions, as they relate to PharmaCyte or its management, are intended to identify forward-looking statements. Important factors, many of which are beyond the control of PharmaCyte, could cause actual results to differ materially from those set forth in the forward-looking statements. They include PharmaCyte’s ability to continue as a going concern, delays or unsuccessful results in preclinical studies and clinical trials, flaws or defects regarding its product candidates, changes in relevant legislation or regulatory requirements, uncertainty of protection of PharmaCyte’s intellectual property and PharmaCyte’s continued ability to raise capital. PharmaCyte does not assume any obligation to update any of these forward-looking statements.
More information about PharmaCyte can be found at www.PharmaCyte.com. It can also be obtained by contacting Investor Relations.
PharmaCyte Biotech, Inc.
Investor Relations Department