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2016-12-12

Herantis Pharma Oyj: Herantis Pharma's Parkinson study wins EUR 6.0 million grant from the European Union Horizon 2020 program

Herantis Pharma's Parkinson study wins EUR 6.0 million grant from the European
Union Horizon 2020 program

Herantis Pharma Plc
Company release 12 Dec 2016 at 9:00 am

The research and innovation program of the European Union, Horizon 2020, has
awarded a grant of approximately €6.0 million for Herantis Pharma Plc's
("Herantis") Phase 1-2 clinical study with Herantis' drug candidate CDNF for
the treatment of Parkinson's disease ("PD"), using an innovative drug
administration device of Renishaw plc; and for supporting scientific
research. With the grant Herantis expects its financial position to remain
positive until the end of 2018 (previously estimated: End of 2017). The short
name of the Horizon 2020 project is TreatER.

The TreatER project will be executed by a consortium of 11 members including
Herantis as the formal sponsor of the clinical study and the owner of CNDF
patents, and the University of Helsinki where CDNF was discovered. The
consortium also includes three university hospitals responsible for patient
treatments: Karolinska University Hospital and Lund University Hospital in
Sweden, and Helsinki University Hospital in Finland; two pharmaceutical
companies with strong expertise in PD: Lundbeck and Orion Pharma; Karolinska
Institutet in Sweden as a leading expert in advanced PET imaging in PD; the
University of Oxford and Renishaw plc in the United Kingdom; and the European
Parkinson's Disease Association.

"This is a great achievement for our consortium and a significant reward for
years of hard work by the Herantis team", saysPekka Simula
, CEO of Herantis. "Horizon 2020 grants are very competitive and this award
required a strong European consortium, leading science, and highest potential
to advance clinical practice. Collaboration of the TreatER partners has
already been unique toward a common goal: Breakthrough in the treatment of
Parkinson's disease."

"Starting clinical studies is a great moment for a scientist. I am very
optimistic about our prospects because CDNF has been efficacious in a number
of disease models of Parkinson's disease", says professorMart Saarma
of the University of Helsinki. Professor Saarma's scientific research lead to
the discovery of CDNF and his research group continues to uncover its further
potential in the treatment of neurodegenerative diseases.

The EU grant enables extending the clinical study's CDNF treatment period to
12 months under two separate clinical protocols, and including advanced
endpoints such as actigraphy and innovative PET imaging, which are expected
to increase the impact of the study. The grant also provides funding for
important supportive scientific research at the University of Helsinki and
the University of Oxford. Herantis retains full commercial rights to CDNF.

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 25 380 246

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. Following a preclinical
development program, which has showed it as efficacious in several
preclinical models of Parkinson's disease, Herantis is preparing for a
first-in-human clinical study of CDNF in the treatment of PD and has a
preclinical development program for the treatment of ALS.

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 several 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 professorMart 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 and 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

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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

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