Date: 2012-02-10
Type of information: Initiation of preclinical development
phase: 2
Announcement: discontinuation of a study
Company: Pharming (The Netherlands) - Santarus (USA)
Product: Ruconest® (Rhucin® in non-European territories - conestat alfa)
Action
mechanism: enzyme inhibitor. Ruconest® is a recombinant version of the human protein C1 inhibitor (C1INH). It is produced through Pharming’s proprietary technology in milk of transgenic rabbits.
Disease: antibody-mediated rejection (AMR) after kidney transplantation
Therapeutic area: Transplantation
Country:
Trial
details:
Latest
news: Pharming has announced that the Company and its U.S. collaborator, Santarus, Inc., have discontinued a proof-of concept Phase II study in antibody-mediated rejection (AMR) after kidney transplantation. Recent improvements in clinical practice that significantly reduced the apparent incidence of AMR in renal transplant have decreased the need for therapeutic intervention, making patient recruitment for the clinical study difficult. Pharming is continuing to evaluate rhC1INH for other potentially commercially attractive indications, such as ischemia reperfusion injury related indications and promising new platform derived projects like rhFVIII. Reperfusion injury is a complication arising from oxygen shortage due to an interruption of the blood supply (ischemia) resulting in tissue damage. This can occur in a transplante d organ, in the brain, in case of stroke, and in the heart, in case of myocardial infarction (heart attack). Pharming has investigated the efficacy of rhC1INH in various pre-clinical reperfusion injury models with encouraging results and has recently (December 12, 2011) been granted a U.S. patent expiring in 2028, covering a method of preventing, reducing or treating an ischemia and/or reperfusion injury by administering certain recombinantly expressed C1 inhibitors (Ruconest®/ Rhucin®). This was Pharming’s first patent granted on ischemia/reperfusion injury in the U.S., and represents a significant milestone in the continuing development of the Company’s C1 inhibitor franchise in additional indications associated with the broad area of reperfusion injury.
