Sign up UNITED KINGDOM
Proactive Investors - Run By Investors For Investors

Evgen Pharma shares jump after positive updates on two Phase II clinical trials for its SFX-01 treatment

Dr Stephen Franklin, Evgen Pharma’s CEO said: "We are very pleased that there have been no safety or tolerance issues reported to date on either of our two Phase II trials and we are delighted to have successfully initiated a second site for the SAS trial"
Cancer patient
In mid-morning trading, Evgen shares were up 11.7%, or 2.25p at 21.5p

Evgen Pharma PLC (LON:EVG) saw its shares jump almost 12% higher this morning after the drug development company reported positive updates on two Phase II clinical trials for its SFX-01 treatment with “no safety or tolerance issues reported to date”.

In a statement, the AIM-listed group said the first patient dosed in its STEM clinical study, testing SFX-01 in the treatment and evaluation of metastatic breast is now approaching week 24 – having been treated in January – and has demonstrated “no disease progression for three consecutive scans. “

On this basis, Evgen said it has initiated a “compassionate use programme”, so that patients can continue to receive SFX-01 after week 24.

It added that STEM will now recruit 60 patients from multiple sites in the UK and from sites in up to four other European countries. 

The firm added, due to protracted regulatory submissions in France, Spain and the Czech Republic, it is now projecting the final read-out from the STEM study in the second half of calendar year 2018.

Second SAS trial site initiated at Queen Elizabeth Hospital in Birmingham

In SAS, the other Phase II trial using SFX-01 for subarachnoid haemorrhage treatment, Evgen said that  to date 34 patients have been recruited at the Southampton site, with the first dosed in May 2016, and it will recruit a total of 90 patients. 

The group noted that, in its second meeting since the start of the SAS trial, the independent Data Safety Monitoring Board also confirmed there are no safety issues attributable to SFX-01.

The company also announced that a second SAS trial site has been initiated at Queen Elizabeth Hospital in Birmingham to accelerate patient recruitment.

Evgen said it  is anticipating read-out from the SAS study around the end of calendar year 2018.

Encouraged by requirement to initiate a compassionate use programme

Dr Stephen Franklin, Evgen Pharma’s CEO said: "We are very pleased that there have been no safety or tolerance issues reported to date on either of our two Phase II trials and we are delighted to have successfully initiated a second site for the SAS trial.

“In the STEM trial, we will provide the market with an interim data analysis in the first half of calendar year 2018 and we are encouraged by the requirement to initiate a compassionate use programme."

In mid-morning trading, Evgen shares were up 11.7%, or 2.25p at 21.5p.

In a note to clients, broker Northland Capital said: “Positive news for Evgen Pharma with the Company making significant progress, despite a minor delay, in both of its phase two trails.

“There have been no safety issues or tolerance issues for either of the Phase II trials to date and final read-outs from both the studies are expected next year, a major milestone for the Company.”

View full EVG profile View Profile

Evgen Pharma Timeline

Article
October 21 2015

Related Articles

Paradigm Biopharmaceuticals: Access latest PPT from Proactive's CEO Sessions
May 18 2017
Paul Rennie talked timeline to clinical trial results with investors.
generic pill and bottle shot to denote Alliance's products
August 14 2017
The company has made the transition from a business capitalised at £90mln to company now worth around a quarter of a billion pounds - but has the market at large picked up on (and priced in) the transformation?
blood cells
October 04 2017
The two parts of the business - the commercial arm and research function - appear to be firing on all cylinders

No investment advice

The Company is a publisher. You understand and agree that no content published on the Site constitutes a recommendation that any particular security, portfolio of securities, transaction, or investment strategy is suitable or advisable for any specific person. You further understand that none of the information providers or their affiliates will advise you personally concerning the nature, potential, advisability, value or suitability of any particular security, portfolio of securities, transaction, investment strategy, or other matter.

You understand that the Site may contain opinions from time to time with regard to securities mentioned in other products, including company related products, and that those opinions may be different from those obtained by using another product related to the Company. You understand and agree that contributors may write about securities in which they or their firms have a position, and that they may trade such securities for their own account. In cases where the position is held at the time of publication and such position is known to the Company, appropriate disclosure is made. However, you understand and agree that at the time of any transaction that you make, one or more contributors may have a position in the securities written about. You understand that price and other data is supplied by sources believed to be reliable, that the calculations herein are made using such data, and that neither such data nor such calculations are guaranteed by these sources, the Company, the information providers or any other person or entity, and may not be complete or accurate.

From time to time, reference may be made in our marketing materials to prior articles and opinions we have published. These references may be selective, may reference only a portion of an article or recommendation, and are likely not to be current. As markets change continuously, previously published information and data may not be current and should not be relied upon.

© Proactive Investors 2017

Proactive Investor UK Limited, trading as “Proactiveinvestors United Kingdom”, is Authorised and regulated by the Financial Conduct Authority.
Registered in England with Company Registration number 05639690. Group VAT registration number 872070825 FCA Registration number 559082. You can contact us here.

Market Indices, Commodities and Regulatory News Headlines copyright © Morningstar. Data delayed 15 minutes unless otherwise indicated. Terms of use