Karolinska Development Portfolio Company Completes Successful Phase II Clinical Trial

2009-09-04

STOCKHOLM - September 4th, 2009. Karolinska Development (publ) today announced that one of its portfolio companies, Dilafor AB, has concluded an extensive clinical study of its candidate drug, tafoxiparin, a new drug substance for the prevention of protracted labor during childbirth. The promising results of the Phase II trial bring the project closer to exit in line with Karolinska Development's business strategy

Dilafor's candidate drug, tafoxiparin DF01 is one of 11compounds within the Karolinska Development portfolio that are currently conducting clinical trials. The completion of the Dilafor study is an important milestone for Karolinska Development and exemplifies the company's ability to develop innovative ideas through to clinical proof of concept quickly and efficiently. In the case of Dilafor, tafoxiparin has taken just six years to go from research concept to its current stage.

Karolinska Development's portfolio consists of more than 40 life science companies. A unique business model, which gives portfolio companies access to a broad network of business, legal, regulatory and scientific expertise, means that development times and costs are reduced compared to traditional drug development programs. With seven compounds currently undergoing Phase II clinical trials and five in Phase I the portfolio has matured to the point that Karolinska Development is now actively seeking commercial partners for its most advanced projects.

Conny Bogentoft, CEO of Karolinska Development, said, "The completion of the Dilafor Phase II trial is an important step for Karolinska Development and we are extremely pleased that Dilafor has achieved some very positive results. At the same time, it also goes a long way towards validating our business model. We are now very much focused on finding commercial opportunities for Dilafor's tafoxiparin and for several of our other projects that are reaching maturity."

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 Åsell, 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."