QSV, Alseres Sign Cethrin Mfg. Pact

QSV Biologics and Alseres Pharmaceuticals have signed a contract for the process development and cGMP manufacture of Cethrin for spinal cord injury. QSV will be responsible for technology transfer, process development and cGMP manufacture of Phase IIb/III clinical trial material. Alseres licensed the drug from BioAxone Therapeutics. Cethrin is a Rho inhibitor that stimulates axon regeneration.

Dr. Graeme Macaloney, QSV president and chief executive officer said, “This first-in-field therapy for acute spinal cord injury is an exciting breakthrough, given that there are no approved alternatives. We are proud to be providing the manufacture of this important spinal cord therapeutic for Alseres, which has received orphan drug designation from the FDA.”

“As Alseres prepares to initiate its Phase IIb/III clinical trials in acute spinal cord injury later this year, we believe that QSV provides technical know-how and value to this program-critical process,” said Mark Pykett, president and chief operating officer of Alseres.