Geron期望肿瘤疫苗的I期试验在一周内开始
NEW YORK (Reuters Health) - Geron Corp. expects to begin a phase I trial of an investigational cancer vaccine in one week, which would mark the first product from the company's cancer therapeutics pipeline to advance into human trials.
Speaking here at the UBS Warburg Global Life Sciences Conference, Dr. Thomas Okarma, president and CEO of Geron, said that the company filed an investigational new drug application on the vaccine with the US Food and Drug Administration (FDA) about three weeks ago.
He told Reuters Health that the agency has a 30-day window in which to raise objections to the filing. "Unless we hear otherwise [from the FDA], we [are] seven days away from beginning that trial at Duke University."
The trial will investigate Geron's telomerase vaccine in patients with hormone-refractory prostate cancer. The product is designed to stimulate a patient's immune system to create T-cells against cancer cells that express telomerase, an enzyme largely responsible for controlling the replication ability of all cells.
Dr. Okarma added that the vaccine has already demonstrated, in laboratory studies using human and animal models, the ability to prompt immune cells to attack their own cancer cells.
During late morning trading on the NASDAQ, shares of Menlo Park, California-based Geron were up 0.97 at 13.27, an increase of almost 8%., 百拇医药
Speaking here at the UBS Warburg Global Life Sciences Conference, Dr. Thomas Okarma, president and CEO of Geron, said that the company filed an investigational new drug application on the vaccine with the US Food and Drug Administration (FDA) about three weeks ago.
He told Reuters Health that the agency has a 30-day window in which to raise objections to the filing. "Unless we hear otherwise [from the FDA], we [are] seven days away from beginning that trial at Duke University."
The trial will investigate Geron's telomerase vaccine in patients with hormone-refractory prostate cancer. The product is designed to stimulate a patient's immune system to create T-cells against cancer cells that express telomerase, an enzyme largely responsible for controlling the replication ability of all cells.
Dr. Okarma added that the vaccine has already demonstrated, in laboratory studies using human and animal models, the ability to prompt immune cells to attack their own cancer cells.
During late morning trading on the NASDAQ, shares of Menlo Park, California-based Geron were up 0.97 at 13.27, an increase of almost 8%., 百拇医药