Cipher Pharmaceuticals Inc. (TSX: DND) today announced that it has reached the enrollment mid-point in its Phase III safety study of CIP-ISOTRETINOIN, the Company's novel, patented formulation of isotretinoin, which is used in the treatment of severe, nodular acne. To date, more than 400 patients have been enrolled. Achieving this milestone triggers a US$2.0 million milestone payment from Ranbaxy Pharmaceuticals Inc., Cipher's U.S. marketing and distribution partner.
"Our clinical investigators are doing an excellent job in patient recruitment and follow-up and we are pleased with the study's progress," said Dr. Jason A. Gross, Pharm.D., Vice President of Scientific Affairs for Cipher. "We look forward to working closely with Ranbaxy Pharmaceuticals as we advance this pivotal clinical study and prepare to submit the findings to the FDA."
The Phase III safety study is randomized, double-blinded trial comparing the safety profile of CIP-ISOTRETINOIN to an FDA-approved, commercially available isotretinoin product. The study is currently being conducted at 50 sites in the U.S. and Canada with a planned duration of 18 months. The study is being conducted under a Special Protocol Assessment that was granted by the U.S. Food and Drug Administration.
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