Clinical studies 

Dilafor is currently carrying out a phase IIb clinical trial in Sweden and Finland within the indication labor induction. The study is a multi-center, double blind, placebo-controlled proof of concept study in term-pregnant first-time mothers with an unripe cervix that are planned for labor induction. The pregnant women will be randomized to either subcutaneous injection of tafoxiparin or placebo once daily up to one week prior to scheduled labor induction. The treatment is then followed by induction according to clinical practice, which is usually balloon catheter or hormonal treatment. The target is to enroll 170 pregnant women in the study. For further information on the study and participating clinical sites, please see:

https://clinicaltrials.gov/ct2/show/NCT04000438?term=PPL17&draw=2&rank=1

In 2018, a randomized phase IIB, double-blind, placebo-controlled, parallel-group, dose-finding study comprising a total of 370 women was completed. The study evaluated the effects of continuous infusion of tafoxiparin as an adjunct treatment to oxytocin for up to 36 hours in term pregnant, nulliparous women in order to treat primary slow progress of labor including prolonged latent phase and primary labor arrest. Tafoxiparin was shown to be safe and well tolerated amongst both women and children, but no statistically significant efficacy was observed in any of the dose levels studied. The data received indicate that the use of tafoxiparin as an emergency treatment may not be feasible and that a longer exposure period of tafoxiparin may be necessary to reach the efficacy achieved in previous in clinical trial. The full results from the study will be published in a scientific journal or at a medical congress at a later stage. For further information on the study, please see:

https://clinicaltrials.gov/ct2/show/NCT03001193?term=PPL07&rank=1

In 2009, an exploratory Proof of Concept phase II clinical study, comprising a total of 263 women, was completed.Tafoxiparin was shown to be safe and well tolerated, and analyses of the results indicate that treatment with tafoxiparin can provide beneficial effects in women induced into labor and women with need of oxytocin due to labor arrestor primary slow progress of labor. Most importantly, the results of the study gave Dilafor a solid base with which to plan in detail the further and ongoing clinical development program for a number of indications within the obstetric field. For further information on the study, please see: 

https://clinicaltrials.gov/ct2/show/NCT00710242?term=PPL02&rank=1

In 2015 and 2016,Dilafor performed and finalized additional phase I studies in Europe and Asia.The phase I studies were focused on the evaluation of the safety and pharmacokinetics of tafoxiparin using a multidosing schedule of tafoxiparin.The study demonstrated tafoxiparin to be safe and well tolerated and with a predictive pharmacokinetic profile. The outcomes of the studies were used in the planning of the global clinical trial program in two major indications: labor induction and labor arrest.