CrystalGenomics Receives US FDA Approval for Phase 2 Clinical Trial in Pancreatic Cancer

[Asia Economy Reporter Hyungsoo Park] CrystalGenomics announced on the 17th that it has received approval from the U.S. Food and Drug Administration (FDA) for the investigational new drug application (IND) to conduct a Phase 2 clinical trial of its pancreatic cancer drug candidate, Ivaltinostat.

The Phase 2 clinical trial for pancreatic cancer will be conducted on 70 patients with advanced or metastatic pancreatic cancer who have received the first-line standard treatment regimen FOLFIRINOX and whose disease has not progressed. The trial will compare a test group receiving a combination of Ivaltinostat and Roche's capecitabine with a control group receiving capecitabine monotherapy. Progression-free survival (PFS), disease control rate (DCR), overall survival (OS), and safety will be evaluated.

Dr. Andrew Ko, MD, at the University of California, San Francisco (UCSF), will serve as the principal investigator. Patient recruitment will take place at 25 university hospitals and cancer centers including UCSF, UCLA, and Duke University Medical Center.

The standard FOLFIRINOX regimen is difficult to continue for more than 4 to 6 months due to toxic side effects, even if effective. Pancreatic cancer has low responsiveness to chemotherapy or radiation therapy, and surgical resection is only possible in cases of localized progression.

Since only 10% of all pancreatic cancer patients have locally advanced disease, new treatments are needed for the remaining 90%. The incidence of pancreatic cancer is increasing in the U.S., and it is predicted to be the second leading cause of cancer-related death by 2030.

Ivaltinostat was designated as an orphan drug (ODD) by the U.S. FDA in 2019 due to its medical significance, safety, and product potential for pancreatic cancer indications. This designation provides various benefits including tax credits, waiver of new drug application fees, and seven years of market exclusivity after approval.

A CrystalGenomics representative stated, "To recruit patients for the Phase 2 pancreatic cancer trial quickly and smoothly, the trial will be conducted at up to 25 hospitals," adding, "Our top priority is to secure objective data, and we will explore the possibility of technology transfer to overseas pharmaceutical companies."

This content was produced with the assistance of AI translation services.