Since PharmaCyte’s last press release describing the manufacturing process for its clinical trial product and the testing of that product, the data from the manufacturing process has been reviewed, analyzed and discussed in great detail among PharmaCyte’s management team, including the leader of its clinical development program in pancreatic cancer and designated Principal Investigator (PI) for the LAPC trial, Prof. Manuel Hidalgo of the Harvard Medical School, Austrianova’s management team (the manufacturer of the clinical trial product), cGMP Validation (PharmaCyte’s cGMP expert consulting firm), Eurofins Lancaster Laboratories (who produced the cells for PharmaCyte’s Master Cell Bank) and several consulting cellular biologists.
The data obtained to date from the encapsulation parameters of the manufacturing process itself indicate that the encapsulation portion of the process is fault free and reproducible, which is a fundamental requirement of the FDA.
On the advice of PharmaCyte’s cGMP expert, the company plans to conduct two additional and staggered manufacturing runs in order to maximize the chances for a successful IND submission given the novelty and complexity of the entire process. In the time since the last manufacturing run, which we reported on in January of this year, those involved with the manufacturing process have been concentrating on changes that can be made to improve the process.
We believe that these changes will improve the cGMP manufacturing process to the point that the entire process can be shown to be consistently reproducible and robust as required by the FDA, and to ensure that the end-products of these manufacturing runs will convert the cancer prodrug ifosfamide into its cancer-killing form as well as they should.
This intensive effort has involved several independent tests by Austrianova and Eurofins. The results of these tests strongly indicate that, after the suggested changes are implemented, positive results should be obtained. When the changes are made to the cGMP manufacturing process, they should significantly improve the growth of the cells obtained from the Master Cell Bank both before and after encapsulation takes place. PharmaCyte and Austrianova and its team of consultants are in the final stages of optimizing this aspect of the manufacturing process.
Meanwhile, PharmaCyte’s clinical development program in pancreatic cancer is progressing. As explained by Prof. Hidalgo, “PharmaCyte has a strong clinical trial program for pancreatic cancer. The trial design has been thoroughly vetted by a team of the best pancreatic cancer specialists in the country. I continue to lead PharmaCyte’s program in pancreatic cancer, and I am eager to get underway as its PI for the LAPC trial. Members of PharmaCyte’s team are working on various aspects of implementing the program. I remain excited about the potential that PharmaCyte’s technology can offer patients who are suffering from LAPC and am looking forward to what a successful trial may mean for the way some types of solid cancerous tumors are treated in the future.”
Source: Company Press Release