PDC Biotech GmbH Announces Successful Clinical Phase I for Its Lead Compound PDC31

Vienna, Austria, December 13, 2012 / B3C newswire / - PDC Biotech GmbH (PDC) today announced that it 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. Dr. Roman Götz, Managing Director of the company said: “We are pleased with the encouraging results of this study, which now enable us to move forward into further development for the preterm labour indication.”
Dr. Ernest Loumaye (Chairman of the Board) said: ”The first administration in human study is an important step toward the development of this first in class compound, as the compound is well tolerated and pharmacodynamic results provide preliminary evidence in man of the validity of the target for the selected indications.”

About PDC31
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.
Preterm Labour
Preterm labour is defined as regular uterine contractions associated with cervical changes occurring before 37 weeks of gestation. Preterm birth, which is associated with increased risk of neonatal morbidity and mortality, is most often preceded by preterm labour. Preterm birth rates, currently 8 to 12 % of all births, are rising worldwide. Preterm birth is the leading cause of neonatal death and is associated with an increased risk of neonatal morbidity as well as longer term development deficits.
Primary Dysmenorrhea
Primary dysmenorrhea is a disabling condition found in women of childbearing age with a high prevalence among adolescent females. Severe abdominal pain is caused by frequent and prolonged uterine contractions that decrease blood flow to the myometrium resulting in ischemia.
About PDC Biotech GmbH
PDC Biotech GmbH (PDC) is an Austrian biotechnology company focused on women's health. PDC is a developing novel compound which targets the prostaglandin F2a receptor for the treatment of preterm labour and primary dysmenorrhea. PDC has licensed exclusive worldwide rights to a family of FP receptor antagonists from Theratechnologies Inc. (www.theratech.com). The company’s development efforts have been significantly supported by its lead investors MIG (www.mig.ag ) and Edmond de Rothschild Investment Partners (www.edrip.fr ) as well as by the AWS (Austrian public funds) and the ZIT (public funds of the City of Vienna).

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