Herantis Pharmas clinical study with CDNF in Parkinsons disease authorized in Sweden
(Thomson Reuters ONE) -
Herantis Pharma's clinical study with CDNF in Parkinson's disease authorized in
Sweden
Herantis Pharma Plc
Company release 23 March 2017 at 12:30 pm
The Medicines Agency of Sweden, MPA, has authorized Herantis Pharma Plc's
("Herantis") first-in-human clinical study of the company's investigational
product CDNF for the treatment of Parkinson's disease. Patient recruitment in
the randomized, placebo-controlled Phase 1-2 clinical study is planned to begin
in Sweden in the first half of 2017.
"CDNF is a novel neurotrophic and neuroprotective factor, which affects several
mechanisms relevant to Parkinson's disease", explains Sigrid Booms, Herantis'
Director, Clinical Development. "Based on preclinical data CDNF holds a great
promise for a significant improvement over currently available treatments. We
are really excited to proceed to this first clinical study."
"Parkinson's disease is a tremendous financial burden to societies in addition
to the human suffering", says Pekka Simula, CEO of Herantis. "Known drugs only
alleviate motor symptoms until further disease progression. Our ambition is to
slow down, stop, hopefully even reverse the progression of the disease. CDNF is
a promising novel drug candidate, which works via several relevant biological
mechanisms that also clearly differentiate it from conventional neurotrophic
factors. This regulatory approval marks a very important milestone in our
development."
The first study site to start patient recruitment will be Karolinska University
Hospital in Stockholm, Sweden. Two other university hospitals are planned to
join the study later in 2017. The clinical study intends to recruit in total
18 patients with Parkinson's disease.
Further information:
Herantis Pharma Plc, Pekka Simula, CEO, telephone: +358 40 7300 445
Company web site: www.herantis.com
Certified Advisor: UB Securities Ltd, telephone: +358 9 25 380 225
About Parkinson's disease
Parkinson's disease is a slowly progressing neurodegenerative disease caused by
the death of dopaminergic neurons in the midbrains. Common first motor symptoms
of the disease include tremors, rigidity and slowness of movement. While the
motor symptoms can be treated with medication the disease progression cannot be
prevented, and the benefits of medication may be lost with disease progression
or side effects can become unmanageable. In addition, Parkinson's disease may
cause non-motor symptoms such as sleep problems, depression, and anxiety, which
are not alleviated by current Parkinson's drugs. Estimated 7 million people
worldwide have Parkinson's disease.
About CDNF
CDNF, or Cerebral Dopamine Neurotrophic Factor, is an endoplasmic reticulum
located and secreted protein with neuroprotective and neurorestorative
properties, patented worldwide by Herantis. Encouraged by strong preclinical
proof-of-concept Herantis is launching a first-in-human, randomized Phase 1-2
clinical study with CDNF for the treatment of Parkinson's disease (PD) in
1H/2017. The clinical study has received funding from the European Union's
Horizon 2020 research and innovation program under grant agreement number
732386.
In preclinical studies including chronic toxicology studies, CDNF administration
has been safe; CDNF has protected and regenerated midbrain dopamine-generating
cells suggesting a potential for disease modification of PD; it has also shown
efficacy in non-motor symptoms in PD. In an ALS disease model CDNF has
significantly increased survival and reduced symptoms. This suggests the
potential to address unmet clinical needs in both PD and ALS. CDNF is based on
research at the Institute of Biotechnology at the University of Helsinki, lead
by professor Mart Saarma.
About drug development in general
Drug development projects can usually be divided in two stages: The preclinical
stage, and the clinical stage involving human subjects. The clinical stage can
be further broken in three formal phases. Phase 1 clinical studies assess the
safety of a drug candidate in human subjects. In Phase 2, the optimal dosing and
possible efficacy in the treatment of a particular disease is studied. Phase 3
studies finally aim to establish a statistical proof of safety and efficacy of
the drug candidate in typically hundreds or thousands of patients for market
approval. Drug development can take 10-15 years from the first preclinical
studies to market approval.
About Herantis Pharma Plc
Herantis Pharma Plc is an innovative drug development company focused on
regenerative medicine for breakthrough in unmet clinical needs. Our first-in-
class assets are based on globally leading scientific research in their fields:
CDNF for disease modification in neurodegenerative diseases, primarily
Parkinson's and ALS; and Lymfactin for breast cancer associated lymphedema, with
potential also in other lymphedemas. The shares of Herantis are listed on the
First North Finland marketplace run by Nasdaq Helsinki stock exchange.
Distribution:
Nasdaq Helsinki
Main media
www.herantis.com
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Herantis Pharma Oyj via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 23.03.2017 - 11:30 Uhr
Sprache: Deutsch
News-ID 532015
Anzahl Zeichen: 6143
contact information:
Town:
Helsinki
Kategorie:
Business News
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