An Exploratory, Open label, Randomized, Parallel-Group, Pilot Study to evaluate Safety, Tolerability and Efficacy of daily, subcutaneous tafoxiparin treatment from the time of diagnosis for up to 4 weeks, in pregnant women who are diagnosed with pre-eclampsia between the 26th and 32nd weeks of gestation. - PPL20

Start Date30 Mar 2021

Sponsor / Collaborator

Dilafor AB

NCT04000438 / CompletedPhase 2

Randomized, Placebo-Controlled, Proof of Concept Study to Evaluate the Efficacy on Cervical Ripening, Safety, Tolerability and Dose Response of SC Administered Tafoxiparin in Term Pregnant, Nulliparous Women With an Unripe Cervix Undergoing Labor Induction

The study is designed as a randomized, Double-Blind, Placebo-Controlled, Parallel-Group Proof of Concept Study (section A) with a conditional dose finding follow up (Section B) to Evaluate the Efficacy on Cervical ripening, Safety, Tolerability and dose response of Subcutaneously Administered Tafoxiparin in Term Pregnant, Nulliparous Women with an unripe cervix undergoing Labor Induction. If the efficacy and safety profiles of Section A are conclusive in favor of tafoxiparin, the study will continue by adding two additional tafoxiparin dose groups in Section B.

Start Date21 Jun 2019

Sponsor / Collaborator

Dilafor AB

EUCTR2016-002118-40-DK / Not yet recruitingPhase 2

Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Finding Study to Evaluate the Effect of continuous infusion of Tafoxiparin as an Adjunct Treatment to Oxytocin for up to 36 hours in Term Pregnant, Nulliparous Women to treat Primary Slow Progress of Labor including prolonged latent phase and Primary Labor Arrest

Start Date29 Sep 2017

Sponsor / Collaborator

Dilafor AB

100 Clinical Results associated with Tafoxiparin

100 Translational Medicine associated with Tafoxiparin

100 Patents (Medical) associated with Tafoxiparin

Literatures (Medical) associated with Tafoxiparin

05 Mar 2024·Microbiology Spectrum

Differential analysis of IBV-infected primary chicken embryonic fibroblasts and immortalized DF-1

Article

Author: Liu, Song ; Li, Hao ; Gong, Huiling ; Yan, Wenjun ; Wang, Kailu ; Huang, Siyu ; Wang, Hong-Ning ; Yang, Xin ; Yang, Qingcheng ; Lei, Chang-Wei

ABSTRACT Infectious bronchitis virus (IBV), the causative agent of infectious bronchitis, is responsible for major economic losses in the poultry industry worldwide. While IBVs can usually be passaged in primary chicken embryonic fibroblasts (CEFs), most of the wild ones cannot adapt to passaged cell lines. In this study, the wild strain CK/CH/MY/2020 was used to infect primary CEF and immortalize DF-1 CEF cells. Results indicated that IBV was able to cause lesions and pass onto CEF, but not DF-1. Indeed, the virus could enter DF-1 cells and synthesize the associated structural gene but could not assemble into complete viral particles for release. Furthermore, transcriptome sequencing analysis showed significant differences in gene expression between CEF and DF-1 cells after viral infection, although the corresponding antiviral responses could be activated in both cell types. The biggest difference was in terms of the amino acid biosynthesis pathway and the cytokine receptor interaction pathway, which were significantly and specifically activated in CEF. This could actually explain why intact viruses can be assembled but not in DF-1. In addition, SLBP and P2RX7 affect the replication of IBV’s structural genes to some extent. Overall, IBV can enter CEF and DF-1 cells, but the complex intracellular cytokine interactions affect the assembly and release of viral particles. The insight will be useful for the study of IBV through in vitro transmission and pathogenesis. IMPORTANCEInfectious bronchitis virus (IBV) is responsible for high morbidity and mortality as well as substantial economic losses worldwide. Transcriptome sequencing of IBV-infected chicken embryonic fibroblast and DF-1 cells revealed that the virus elicits antiviral immunity in cells after viral infection, but IBV cannot activate DF-1 cells to produce sufficient amounts of viral structures to assemble into complete virions, which may be caused by the interactions between cytokines. The study of IBV cellular adaptations is important for vaccine development and investigation of the pathogenesis of IBV.

