Sym001 enters Ph I ITP and HDN trial

Danish biopharmaceutical firm Symphogen and Sweden's Biovitrum have initiated a Phase I clinical trial of their developmental antibody drug candidate Sym001 (anti-RhD) in healthy volunteers. The product, which comprises 25 different anti-Rhesus D antibodies, is being developed as a treatment for idiopathic thrombocytopenic purpura and as a preventative therapy for hemolytic disease of the newborn.

The firms explained that the study, which will seek to enroll 39 RhD positive and 18 RhD negative subjects, is a dose-escalation assessment of the product's safety and tolerability, when delivered as a single intravenous infusion. The program, which is being conducted at a clinic in the USA, will also establish the agent's pharmacodynamic profile, as well as any immune system response that it elicits.

Kirsten Drejer, Symphogen's chief executive, said that the progress of Sym001, which is the first recombinant polyclonal antibody product to enter clinical trials, is a clear validation of the firm's development platform. Biovitrum's chief executive, Matt Petterson, echoed this opinion, adding that the trial marks the sixth project that the company has in clinical trials. Final results are scheduled for the end of 2007.