[Asia Economy Reporter Hyungsoo Park] CrystalGenomics announced on the 20th that it has submitted a plan for a Phase 2 clinical trial to the U.S. Food and Drug Administration (FDA) to confirm the therapeutic effect of its anticancer drug candidate 'Ivaltinostat' on pancreatic cancer.
The Phase 2 pancreatic cancer trial will be conducted at 25 medical institutions across the United States, targeting 58 patients with metastatic or advanced pancreatic cancer who have received standard treatment. The trial will compare a test group receiving a combination of Ivaltinostat and Roche's capecitabine with a control group receiving capecitabine monotherapy.
Capecitabine is an anticancer drug used for various cancers such as colon cancer, breast cancer, and stomach cancer. The primary evaluation indicators include progression-free survival (PFS), disease control rate (DCR), overall survival (OS), and safety assessment through Ivaltinostat compared to the control group.
The principal investigator for the Phase 2 clinical trial is Professor Andrew Ko, MD, from the University of California, San Francisco (UCSF), who will conduct the trial targeting patients with advanced or metastatic pancreatic cancer.
The latest trends in pancreatic cancer research focus on maintaining tumor suppression effects after standard treatment while improving patients' quality of life. The lower the toxicity during anticancer treatment and the higher the disease control rate of pancreatic cancer through the therapeutic agent, the more it helps maintain patients' quality of life.
According to the global market research firm Mordor Intelligence, the global pancreatic cancer treatment market size is projected to reach $2.3 billion (approximately 2.7 trillion KRW) by 2026.
A CrystalGenomics official stated, "The goal of the clinical trial is to find an optimized anticancer maintenance therapy by administering a combination of Ivaltinostat, an anticancer drug candidate confirmed for tolerability and safety, and capecitabine, as a regimen that can maintain anticancer effects and quality of life for pancreatic cancer patients."
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