EU/3/15/1595

Table of contents

About

On 14 December 2015, orphan designation (EU/3/15/1595) was granted by the European Commission to Coté Orphan Consulting UK Limited, United Kingdom, for live attenuated Listeria monocytogenes bioengineered with a chimeric human epidermal growth factor receptor 2 fused to a truncated form of the Lm protein listeriolysin O (also known as ADXS31-164) for the treatment of osteosarcoma.

The sponsorship was transferred to Quintiles Ireland Limited, Ireland, in March 2018.

In May 2018 the sponsor, Quintiles Ireland Limited changed name to IQVIA RDS Ireland Limited.

Key facts

Active substance
live attenuated Listeria monocytogenes bioengineered with a chimeric human epidermal growth factor receptor 2 fused to a truncated form of the Lm protein listeriolysin O
Disease / condition
Treatment of osteosarcoma
Date of decision
14/12/2015
Outcome
Positive
Orphan decision number
EU/3/15/1595

Sponsor's contact details

IQVIA RDS Ireland Limited
Estuary House
East Point Business Park
Fairview
Dublin 3
Ireland
Tel. +353 1819 5100

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe;
  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

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