|Delayed - 09/18 03:59:45 pm|
PharmaCyte Biotech : FDA Formally Accepts PharmaCyte Biotech's Drug Master File for Company's Pancreatic Cancer Therapy
|08/06/2020 | 05:51am|
PharmaCyte's Chief Executive Officer,
'We now look forward to presenting the FDA with our Investigational New Drug Application very soon for our planned clinical trial in locally advanced, inoperable pancreatic cancer.'
A DMF is submitted to the FDA to provide detailed information about facilities, processes and materials used in the manufacturing, processing and packaging of human drugs. It is a prerequisite to securing approval and commercialization and ensures confidentiality of proprietary information related to the Active Pharmaceutical Ingredient (API). The information contained in a DMF is used to support, among other things, an IND.
The DMF requirements are complex and specific, encompassing every detail involved with the manufacture of the API - from raw materials to analytical methods, process development and optimization. The scrutiny goes all the way back to the starting materials used in the API.
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. This 'targeted chemotherapy' has proven effective and safe to use in past clinical trials and results in little to no treatment related side effects.
PharmaCyte's therapy for Type 1 diabetes and insulin-dependent Type 2 diabetes involves encapsulating a human liver cell line that has been genetically engineered to produce and release insulin in response to the levels of blood sugar in the human body. PharmaCyte is also considering the use of genetically modified stem cells, as well as beta islet cells, to treat diabetes. The encapsulation whatever cell line shows the most promise will be done using the Cell-in-a-Box technology. Once the encapsulated cells are implanted in a diabetic patient, we anticipate that they will function as a 'bio-artificial pancreas' for purposes of insulin production.
This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words 'expects,' 'anticipates,' 'believes,' 'intends,' 'estimates,' 'plans,' 'will,' 'outlook' and similar expressions. Forward-looking statements are based on management's current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement because of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements due to the impact of numerous risk factors, many of which are discussed in more detail in our Annual Report on Form 10-K and our other reports filed with the
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