CDNF news Herantis Pharma Plc completes patien
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Posted On: 02/01/2020 9:38:19 PM
CDNF news
Herantis Pharma Plc completes patient treatments in main study of Phase 1-2 CDNF trial in Parkinson’s disease
Herantis Pharma Plc
Company release 19 Dec 2019 at 4:00 pm
Herantis Pharma Plc (“Herantis” or “Company”) announced today having completed patient treatments as planned in the main study of the Company’s Phase 1-2 clinical trial examining Herantis’ proprietary neuroprotective factor and novel drug candidate CDNF in patients with Parkinson’s disease. Of the 17 patients randomized in the clinical trial, 15 patients completed the main study according to the study protocol and two patients discontinued due to reasons not related to CDNF. All 15 patients who completed the main study have decided to continue in the six-month extension protocol with continued monthly CDNF dosing.
“We are very grateful to the patients, the investigators, and the hospital staff of this clinical study,” commented Pekka Simula, CEO of Herantis. “We look forward to the excellently continuing collaboration in the ongoing extension study, as well as to the near-future read-outs from the main study.”
Herantis expects to announce initial data from the main study in the first quarter of 2020.
Study Design
The randomized, blinded, placebo-controlled Phase 1-2 trial is a first in human clinical trial that evaluates the safety and tolerability of CDNF, a novel experimental therapy, in patients with advanced Parkinson’s disease. In the main study, the patients received an implanted investigational drug delivery system and were randomized to receive either six monthly doses of placebo, or six increasing doses of CDNF. All patients who completed the main study decided to continue in the extension study, in which all patients are randomized to receive either higher or lower monthly CDNF doses for another six months. The extension study, which is expected to be completed latest in Q3/2020, is followed by a long-term follow-up study.
Study Objectives
The primary endpoints of the study will evaluate the safety and tolerability of CDNF as well as of the drug delivery device, and accuracy of surgical placement of the device in the study patients. The secondary and exploratory endpoints include initial signs of efficacy of CDNF treatment, e.g. Unified Parkinson’s Disease Rating Scale motor score evaluation, patient diary, dopamine transporter PET imaging, and the levels of different forms of alpha-synuclein in serum and cerebrospinal fluid.
Further information:
Herantis Pharma Plc, Pekka Simula, CEO, telephone: +358 40 7300 445
Company web site: www.herantis.com
Herantis Pharma Plc completes patient treatments in main study of Phase 1-2 CDNF trial in Parkinson’s disease
Herantis Pharma Plc
Company release 19 Dec 2019 at 4:00 pm
Herantis Pharma Plc (“Herantis” or “Company”) announced today having completed patient treatments as planned in the main study of the Company’s Phase 1-2 clinical trial examining Herantis’ proprietary neuroprotective factor and novel drug candidate CDNF in patients with Parkinson’s disease. Of the 17 patients randomized in the clinical trial, 15 patients completed the main study according to the study protocol and two patients discontinued due to reasons not related to CDNF. All 15 patients who completed the main study have decided to continue in the six-month extension protocol with continued monthly CDNF dosing.
“We are very grateful to the patients, the investigators, and the hospital staff of this clinical study,” commented Pekka Simula, CEO of Herantis. “We look forward to the excellently continuing collaboration in the ongoing extension study, as well as to the near-future read-outs from the main study.”
Herantis expects to announce initial data from the main study in the first quarter of 2020.
Study Design
The randomized, blinded, placebo-controlled Phase 1-2 trial is a first in human clinical trial that evaluates the safety and tolerability of CDNF, a novel experimental therapy, in patients with advanced Parkinson’s disease. In the main study, the patients received an implanted investigational drug delivery system and were randomized to receive either six monthly doses of placebo, or six increasing doses of CDNF. All patients who completed the main study decided to continue in the extension study, in which all patients are randomized to receive either higher or lower monthly CDNF doses for another six months. The extension study, which is expected to be completed latest in Q3/2020, is followed by a long-term follow-up study.
Study Objectives
The primary endpoints of the study will evaluate the safety and tolerability of CDNF as well as of the drug delivery device, and accuracy of surgical placement of the device in the study patients. The secondary and exploratory endpoints include initial signs of efficacy of CDNF treatment, e.g. Unified Parkinson’s Disease Rating Scale motor score evaluation, patient diary, dopamine transporter PET imaging, and the levels of different forms of alpha-synuclein in serum and cerebrospinal fluid.
Further information:
Herantis Pharma Plc, Pekka Simula, CEO, telephone: +358 40 7300 445
Company web site: www.herantis.com
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