Dilafor announces positive results from a multi dosing safety and pharmacokinetic clinical study
STOCKHOLM, SWEDEN – February 25, 2015. Dilafor AB, a Karolinska Development portfolio company, announced today the completion of a safety and pharmacokinetic multi dosing clinical study with the candidate drug tafoxiparin. The purpose of the study was to evaluate different clinical administration routes and different dose levels of tafoxiparin in healthy female volunteers. The results will give guidance on the dosages to be used in the Phase II trial in labor induction expected to start in end 2015.
The study was 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 with both subcutaneous and intravenous administration. The outcome of the study will be used in the planning of the global clinical trial program in two major indications; labor induction and labor arrest.
As a next step and as part of the clinical development program in Asia together with Lee’s Pharmaceuticals, tafoxiparin will be studied in a Phase II clinical trial in pregnant women that are induced into labor. Initiation of the study is expected in end of 2015, depending on approval from the Chinese Food and Drug Administration (CFDA). Meanwhile during 2015, a Phase I clinical safety study is planned in Asian women to further support the start of the Phase II study and to support the use of Asian clinical data in the global clinical development.
Including the finalization of the aforementioned safety and pharmacokinetic study, tafoxiparin has been used and shown to be safe in totally three clinical trials involving 335 subjects of whom 263 were term pregnant women.
“This study is an important milestone in the clinical strategy for development of tafoxiparin for obstetrical indications. The generated pharmacokinetic data and the supportive safety data give us excellent tools to decide about the design of the Phase II clinical trial” says Lena Degling Wikingsson, CEO at Dilafor AB.
For further information, please contact:
Lena Degling Wikingsson, CEO at Dilafor AB
Phone: +46 (0)70 790 02 07, e-mail: firstname.lastname@example.org
TO THE EDITORS
About Dilafor AB
Dilafor AB is a Swedish drug development company focusing on the development of tafoxiparin for obstetric indications. The company’s primary goal is to decrease the incidence of slow progress of labor both after induction of labor and after spontaneous onset of labor. The main owner of Dilafor is KDev Investments AB, owned by Karolinska Development AB (STO: KDEV) and Rosetta Capital. The other main owners are The Foundation for Baltic and European Studies (Östersjöstiftelsen) and Praktikerinvest. For more information, please visit: www.dilafor.com.
Tafoxiparin is a heparan sulphate mimetic, a propriety polysaccharide based drug developed by Dilafor. Women that experience protracted and complicated labor have deficiency in heparan sulphate which is a naturally occurring polysaccharide and plays an important role in labor. Preclinical and clinical data show that tafoxiparin fulfills the role of heparan sulphate and works in conjunction with naturally occurring molecules important in child birth. Slow progress of labor has an incidence of 45% of all pregnant women. It is associated with a number of both long and short term maternal and fetal complications such as emergency caesarean sections, postpartum hemorrhages, vaginal tears, anal ruptures, meconium-stained amniotic fluid and asphyxia. These complications lead to short and long term consequences for the mother and the newborn in addition to substantial health care costs.