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Clinical Trials

Date: 2012-12-13

Type of information: Initiation of preclinical development

phase: 1

Announcement: results

Company: PDC Biotech (Austria)

Product: PDC31

Action mechanism:

PDC31 is a synthetic octapeptide which was designed to act as an allosteric modulator of the receptor for prostaglandin F2? (FP receptor). PDC31 exerts its effects at a site distinct from the binding site for PGF2?; the putative mechanism of action is that it interferes with certain interactions between specific FP receptor domains, thereby biasing PGF2?-mediated signaling via the G?q-PKC-MAPK pathway, while decreasing signaling through the G?12-Rho-ROCK pathway. The net effect of this altered signaling is the inhibition of contraction.

Disease:

preterm labour

Therapeutic area: Women health

Country:

Trial details:

Latest news:

PDC Biotech has successfully completed a phase I clinical trial for its lead compound for the treatment of preterm labour. This study was designed to evaluate safety as well as provide proof-of-concept for the ability of the compound to inhibit excessive uterine contractility. The study was conducted in healthy women with primary dysmenorrhea , a condition associated with painful, labour-like contractions which occur during menstruation. PDC31 infusion was associated with a dose-dependent relief of pain, as well as a reduction in intrauterine pressure. In addition, the drug was very well tolerated and there were no dose limiting toxicities. The results from this study support the continued development of PDC31 for both preterm labour and primary dysmenorrhea.

 

 

 

 

 

Is general: Yes