|
Phase IV post marketing study results for Totect(R) accepted by the FDA |
|
|
|
24 Jul 2008 |
|
TopoTarget announced that the Post Marketing ommitment to complete and submit a pharmacokinetic analysis for Totect(R) has been fulfilled and accepted by the FDA. During the approval process of Totect(R) (trade name Savene(R) in the European market)
Copenhagen, Denmark | July 24, 2008 | TopoTarget A/S (OMX: TOPO) announced that the Post Marketing ommitment to complete and submit a pharmacokinetic analysis for Totect(R) has been fulfilled and accepted by the FDA. During the approval process of Totect(R) (trade name Savene(R) in the European market).
TopoTarget made a commitment to complete and submit a postmarketing population pharmacokinetic analysis to the FDA. A clinical phase IV study was conducted to examine the pharmacokinetics of a 3-day dosing regimen of Totect(R) efficacy in patients suffering from anthracycline extravasation.
The clinical results confirmed TopoTarget’s theoretical model and thus ruled out Totect(R) accumulation during the recommended 3-day treatment regime. The results were accepted by the FDA and TopoTarget has now fulfilled its commitment.
Today’s news does not change TopoTarget’s full-year financial guidance for 2008.
About TopoTarget
TopoTarget (OMX: TOPO) is an international biotech company headquartered in Denmark, dedicated to finding ''Answers for Cancer'' and developing improved cancer therapies. The company is founded and run by clinical cancer specialists and combines years of hands-on clinical experience with in-depth understanding of the molecular mechanisms of cancer. Focus lies on highly predictive cancer models and key cancer targets (including HDACi, NAD+, mTOR, FasLigand and topoisomerase II inhibitors). TopoTarget has a broad cllinical pipeline with 9 products in development, including belinostat which has shown proof of concept as monotherapy in treating haematological malignancies and positive results in solid tumours where it can be used in combination with full doses of chemotherapy. The company's first marketed product Savene(R)/Totect(R) was approved by EMEA in 2006 and the FDA in 2007 and is marketed by TopoTarget’s own sales force in Europe and the US. For more information, please refer to www.topotarget.com.
SOURCE: TopoTarget A/S |
