Evgen Pharma PLC Clinical trial update confirms read-outs on track (0442P)

TIDMEVG

RNS Number : 0442P

Evgen Pharma PLC

05 February 2019

 
 For immediate release    5 February 2019 
 

Evgen Pharma plc

("Evgen" or "the Company")

Clinical trial update confirms read-outs on track

Last patient recruited to SAS Phase II trial and last patient completes STEM Phase IIa trial

Evgen Pharma plc (AIM: EVG), a clinical stage drug development company focused on the treatment of cancer and neurological conditions, is pleased to announce the following clinical trial update.

SAS Phase II trial

Patient recruitment has completed in the SAS Phase II trial of SFX-01 in subarachnoid haemorrhage. As patients are dosed for a maximum of 28 days, the Company anticipates, in-line with market expectation, the read-out of the primary endpoints of the trial in Q2 calendar year 2019.

The SAS trial is a randomised, double blind, placebo-controlled trial which has now recruited 90 patients. The primary endpoints of SAS relate to safety, tolerability and blood flow as measured by Transcranial Doppler ("TCD") ultrasound. TCD provides a rapid, non-invasive, real-time measurement of blood flow in the basal arteries of the brain thereby detecting the Delayed Cerebral Ischaemia that affects a significant proportion of patients in the days following the initial haemorrhage.

The important secondary endpoints, which include the assessment of patients' cognitive function at three and six months post haemorrhage, will read-out in late summer 2019.

STEM Phase IIa trial

The Company is also pleased to announce that the last patient recruited to the STEM trial of SFX-01 in metastatic breast cancer has now completed her last visit in the trial, having reached the 24-week end-point without disease progression. She has now entered the compassionate use programme.

The STEM trial is an open label, multi-centre, Phase IIa trial of patients with ER+ metastatic breast cancer who had been on treatment with tamoxifen, aromatase inhibitors or fulvestrant. All patients had previously responded to their hormone therapy but then presented with progressive disease, demonstrating the start of resistance. The primary endpoints of the trial are safety, tolerability and clinical benefit rate as measured by RECIST (Response Evaluation Criteria in Solid Tumours).

An encouraging interim review of the STEM trial data was announced on 11 June 2018 and the Company continues to expect the final data read-out in the latter part of Q1 2019.

Dr Stephen Franklin, CEO of Evgen, commented:

"The recruitment phase of SAS is completed and we would like to take this opportunity to thank the clinical centres that helped achieve this milestone. Furthermore, with the completion of the treatment phase of STEM we would like to thank the clinicians and nurses at all the hospitals that participated in this European study. We look forward to the read-outs of the STEM and SAS trials and expect this to be a transformative year for the Company."

Enquiries:

 
 Evgen Pharma plc                                c/o [phone] 
  Dr Stephen Franklin, CEO 
  Richard Moulson, CFO 
  www.evgen.com 
 finnCap 
  Geoff Nash, Teddy Whiley (Corporate 
  Finance) 
  Alice Lane, Manasa Patil (ECM) 
  www.finncap.com                                    [phone] 
 WG Partners LLP 
  Nigel Barnes, Claes Spång                     [phone] 
 Buchanan 
  Mark Court, Sophie Wills, Tilly 
  Abraham 
  [e-mail]                              [phone] 
 

Notes for editors:

About Evgen Pharma plc

Evgen is a clinical stage drug development company whose lead programmes are in breast cancer and subarachnoid haemorrhage, a type of stroke. The Company's core technology is Sulforadex(R), a method for synthesising and stabilising the naturally occurring compound sulforaphane and novel proprietary analogues based on sulforaphane. The lead product, SFX-01, is a patented composition of synthetic sulforaphane and alpha-cyclodextrin.

Evgen commenced operations in January 2008 and has its headquarters at The Colony, Wilmslow, Cheshire, and its registered office is at the Liverpool Science Park, Liverpool. It joined the AIM market of the London Stock Exchange in October 2015 and trades under the ticker symbol EVG.

For further information, please visit: www.evgen.com

For commissioned research on the Company, please visit: http://evgen.com/investors/analyst-coverage/

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February 05, 2019 02:00 ET (07:00 GMT)