Pharmacyte Biotech Inc (OTCMKTS:PMCB) commenced the physical parameter testing of CypCaps as per US FDA recommendations. CypCaps shall be used for the treatment of pancreatic cancer.
FDA directs to develop two additional methods
The US FDA directed Pharmacyte to develop two additional tests to find the physical strength of CypCaps (encapsulated cells), which shall be used in the clinical study in patients with LAPC (Locally Advanced Pancreatic Cancer).
In the first method, the pressure will be applied to the capsules to check whether they deform or burst. The company incorporated machinery to measure the tiny changes because CypCaps are very small.
In the second technique, water is allowed to flow into the CypCaps. The company identifies the point at which the capsules get exploded.
These two test methods are outside the normal conditions for the capsules inside a human body. The company formed these tests to simulate the hypothetical conditions.
According to the results of the previous tests, CypCaps do not get exploded even under high-pressure conditions. Even if the capsules are open under these conditions, the immune system treats the cells as foreign bodies.
FDA recommended tests are necessary to ensure CypCaps reproducibility. Kenneth L. Waggoner, CEO of Pharmacyte said the company is excited to develop these two additional test methods and incorporated them into quality testing.
Commences additional studies
Pharmacyte commenced additional tests to identify the DNA encoding sequence of the enzymes in CypCaps cells as recommended by the US FDA. The cell clone, which is used to manufacture CypCaps, is strengthened to release the cytochrome P450 enzyme.
The cytochrome P450 enzyme is responsible for converting ifosfamide to cancer-killing form from its inactivate state. Pharmacyte demonstrated how the enzyme is produced and stable over time so that it is functional.
Pharmacyte is now asked by the FDA to show the exact DNA sequence as well as the genetic augmentation to release cytochrome P450. To demonstrate this, the company needs to employ state-of-the-art and new technique. The information obtained from these tests will certify the data already demonstrated to the US FDA.
Pharmacyte engages in the development of cellular therapies for the treatment of diabetes and cancer using its Cell-in-a-Box technology.
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