Pharmacyte Biotech Inc (OTCMKTS:PMCB) has approached the U.S. FDA and seeks a pre-IND meeting with the entity. After years of focusing on live-cell encapsulation know-how, Cell-in-a-Box®, and fine-tuning its clinical trial design and therapy, the small biotech firm has arrived at the final evaluation before it can commence its pivotal clinical study in advanced pancreatic cancer.

The highlights

PharmaCyte made 2 recent statements that would be notable for any firm, but for a small biotech, these announcements are significant for investors who have been waiting it for long. First, it reported that oncologist, Dr. Manuel Hidalgo, has accepted to be the Principal Investigator for company’s planned clinical study. And the firm followed up that update with the report that it has requested a pre-IND discussion with the U.S. FDA for its imminent pancreatic cancer clinical study.

In PharmaCyte’s clinical study, Dr. Hidalgo will team up with reputed pancreatic cancer professional Dr. Daniel Von Hoff. He is the Chief Development Officer at TD2, the country’s premiere oncology CRO and the firm responsible for performing and organizing company’s clinical trial.

Dr. Hidalgo and Dr. Von Hoff worked in association on the clinical studies that took the industry what is currently the gold standard and the FDA sanctioned cure for advanced pancreatic cancer, ‘Abraxane® plus gemcitabine’.

PharmaCyte has named few clinical trial sites being considered for the trials. These sites comprise the Mayo Clinic in Scottsdale, the Beth Israel Deaconess Cancer Center, the Dana-Farber Cancer Institute, the Baylor Cancer Center, the City of Hope Cancer Center and sites in Spain and Germany. The company’s pancreatic cancer regimen is comprised of pinhead-sized, porous capsules that are packed with genetically modified cells. These cells work as a type of “artificial liver.”

Also, the company’s Cell-in-a-Box® do not comes in the list of drug delivery mechanism. It has no drugs captured inside the porous capsules for treatments. Instead, they are filled with nearly 10,000 live cells that are efficient of converting ifosfamide into its active cancer-killing form.