ClinStorage, www.clinstorage.se is a proud delivery and service partner to the Karma project, www.karmastudien.se. The Karma Intervention Trial, Karisma, aims at identifying the optimal dose of an anti-hormonal drug substance that prevents breast cancer and comes with fewer side effects than the established dose.
The drug substance is used by breast cancer patients to lower the risk of a breast cancer recurrence. It has been shown that perfectly healthy women lower their risk of breast cancer by 50% if they use the drug substance. However, the drug substance is not used for prevention due to severe side effects.
It is not obvious that the same dose should be used for prevention as the dose given to breast cancer patients. In the trial are now therefore 4 lower doses of tamoxifen and placebo tested to investigate and compare the therapeutic effect with the clinically accepted 20 mg. The Principal Investigator, Prof. Per Hall, Karolinska Institute, and the Karma project group had problems to find a European Contract Manufacture Organisation (CMO) that could deliver the requested capability at a reasonable cost with regard to Chemistry, Manufacture and Control (CMC) aspects of the project. ClinStorage was then contacted regarding the CMC part of the project. Since ClinStorage is a small and lean organisation with a vast competence in CMC a good match was found. ClinStorage was contracted for management of the manufacturing (in 3rd country) of the 5 different strengths and placebo ascertain a process fulfilling the EU guideline for importation of investigational medicinal products (IMPs) to EU, QP release of the IMPs and providing the CMC regulatory dossier.
The Karmastudien was approved by the Swedish MPA and started last autumn and is now in the second phase of enrolment. We at ClinStorage do look forward to the read out at the completion of this important study.
For more info about the study see 13/2, 20.00, SVT2, Vetenskapens Värld