Approval is related to treatment in patients undergoing liver transplant.
Enzon Pharmaceuticals’ IND application regarding the use of recombinant human Mannose-Binding Lectin (rhMBL) for the prevention and treatment of severe infections in patients with low levels of MBL undergoing liver transplant treatment has been permitted.
“Given that MBL is secreted in the liver, there is a strong scientific rationale for its potential use in treating these patients,” points out Jeffrey H. Buchalter, chairman and CEO. “Further, MBL-deficient patients can be readily identified through protein measures and genotyping, which may provide an improved opportunity to personalize anti-infection treatment for immunosuppressed patients.”
rhMBL is a protein therapeutic being developed for the prevention and treatment of severe infections in individuals with low levels of MBL, explains Enzon. The company obtained exclusive worldwide rights, excluding the Nordic countries, for this product from NatImmune in October 2005. Enzon is thus responsible for the development, manufacture, and marketing of rhMBL.
Enzon reports that the results from Phase I studies conducted by NatImmune demonstrated that rhMBL replacement therapy was safe and had an attractive pharmacokinetic profile in MBL-deficient volunteers. The company is currently designing a clinical development program for rhMBL and predicts that trial enrollment will begin in soon.
This approval marks the second this year for rhMBL, which was already okayed for the prevention and treatment of severe infections in multiple myeloma patients with low levels of MBL undergoing high-dose chemotherapy and hematopoietic stem cell transplantation.
