Obstetrics

Dalteparin (Fragmin®) shortens parturition time in pregnant women
The use of tafoxiparin for the treatment and prevention of protracted labor is based on clinical observations. Pregnant women, who are at risk of thrombosis, are treated with anticoagulant Low Molecular Weight Heparin (LMWH) such as dalteparin. Women thus treated have shown less prolonged parturition time when compared with untreated controls. However, the use of LMWH increases the risk of bleeding and is thus not recommended during labor.

Methods that reduce protracted labor are urgently needed 
Protracted labor is experienced in up to 40% of all deliveries, often resulting in the need for emergency interventions such as cesarean section and instrumental assistance, and may lead to serious complications for children and mothers. Such interventions are reported in 10 to 25% of all deliveries in high income countries. In addition, protracted labor is common in pregnancies terminating one week after expected delivery (22% of all pregnancies). Methods and products that normalize parturition time is an urgent clinical need! 

Tafoxiparin in clinical trials for the prevention and treatment of protracted labor
Dilafor has designed and produced tafoxiparin, a Low Anticoagulant Heparin devoid of clinically significant anticoagulative effects and intended for use at delivery. Studies have shown that tafoxiparin has the same stimulatory effect on isolated uterus strips and cervix cells as LMWH and heparin. The scope of the clinical observation and its application is covered by patent protection. The patent has been granted in the US, Europe and in major countries in the rest of the world. 
Tafoxiparin was produced on an industrial scale in 2004 according to international quality standards for pharmaceutical products (c-GMP) and documented for safe use in humans in non-clinical studies in 2005. The first clinícal Phase I study in man was conducted in healthy volunteers in 2006. No unexpected findings or adverse reactions were noted at the tested dose levels, which covered up to four times the administered dose given in the Phase II study in pregnant women. The results from this clinical trial for the treatment and prevention of protracted labor was presented in 2009. This will be followed by an extended Phase II program for dose-finding and length of treatment studies.