Ergomed plc FDA removal of hold on Ph3 trial with Multikine (9319N)

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              [e-mail] 
  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

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August 14, 2017 07:31 ET (11:31 GMT)