Herantis granted approval by Finnish Medicines Agency Fimea for its Parkinson's disease clinical trial.
M2 EQUITYBITES-June 12, 2017-Herantis granted approval by Finnish Medicines Agency Fimea for its Parkinson's disease clinical trial
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Finnish Medicines Agency Fimea has authorised Herantis Pharma plc's (HEL: HRTIS) first-in-human clinical study of its investigational product CDNF for the treatment of Parkinson's disease, the Finnish drug development company reported on Monday.
The news follows Herantis' announcement earlier this year that it had secured approval for the same clinical study in Sweden.
The first study site to begin patient recruitment will be the Karolinska University Hospital in Stockholm, Sweden, although the company has decided to postpone the launch of patient recruitment until the third quarter of 2017.
Herantis deemed this necessary due to the local holidays taking place that could otherwise disrupt the trials. Moreover, by waiting the company will be able to secure optimal resources as well as the safety of the patients.
The study is set to include 18 patients with Parkinson's disease. Of these, a subset will be given a placebo infusion instead of CDNF, in a blinded manner. Herantis hopes that this setup will deliver a strong initial assessment of the effects of CDNF.
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|Publication:||M2 EquityBites (EQB)|
|Date:||Jun 12, 2017|
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