PharmaCyte Biotech Announces More Positive Tests Results for Its Pancreatic Cancer Clinical Trial Product Candidate to Satisfy FDA Requirements
Microencapsulated CYP 2B1-expressing cells + ifosfamide (PharmaCyte Biotech)Pancreatic Cancer
PharmaCyte Biotech (Formerly Known As Nuvilex), Inc. (NASDAQ: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, announced today that the empty capsule material that comprises its pancreatic cancer clinical trial product candidate does not cause systemic toxicity.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, “Another important study has been conducted and concluded. This time the study evaluated the potential toxicity of the capsule component of our CypCaps™ clinical trial product candidate. We are pleased to announce that there was no evidence of toxicity in this animal study in any of the parameters examined and that the study confirms previous data that the capsule material is inert.”
The study, which was performed by a third-party Contract Research Organization, involved the ISO compliant testing of an extract of empty cellulose sulphate capsules provided by Austrianova for potential acute systemic toxicity in mice, according to ISO 10993-11: 2017(E), an FDA recognized consensus standard. Upon intraperitoneal injection of capsule extract, the mice were observed for clinical signs of toxicity at 30 to 40 min, 1 hour, 2 hours and 4 hours post dosing on day 1. On days 2, 3, 7 and 14, all of the animals were observed once daily for clinical signs and twice daily for mortality.
The body weight of the mice was recorded prior to administration of the capsule extract on day 1 and on days 2, 3, 4, 7 and 14 during the observation period. At the end of observation period, all the animals were examined for signs of toxicity. The analyses revealed that none of the mice died or showed any clinical signs of toxicity or gross pathological changes as compared to control mice. Moreover, no treatment related changes were noted in body weight and percent change in body weight with respect to day 1 values and all animals revealed a normal increase in body weight during the observation period.
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 .
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