This is the second FDA-required test on the product that will be used in the company's planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC).
PharmaCyte's Chief Executive Officer,
Regulatory agencies around the world, including the FDA, require a shelf-life determination for all medical products. Living products, like cell therapies such as CypCaps, are particularly sensitive and more prone to inactivation over time. Accordingly, it is especially important to determine the shelf-life for PharmaCyte's clinical trial product.
The FDA specifically required a CCI test be run on PharmaCyte's clinical trial product and that the data from the CCI test be included in an ongoing basis in PharmaCyte's IND.
More can be read about the specifics of the CCI test in PharmaCyte's
To learn more about PharmaCyte's pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, we encourage you to watch the company's documentary video complete with medical animations at: https://www.PharmaCyte.com/Cancer
About
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 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.
Safe Harbor
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that express the current beliefs and expectations of the management of PharmaCyte, including the timing and commencement of our planned Phase 2b clinical trial in LAPC, which is subject to IND approval. Any statements contained herein that do not describe historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results, performance and achievements to differ materially from those discussed in such forward-looking statements. Factors that could affect our actual results include our ability to raise the necessary capital to fund our operations and to find partners to supplement our capabilities and resources, our ability to submit and get approved our pending IND, as well as such other factors that are included in the periodic reports on Form 10-K and Form 10-Q that we file with the
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Contact:
Tel: 917.595.2856
Email: Info@PharmaCyte.com
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