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Siena Biotech

Siena Biotech is a privately held biotechnology company operating in the biomedical field of oncology and neurodenerative diseases, including rare diseases. The company was founded by its major shareholder Monte dei Paschi di Siena Foundation as operational company to perform in the field of pharmaceutical research and biotechnology.

Siena Biotech has secured top level management executives leading an established team of talented international scientists. Combining their drug discovery and development expertise with an integrated platform of cutting edge technologies housed in a purpose-built research centre, Siena Biotech developed a diversified pipeline of partnered, in licensed and proprietary products for oncology and neurodegenerative indications, including rare diseases.

Siena Biotech strategically collaborates with several Research Institutes and big multinational European pharmaceutical companies for many different projects. One of those is PADDINGTON, funded by the 7th Framework Programme of the European Community and dedicated to contribute to clinical studies to support the development of new drugs for rare diseases, such as the Huntington Disease (HD).

Siena Biotech therefore has involved five different European partners, with long experience in HD, in a consortium, sponsoring the first clinical trial for HD patients treated with selisistat (SEN0014196), a new drug under development by Siena Biotech SpA with the intent to use the compound to delay disability by either slowing progression of the disease or ultimately, and several other activities.

The consortium is composed by five partners from different European countries: Siena Biotech forItaly,UlmUniversityforGermany, University College of London UCL and 5.          LondonSchoolof Hygiene and Tropical Medicine (LSHTM) inUKand KCR inWarsaw,Poland.

 

The aim of the PADDINGTON project is to develop and apply a range of biomarkers that will help in the clinical development of a novel drug selisistat (SEN0014196, Siena Biotech) with disease-modifying potential in Huntington’s Disease.

PADDINGTON started in July 2011 and involves many clinical research sites inLondonand  Manchester(UK),Leiden(Netherlands), Paris (France),  UlmandBochum(Germany), Krakow (Poland) andWarsaw(Poland).

The PADDINGTON project includes six Work Packages, The first three of them are dedicated to a number of clinical, instrumental and bioanalytical activities; the fourth to statistical analyses, the fifth to project management and the sixth to dissemination and publication activities. The first three work packages are illustrated in the following.

Work package 1

Work package 1 is an exploratory phase IB clinical trial testing the safety and tolerability of the drug in a group of HD patients in the early and moderate phase of the disease.

60 volunteers with early and moderate Hd across 4 sites have been treated with selisistat once daily for two weeks. Participants are required to stay overnight in the Clinical Trial Centres at the beginning and end of the two week period. During this period, several tests have been executed to monitor the participants’ responses to the drug:

  • Blood samples withdrawal
  • Medical interview and neurological examination by a neurologist
  • Safety assessments, including physical examination
  • Behavioural and cognitive (thinking) tasks

Work package 2

Work package 2 is an imaging biomarker clinical study aiming at developing and getting in motion a feasible assessment package for tracking the progression of early stage Huntington’s disease.  This assessment package may provide a useful tool for future trials.  Work package 2 is an observational clinical study, not a drug trial.

However, it is hoped that, if found to be well tolerated and safe, the clinical trial with selisistat could be expanded into a Phase III trial using the framework developed in work package 2.

60 volunteers with early Huntington’s Disease and 40 control participants have been enrolled over 4 sites (London,Leiden,ParisandUlm). Assessments will last roughly 3 hours and will include:

  • An MRI scan (lasting approximately 45 minutes)
  • Two sets of blood withdrawal (the first being at fasting conditions before breakfast)
  • A medical interview and neurological examination by a neurologist
  • Cognitive (thinking) tasks

Work package 3

Work package 3 is dedicated to the development and validation of a number of bioanalytical techniques to measure potential biomarkers and their use to analyse the samples collected under work packages 1 and 2 clinical studies. These markers are developed both to support the development programme of selisistat and to be useful in future clinical trials testing new drugs efficacy in HD.