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news.PharmaCyte Biotech reported that the encapsulation facility located in Bangkok, Thailand, that will be used to encapsulate the live cells used for PharmaCyte’s pancreatic cancer therapy has recently been inspected by the Food and Drug Administration of Thailand (Thai FDA).
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In its report on that inspection, the Thai FDA stated that, "The facility is built according to the pre-approved floor plan and is now deemed suitable for the manufacture of pharmaceutical products."
PharmaCyte Biotech CEO Kenneth Waggoner said: "We are very pleased that our partner, Austrianova, has received a positive opinion from the Thai FDA for Austrianova’s live-cell encapsulation facility. This is an important milestone in the development of PharmaCyte’s treatment for pancreatic cancer and a pre-requisite for our upcoming pancreatic cancer clinical trial."
The main role of the Thai FDA is to protect consumer’s health, especially, to ensure safety, quality and efficacy of health products within its purview. These products include: foods, drugs, psychotropic substances, narcotics, medical devices, volatile substances, cosmetics and hazardous substances.
It is an absolute requirement that the construction and operation of Austrianova’s live-cell encapsulation facility be in accordance with both Thai national legislation as well as international agreements.
PharmaCyte’s product for pancreatic cancer will be manufactured in Austrianova’s facility in Bangkok. It consists of live human cells that have been genetically engineered to convert the anticancer prodrug ifosfamide into its "cancer-killing" form and then encapsulated using the Cell-in-a-Box encapsulation technology.
In PharmaCyte’s upcoming clinical trial, these encapsulated live cells will be used with low doses of ifosfamide (one third the normal dose) as a "consolidation therapy" with the current standard of care for advanced pancreatic cancer when a patient no longer benefits from first line therapy.
PharmaCyte’s therapy will be compared with the combination of the anticancer drug capecitabine plus radiation in patients with locally advanced, non-metastatic, inoperable pancreatic cancer whose tumors are stable or progressing after 4-6 cycles of treatment with either the combination of Abraxane plus gemcitabine or the four-drug combination known as FOLFIRINOX.