01 Mar 2024·American Journal of Obstetrics and Gynecology

Tafoxiparin, a novel drug candidate for cervical ripening and labor augmentation: results from 2 randomized, placebo-controlled studies

Review

Author: Rahkonen, Leena ; Hallberg, Gunilla ; Ludvigsen, Mette ; Tihtonen, Kati ; Blomberg, Marie ; Uotila, Jukka ; Hellgren-Wångdahl, Margareta ; Jonsson, Maria ; Jeppson, Annika ; Pettersson, Karin ; Engberg, Malin ; Bejlum, Carina ; Ekman-Ordeberg, Gunvor

BACKGROUNDSlow progression of labor is a common obstetrical problem with multiple associated complications. Tafoxiparin is a depolymerized form of heparin with a molecular structure that eliminates the anticoagulant effects of heparin. We report on 2 phase II clinical studies of tafoxiparin in primiparas. Study 1 was an exploratory, first-in-pregnant-women study and study 2 was a dose-finding study.OBJECTIVEStudy 1 was performed to explore the effects on labor time of subcutaneous administration of tafoxiparin before onset of labor. Study 2 was performed to test the hypothesis that intravenous treatment with tafoxiparin reduces the risk for prolonged labor after spontaneous labor onset in situations requiring oxytocin stimulation because of dystocia.STUDY DESIGNBoth studies were randomized, double-blind, and placebo-controlled. Participants were healthy, nulliparous females aged 18 to 45 years with a normal singleton pregnancy and gestational age confirmed by ultrasound. The primary endpoints were time from onset of established labor (cervical dilation of 4 cm) until delivery (study 1) and time from start of study treatment infusion until delivery (study 2). In study 1, patients at 38 to 40 weeks of gestation received 60 mg tafoxiparin or placebo daily as 0.4 mL subcutaneous injections until labor onset (maximum 28 days). In study 2, patients experiencing slow progression of labor, a prolonged latent phase, or labor arrest received a placebo or 1 of 3 short-term tafoxiparin regimens (initial bolus 7, 21, or 35 mg followed by continuous infusion at 5, 15, or 25 mg/hour until delivery; maximum duration, 36 hours) in conjunction with oxytocin.RESULTSThe number of participants randomized in study 1 was 263, and 361 were randomized in study 2. There were no statistically significant differences in the primary endpoints between those receiving tafoxiparin and those receiving the placebo in both studies. However, in study 1, the risk for having a labor time exceeding 12 hours was significantly reduced by tafoxiparin (tafoxiparin 6/114 [5%] vs placebo 18/101 [18%]; P=.0045). Post hoc analyses showed that women who underwent labor induction had a median (range) labor time of 4.44 (1.2-8.5) hours with tafoxiparin and 7.03 (1.5-14.3) hours with the placebo (P=.0041) and that co-administration of tafoxiparin potentiates the effect of oxytocin and facilitates a shorter labor time among women with a labor time exceeding 6 to 8 hours (P=.016). Among women induced into labor, tafoxiparin had a positive effect on cervical ripening in 11 of 13 cases (85%) compared with 3 of 13 participants (23%) who received the placebo (P=.004). For women requiring oxytocin because of slow progression of labor, the corresponding results were 34 of 51 participants (66%) vs 16 of 40 participants (40%) (P=.004). In study 2, tafoxiparin had no positive effects on the secondary endpoints when compared with the placebo. Except for injection-site reactions in study 1, adverse events were no more common for tafoxiparin than for the placebo among either mothers or infants. There were few serious or treatment-related adverse events.CONCLUSIONSubcutaneous treatment with tafoxiparin before labor onset (study 1) may be effective in reducing the labor time among women undergoing labor induction and among those requiring oxytocin for slow progression of labor. Moreover, tafoxiparin may have a positive effect on cervical ripening. Short-term, intravenous treatment with tafoxiparin as an adjunct to oxytocin in patients with labor arrest (study 2) did not affect labor time or other endpoints. Both studies suggest that tafoxiparin has a favorable safety profile in mothers and their infants.

