The tafoxiparin Phase II trial was designed to measure the effect on labor time after preventive treatment using the candidate drug. 263 women at 18 clinics in Sweden were included in a randomized, double-blind and placebo-controlled study, conducted over a two year period. The treatment, which was administered during the last phase of pregnancy, was shown to be safe and well tolerated. In the groups as a whole the labor time was shorter in the treated group, but did not reach statistical significance.
However, further analyses of results suggest that treatment with tafoxiparin provides beneficial effects, including: a statistically significant (p=0.04) reduction in the number of women with labor times in excess of twelve hours; fewer complications as a cause of protracted labor; and fewer caesarean sections as a result of protracted labor.
Dilafor's CEO, Anders Asell, commented, "By concluding this proof-of-concept study we have shown that tafoxiparin has the potential to solve an important unmet medical need. We will now start actively seeking a collaboration partner with whom we can carry out a Phase III program. Parallel to this we will continue to develop tafoxiparin within Dilafor."
About Dilafor AB
Established in 2003, Dilafor AB is a Swedish R&D company focused on developing pharmaceutical products from heparin derivatives with low anticoagulant activity. The company has a balanced product portfolio representing highly promising ideas and innovations. Each of the projects addresses important and unmet medical needs.
The project, tafoxiparin (DF01) for protracted labor, successfully concluded a clinicial Phase II study in July 2009. DF02, a drug candidate for the treatment of severe malaria, is presently in Phase I clinical development.
Dilafor is managed by senior staff with high academic credentials and
|SOURCE Karolinska Development AB PUBL|
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