SFX-01 meets primary endpoints in STEM trial

RNS Number : 8076T

Evgen Pharma PLC

25 March 2019

 

For immediate release

25 March 2019

 

 

Evgen Pharma plc

("Evgen" or "the Company")

SFX-01 meets primary endpoints in Phase II STEM trial

for the treatment of metastatic breast cancer

Evgen Pharma (AIM: EVG), a clinical stage drug development company focused on the treatment of cancer and neurological conditions, today announces positive headline results from the open-label Phase II trial of SFX-01 in 46 patients with estrogen-positive (ER+) metastatic breast cancer. 

Highlights

·    Conclusive evidence of anti-cancer activity via objective responses (tumour shrinkage)

·    24% of patients show a durable clinical benefit for at least 6 months, despite the late stage of disease and patients' established resistance to hormone therapy

·    Mild and favourable side effect profile for an anti-cancer drug

·    Further development of SFX-01 planned for earlier stage patients as an adjunct to a second line hormone therapy to delay onset of resistance

The STEM trial's Chief Investigator, Dr Sacha Howell of the Christie Hospital, will discuss the headline results today at 9am GMT via a live webcast and simultaneous conference call. Further details are set out below.

The STEM trial is the first study of SFX-01 in cancer patients and had the objectives of evaluating the safety and tolerability of SFX-01 in combination with an aromatase inhibitor (AI) or tamoxifen or fulvestrant; and of determining the clinical benefit rate ("CBR") at 24 weeks.

With regards to safety and tolerability, the primary endpoint was the number and severity of treatment-emergent adverse events (side effects). As expected, SFX-01 had a favourable side effect profile, particularly when compared with other drugs used in cancer therapy. The main side effects were mild (Grade 1) gastrointestinal symptoms, including nausea and reflux. 

With regards to efficacy, the primary endpoint was CBR at 24 weeks - the percentage of patients that had an objective response (tumour shrinkage by at least 30%) or stable disease for at least 24 weeks. CBR is a standard tool for assessing drug activity in breast cancer clinical trials.  This is a demanding endpoint for patients that have disease progression (tumour growth) on their final hormone treatment, and to which SFX-01 was added in the STEM trial. The CBR was 24%, an improvement on the Interim read-out on 11 June 2018, and included two patients with an objective response, representing  conclusive evidence of anti-cancer activity.

The corporate objective is now to move SFX-01 into a randomised, double-blind, clinical trial in patients who are earlier in their treatment pathway and have been treated with only one prior therapy for metastatic disease. Adding SFX-01 with a newly prescribed hormone therapy is likely to extend significantly its utility before resistance is acquired, whilst maintaining a favourable side-effect profile so that quality of life is not compromised.

Dr Sacha Howell, STEM Chief Investigator, Christie Hospital, Manchester, UK, said:

"We are very excited by the STEM trial results. This level of disease stabilisation, coupled with objective evidence of tumour shrinkage, bodes well for testing SFX-01 earlier in the treatment path. It would not be unreasonable to expect to see even greater efficacy when SFX-01 is given alongside a hormone therapy to which the cancer is naïve, with the intention of delaying the onset of hormone resistance.

"The clinical need associated with improving the durability of response to hormone therapies is evidenced by the recent commercial success of the CDK4/6 inhibitors. However, metastatic breast cancer remains incurable and despite the initial success with these drugs all cancers will progress and patients require additional active therapies. If clinical development continues positively, we can foresee SFX-01 being used with second line hormone therapy after CDK4/6 inhibitors' failure. The excellent tolerability of SFX-01 makes this a very attractive proposition."

Dr Stephen Franklin, CEO, Evgen Pharma, said: 

"We are absolutely delighted with the trial result and it has galvanised our enthusiasm and commitment to ensure SFX-01 continues its development in breast and other cancers.  In the context of this particular patient group, the clinical benefit observed is very encouraging and we have a high level of confidence that it will perform even better when used to delay the resistance to a newly presented second-line hormone therapy.

"Apart from meeting the primary endpoints, we can also report that of the 46 patients in the trial, 13 registered for the compassionate use programme enabling access to the drug after completion of the study and the longest period for which a patient derived clinical benefit was an outstanding 448 days.

"We now look forward to submitting the data to the 2019 ESMO Congress in Barcelona, a key event in terms of disseminating the results to the clinical community and supporting our ongoing business development activity."

Webcast and conference call

The headline results of the STEM trial will be discussed at 9am GMT today via a live webcast, accessible at:  http://webcasting.buchanan.uk.com/broadcast/5c6ed00fe6e1d92d38f4f915.

A simultaneous conference call will be provided for analysts and institutional investors only, including a facility to ask questions. Dial-in number: + 44 (0) 333 3000 804; PIN 49322076#.

Private shareholders with questions should email them to [e-mail] during or after the webcast; the questions will be collated for inclusion in the webcast.

A recording of the webcast will be available later today in the Shareholder Information section of the Company's website, www.evgen.com.

The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014 ("MAR"). Upon publication of this announcement, this inside information is considered to be in the public domain.

Enquiries:

Evgen Pharma plc Dr Stephen Franklin, CEO Richard Moulson, CFO www.evgen.com	c/o [phone]
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 Pharma 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®, 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. 

The Group 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

 

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