Promising Results from Phase II Trial Show New Treatment from Dilafor Prevents Protracted Labor in Childbirth

2009-09-03

STOCKHOLM - September 3, 2009. Dilafor AB, a Karolinska Development portfolio company, today announced it has concluded a Phase II study of the drug candidate tafoxiparin (DF01), a new drug substance developed for the prevention of protracted labor during childbirth. Results from the study indicate that tafoxiparin reduces the incidence of protracted labor. The treatment, which was administered during the last phase of pregnancy, was also shown to be safe and well tolerated.

The randomized, double-blind and placebo-controlled clinical trial, which was conducted over two years on 263 women at 18 clinics in Sweden, was designed to measure the effect on labor time after preventive treatment with tafoxiparin.

Analyses of the results suggest that treatment with tafoxiparin provides beneficial effects. The effects observed in the study included the following.

• The number of women with protracted labor - labor times in excess of 12 hours -was significantly (p=0.04) lower amongst women treated with tafoxiparin.
  
  
• The number of complications as a cause of protracted labor, such as the need for vacuum extraction, was lower in women treated with tafoxiparin.
  
  
• The number of caesarean sections, as a cause of protracted labor, was lower in women treated with tafoxiparin.

Giving birth is a complex and unique process and an explorative clinical trial has neve before used labor time as a variable for measuring efficacy. The major difficulty is in determining the starting point of labor. No unambiguous medical cause exists for how to determine which women run the risk of protracted labor during birth. The study was, therefore designed to measure all birth labor times. Large variations of all endpoints were observed. Although a numerical difference in time of labor was seen for women treated with tafoxiparin compared with those who received placebo it was not statistically significant.

Gunvor Ekman-Ordeberg, M.D., PhD, one of the founders of Dilafor and professor at Karolinska Sjukhuset, commented, "A prolonged labor time is one of the most significant causes of complications during childbirth. Emergency interventions are carried out when mother and child are in distress, which puts both mother and child at risk. In addition, protracted labor also results in much pain and suffering. No treatments currently exist for preventing or mitigating these serious issues."

Dilafor CEO, Anders Åsell, added, "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."

Conny Bogentoft, CEO of Karolinska Development, which is the majority owner of Dilafor, commented, "This is a very important step for both Dilafor and Karolinska Development as it means we now have a clinically-active new drug candidate on our hands. It also goes a long way towards validating the Karolinska Development business model. Tafoxiparin has gone from innovative idea through to clinical proof of concept in only six years, demonstrating both the speed and efficiency of the model."