- PharmaCyte Biotech ( NASDAQ: PMCB ) said it had begun the pilot phase of its two-phase pig study of CypCaps to treat pancreatic cancer.
- ( PMCB ) stock up ~4% before the bell.
- The U.S. Food and Drug Administration has requested data from a large animal, such as a pig, to lift the clinical hold on PharmaCyte’s planned Phase 2b clinical trial for locally advanced, inoperable pancreatic cancer.
- The company will conduct the study in two phases - the first phase, which began on Thursday, is a short pilot study in two pigs.
- "The data obtained from the pilot study will allow us to finalize the full-scale pig study protocol, which will involve 90 pigs. We will then present the protocol to the FDA in our planned Type A meeting which will provide us an opportunity to interact with the FDA to receive guidance on this and several other outstanding issues relating to the clinical hold," said the company.
- PharmaCyte’s therapy for cancer involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or "cancer-killing" form.
- The CypCaps used in the study will contain radiopaque microspheres, which will be evaluated to track the movement of the CypCaps.
For further details see:
PharmaCyte Biotech begins first phase of two-phase animal study to treat pancreatic cancer