SEATTLE and YONGIN, South Korea/PRNewswire/ -- Curevo, a Seattle-based biotechnology company owned by GC Pharma, one of the largest therapeutic protein manufacturers in the world, announced today that the U.S. Food and Drug Administration (FDA) has advanced the company's Investigational New Drug (IND) application for CRV-101. The vaccine candidate for the prevention of herpes zoster (shingles) is now cleared to proceed into a Phase 1 clinical trial in healthy adults.
Curevo, along with Seattle-based collaborator Infectious Disease Research Institute (IDRI), is on track to initiate the Phase 1 trial in the fourth quarter of 2018 in the United States.
"While there have been significant recent advances in the development of new shingles vaccines, there remains a need to continue innovating novel strategies for this important health priority," said Corey Casper, MD, MPH, CRV-101 Project Leader at Curevo and IDRI's Chief Scientific Officer. "This large Phase 1 study will allow us to study whether CRV-101 is safe and well-tolerated in healthy adults, and to characterize the immune response to vaccination. This vaccine has been engineered with the latest advancements in protein science and immune stimulating molecules that we think should make it highly effective while minimizing the side effects that often accompany shingles vaccination."
Shingles typically presents as a painful blistering rash that develops on one side of the body, as a result of reactivation of the virus that causes chickenpox. The risk of shingles increases as of 50 years of age. There are currently two immunization options for the prevention of shingles available in the U.S.