01 Dec 2023·American Journal of Obstetrics and Gynecology

Tafoxiparin, a novel drug candidate for cervical ripening and labor augmentation: results from 2 randomized, placebo-controlled studies: a reply

Letter

Author: Rahkonen, Leena ; Ekman-Ordeberg, Gunvor ; Jonsson, Maria

News (Medical) associated with Tafoxiparin

17 Jun 2021

·www.globenewswire.com

Karolinska Development increases book value of Dilafor that

STOCKHOLM, SWEDEN – June 17, 2021. Karolinska Development AB (Nasdaq Stockholm: KDEV) announces today that the company, based on an external valuation, will increase the book value of its holding in the portfolio company Dilafor. The background is that Dilafor’s drug candidate tafoxiparin has shown a significantly positive impact on cervix ripening in a recently conducted phase 2b study in first-time mothers receiving treatment to induce labor. The external valuation, which has been risk-adjusted by Karolinska Development, will preliminarily have a positive effect of approximately SEK 450 million on the booked fair value of the holding in Dilafor that is indirectly owned via KDev Investments AB. This has a positive impact on the net result in Karolinska Development AB in the second quarter of 2021 amounting to approximately SEK 250 million, corresponding to ca SEK 1.42 per share. About a quarter of all pregnant women are subject to labor induction, but more than half of these treatments fail. This leads to a prolonged birth process that increases the need for a caesarean section and the risk of complications in both mother and child. Dilafors' double-blind, placebo-controlled phase 2b study of the drug candidate tafoxiparin included 170 first-time mothers with unripe cervix, who received treatment to ripen the cervix and thereby facilitate the onset of labor. The study results showed that tafoxiparin had a positive effect on the ripening of the cervix compared with placebo, a difference that was highly statistically significant (p <0.009). Based on these positive results, Dilafor plans to prolong the phase 2b study in order to document the effects of tafoxiparin in two lower doses. Market analyses show that a drug that can induce cervical ripening has the potential to reach annual sales in excess of USD 1 billion in the US market alone. “The positive phase 2b results are increasing the opportunities to develop Dilafor’s drug candidate tafoxiparin as a new treatment that reduces the risk of complications in children and mothers caused by slow progress of labor. This tangible progress has a strong positive impact on the valuation of the company,” comments Karolinska Development's CEO, Viktor Drvota. Karolinska Development has interest in Dilafor, through KDev Investments AB, of 30.9% of the outstanding shares in Dilafor. For further information, please contact: Viktor Drvota, CEO, Karolinska Development AB Phone: +46 73 982 52 02, e-mail: viktor.drvota@karolinskadevelopment.com Johan Dighed, General Counsel and Deputy CEO, Karolinska Development ABPhone: +46 70 207 48 26, e-mail: johan.dighed@karolinskadevelopment.com TO THE EDITORS About Karolinska Development ABKarolinska Development AB (Nasdaq Stockholm: KDEV) is a Nordic life sciences investment company. The company focuses on identifying breakthrough medical innovations in the Nordic region that are developed by entrepreneurs and leadership teams. The Company invests in the creation and growth of companies that advance these assets into commercial products that are designed to make a difference to patients' lives while providing an attractive return on investment to shareholders. Karolinska Development has access to world-class medical innovations at the Karolinska Institutet and other leading universities and research institutes in the Nordic region. The Company aims to build companies around scientists who are leaders in their fields, supported by experienced management teams and advisers, and co-funded by specialist international investors, to provide the greatest chance of success. Karolinska Development has a portfolio of ten companies targeting opportunities in innovative treatment for life-threatening or serious debilitating diseases. The Company is led by an entrepreneurial team of investment professionals with a proven track record as company builders and with access to a strong global network. For more information, please visit . This information is information that Karolinska Development AB (publ) (Nasdaq Stockholm: KDEV) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of Viktor Drvota, at 19:15 CET on 17th of June, 2021. Attachment

