FDA removal of hold on Ph3 trial with Multikine

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: [phone]
Dan Weng (Chief Executive Officer)
Stephen Stamp (Chief Financial Officer)
Numis Securities Limited		Tel: [phone]
Michael Meade / Freddie Barnfield (Nominated Adviser)
James Black (Joint Broker)
N+1 Singer		Tel: [phone]
Alex Price (Joint Broker)
Consilium Strategic Communications - for UK enquiries		Tel: [phone]
Chris Gardner / Mary-Jane Elliott Ivar Milligan / Philippa Gardner	[e-mail]
MC Services - for Continental European enquiries		Tel: [phone]
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.

 

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