FDA Changes ImmunoCellular Study CalendarMonday, March 6, 2017
ImmunoCellular Therapeutics Ltd. on Monday announced that the U.S. Food and Drug Administration has approved an amendment to its registration trial for a drug, temporarily sending the company’s stock up 16 percent.
The Calabasas company said the change for its ICT-107 phase 3 registration trial in newly diagnosed glioblastoma brain tumors will allow patients to be randomized 30 days after screening procedures instead of 90 days after, which should accelerate the FDA process by approximately two months, potentially quickening the time to market for the treatment.
“We are pleased to announce that the amendment is currently being implemented at U.S. clinical sites and that amended protocol submissions are underway in Europe and Canada,” Chief Executive Dr. Anthony Gringeri said in a statement.
In addition, the company reported the successful completion of its first milestone in its Stem-to-T-cell program, which utilizes a specific gene expected to enhance a patient’s immune system to ultimately attack cancer-causing tumors.
ImmunoCellular (IMUC) shares, which traded as high as $2.96, settled down to close up 6 cents, or 2.4 percent at $2.61 on the New York Stock Exchange.