01 Jun 2021

·www.globenewswire.com

Karolinska Development's portfolio company Dilafor presents

STOCKHOLM, SWEDEN 1 June 2021. Karolinska Development AB (Nasdaq Stockholm: KDEV) announces today that the portfolio company Dilafor has concluded a phase 2b study with its drug candidate tafoxiparin which showed a significant positive impact on cervical ripening in first-time mothers receiving treatment to induce labor. Further and full analysis of data will be done by the company. Market analyses show that a drug that can induce cervical ripening has the potential to reach annual sales in excess of USD 1 billion in the US market alone. Karolinska Development will obtain an external assessment of how the positive study results affect the book value of its holding in Dilafor. About a quarter of all pregnant women are subject to labor induction, however more than half of these experience failed induction. This leads to a prolonged birth process that increases the need for a caesarean section and the risk of complications in both mother and child. Dilafors' double-blind, placebo-controlled phase 2b study of the drug candidate tafoxiparin includes 170 first-time mothers with unripe cervix, who received treatment to ripen the cervix and thereby facilitate the onset of labor. The patients in the study were treated with either a subcutaneous injection of tafoxiparin or placebo once daily for up to one week before the planned labor induction. The primary objective of the study was to document the effect of tafoxiparin on cervical ripening measured as the degree of ripening according to an internationally established scale, the Bishop score. The study results showed that tafoxiparin had a positive effect on the ripening of the cervix compared with placebo, a difference that was highly statistically significant (p <0.009). Based on these positive results, Dilafor plannes to prolong the phase 2b study in order to document the effects of tafoxiparin in two lower doses. “The convincing effect of tafoxiparin shown in the phase 2b study increases the hope of being able to offer women a new treatment that reduces the risk of complications in both mother and child caused by slow progress of labor. The positive clinical results constitute an important milestone in Dilafor’s development as a company and open up great commercial opportunities for the drug candidate,” comments Karolinska Development's CEO, Viktor Drvota. Karolinska Development has interest in Dilafor through KDev Investments holdings of 30% of the outstanding shares in Dilafor. For further information, please contact: Viktor Drvota, CEO, Karolinska Development AB Phone: +46 73 982 52 02, e-mail: viktor.drvota@karolinskadevelopment.com Johan Dighed, General Counsel and Deputy CEO, Karolinska Development ABPhone: +46 70 207 48 26, e-mail: johan.dighed@karolinskadevelopment.com TO THE EDITORS About Karolinska Development ABKarolinska Development AB (Nasdaq Stockholm: KDEV) is a Nordic life sciences investment company. The company focuses on identifying breakthrough medical innovations in the Nordic region that are developed by entrepreneurs and leadership teams. The Company invests in the creation and growth of companies that advance these assets into commercial products that are designed to make a difference to patients' lives while providing an attractive return on investment to shareholders. Karolinska Development has access to world-class medical innovations at the Karolinska Institutet and other leading universities and research institutes in the Nordic region. The Company aims to build companies around scientists who are leaders in their fields, supported by experienced management teams and advisers, and co-funded by specialist international investors, to provide the greatest chance of success. Karolinska Development has a portfolio of ten companies targeting opportunities in innovative treatment for life-threatening or serious debilitating diseases. The Company is led by an entrepreneurial team of investment professionals with a proven track record as company builders and with access to a strong global network. For more information, please visit . This information is information that Karolinska Development AB (publ) (Nasdaq Stockholm: KDEV) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of Viktor Drvota, at 13:15 CET on 1 June, 2021. Attachment

100 Deals associated with Tafoxiparin

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Labor, Induced	Phase 2	FI	Dilafor AB	21 Jun 2019
Labor, Induced	Phase 2	SE	Dilafor AB	21 Jun 2019
Dystocia	Phase 2	-	Lee's Pharmaceutical (HK) Ltd.	-
Heart Arrest	Preclinical	DK	Dilafor AB	01 Dec 2016
Heart Arrest	Preclinical	FI	Dilafor AB	01 Dec 2016
Heart Arrest	Preclinical	SE	Dilafor AB	01 Dec 2016
Obstetric Labor, Premature	Preclinical	SE	Dilafor AB	01 Dec 2016
Obstetric Labor, Premature	Preclinical	FI	Dilafor AB	01 Dec 2016
Obstetric Labor, Premature	Preclinical	DK	Dilafor AB	01 Dec 2016
Pregnancy	Preclinical	SE	Dilafor AB	01 Apr 2007

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