Pharmacyte Biotech Inc (OTCMKTS:PMCB) has presented its pre-Investigational New Drug conference bundle to the U.S. FDA for its therapy in LAPC that is inoperable. This step comes next to its recent update that the U.S. FDA has given firm a pre-IND conference for its pancreatic cancer treatment. The package allows the FDA to know a full history of firm’s therapy, comprising info on the previous clinical trials and preclinical studies that were performed applying the Cell-in-a-Box® technology together with low doses of drug ifosfamide.
It should be known that the drug ifosfamide and Cell-in-a-Box® technology together makes up firm’s pancreatic cancer treatment. This helps to get detailed data on the manufacturing mechanism used to get the Cell-in-a-Box® capsules. It marks a synopsis of the clinical trial structure that company will perform in the U.S. and Europe.
The FDA’s retort to the pre-IND application will be given after the completion of pre-IND meeting. Its response will work as a roadmap in leading company as it sets the full IND submission that must be seen appropriate to the FDA before the launch of clinical trial.
Pharmacyte’s CEO Kenneth L. Waggoner reported that the pre-IND package application marks a notable initiative that they have completed in its plans to get pancreatic cancer therapy. They are looking forward to this pre-IND discussion and the guidance of the U.S. FDA as they set for their clinical trial in subjects with inoperable LAPC. Here it is important to mention that inoperable LAPC is one of the areas of unmet medical need that the medical industry still had to address.
Pharmacyte Biotech is also working on a regimen for insulin-dependent Type 2 diabetes and Type 1 diabetes. It seeks to encapsulate a cell line of hum that has been inherently engineered to produce, store and discharge insulin in reaction to the blood sugar levels in the human body.