Ergomed plc FDA removal of hold on Ph3 trial with Multikine (9319N)
14 August 2017 - 9:31PM
UK Regulatory
TIDMERGO
RNS Number : 9319N
Ergomed plc
14 August 2017
PRESS RELEASE
Ergomed notes announcement by co-development partner, CEL-SCI,
of FDA removal of clinical hold on Phase 3 clinical trial with
Multikine in head and neck cancer
London, UK - 14 August 2017: Ergomed plc (LSE: ERGO) ('Ergomed'
or 'the Company'), a specialised pharmaceutical services and drug
development company, notes that its co-development partner CEL-SCI
has announced that the US Food and Drug Administration (FDA) has
removed the clinical hold on the current Phase 3 study with
Multikine in head and neck cancer.
All clinical trial activities can now be resumed. Nine-hundred
and twenty-eight (928) newly diagnosed head and neck cancer
patients have been enrolled in this Phase 3 study and all the
patients who have completed treatment continue to be followed for
protocol-specific outcomes in accordance with the Study
Protocol.
Dr. Dan Weng, Chief Executive Officer of Ergomed, said: "We're
very pleased to hear that the Phase 3 study of Multikine in head
and neck cancer has been approved for continuation by the FDA.
Multikine addresses a significant unmet medical need and we look
forward to continuing to work with CEL-SCI on what is the largest
ever Phase III study in head and neck cancer."
The full announcement from CEL-SCI can be found on its website:
www.cel-sci.com.
ENDS
Enquiries:
Ergomed plc Tel: +44 (0)
1483 503205
Dan Weng (Chief Executive Officer)
Stephen Stamp (Chief Financial
Officer)
Numis Securities Limited Tel: +44 (0)
20 7260 1000
Michael Meade / Freddie Barnfield
(Nominated Adviser)
James Black (Joint Broker)
N+1 Singer Tel: +44 (0)
20 7496 3000
Alex Price (Joint Broker)
Consilium Strategic Communications Tel: +44 (0)
- for UK enquiries 20 3709 5700
Chris Gardner / Mary-Jane ergomed@consilium-comms.com
Elliott
Ivar Milligan / Philippa Gardner
MC Services - for Continental Tel: +49 211
European enquiries 5292 5222
Anne Hennecke
About Ergomed
Ergomed provides specialist services to the pharmaceutical
industry and develops drugs both wholly-owned and through
partnerships. Ergomed's fast-growing, profitable service offering
spans all phases of clinical development and post-approval
pharmacovigilance and medical information. Drawing on more than 20
years of expertise in drug development, Ergomed is also building a
growing portfolio of drug development partnerships and programmes,
including wholly-owned proprietary products for the treatment of
surgical bleeding. For further information, visit:
http://ergomedplc.com.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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