Date: 2014-10-02
Type of information: Initiation of the trial
phase: 1-2
Announcement: initiation of the trial
Company: Prophylix Pharma (Norway)
Product: NAITgam
Action
mechanism: NAITgam comprises specific IgG antibodies against HPA-1a manufactured from the plasma of rare donors recruited from European and US blood banks. The donors are women who previously have given birth to a child who suffered from FNAIT. The antibodies in the prophylactic drug remove fetal HPA-1a positive platelets from the mother’s circulation before her immune system has had time to develop antibodies against the fetal platelets.
Disease: prevention of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
Therapeutic area: Hematological diseases - Autoimmune diseases
Country:
Trial details:
Latest
news: * On October 2, 2014, Prophylix Pharma announced that it will take its novel prophylactic NAITgam into Phase I/II trials in Q3 2015. NAITgam protects newborns against the rare but potentially crippling and fatal bleeding disorder called Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT). This condition occurs when a mother develops antibodies against her baby’s platelets. One of the most feared consequences of FNAIT is intracranial bleeding and this affects about 1000 pregnancies annually in the US and Europe. The decision follows FDA-approval of the company’s regulatory strategy to proceed with a greatly reduced clinical program. Prophylix will apply for Fast Track Designation and marketing authorization in 2018 is a realistic target. All that is needed is a single injection within the first 6 hrs after an HPA-1a negative woman has given birth to an HPA-1a positive child.
