Evgen Pharma Share Discussion Threads

[l0ngterm] 20/11/2018 12:16

Not sure if this has been published/shared but found it on line. Significant drop in the mortality rate to 9.5% , for SAH.. apologies if this has already been shared.WM1-2SFX-01 after subarachnoid haemorrhage: protocol of a multi-centre, phase II, double- blinded, randomised controlled trialA. Zolnourian1, P. Holton1, I. Galea21University Hospital Southampton, Southampton, UK, 2University of Southampton, Southampton, UKObjectives. To assess the safety and efficacy of SFX-01 after subarachnoid haemorrhage.Design. SFX-01 is a synthetic agent that contains sulforaphane that has been shown to be neuroprotective in animal models of subarachnoid haemorrhage. This is a phase II double-bilinded, placebo-controlled randomised clinical trial.Subjects. Target of 90 patients with fisher 3 or 4 subarachnoid haemorrhageMethods. Patients admitted to the three recruiting centres within 48 hours of ictus will be randomly allocated to placebo or SFX-01. The randomisation is stratified into WFNS 1-3 or 4-5. Participants will receive the trial medication in a capsule format twice-daily for 28 days. Patients will have transcranial dopplers (TCD) on alternate daily basis for at least 7 days. The maximum mean MCA flow velocity as well as safety are the two primary end-points. All patients will have paired blood and CSF taken at day 7 either through an LP or via EVD sampling. Follow-ups are performed at day 28, 3 months and 6 months which include safety bloods, functional questionnaires, mRS, GOSE and MRI.Results. 64(71% of the target) patients have been enrolled. 35 patients have completed the study. Statistical analysis of the TCD data will be performed at the end of the trial. The mortality is at 9.5% (6). DSMB have met twice since the start of the trial and there have been no safety concerns.Conclusions. The trial is recruiting on the planned trajectory and at this rate we are projected to complete the trial by the end of the year.https://www.theabn.org/media/Documents/Annual%20Meetings/Wednesday%2019%20September%202018.pdf

[nico115] 20/11/2018 11:21

Just no stock around What price this going to ?30p like last couple of times or further as these results are more defining ?

[nobbygnome] 20/11/2018 11:04

Someone was prepared to pay 20p when the offer was 19p....Says a lot!

[nico115] 20/11/2018 10:31

I'm a buyer but at 17.5 so must be other buyers around Got a decent position

[nobbygnome] 20/11/2018 10:02

Wow. The MMs really are sensitive here to any buys. I suspect there must be a big buyer in the background. Nico, is it you?

Nobby

[l0ngterm] 19/11/2018 20:28

Thanks guys, just looking at the SAH trial from a different perspective. If the company have reduced the mortality rate from 50% considerable downwards, then hopefully this bodes well for the End points. GLA..

[timbo003] 19/11/2018 19:08

Regarding the SAH trial design, it worth revisiting Sally's slides from the September investor symposium

Note that nimodipine (i.e. SOC) is in both arms of the study and that the primary end points are blood flow and PK (not mortality or cognitive function)




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[timbo003] 19/11/2018 18:18

Probably the best (free access) review on nimodipine is this one:



I have given it a quick scan and it seems to suggest that the clinical evidence is not overwhelming, I will read it properly this evening.



.

[nobbygnome] 19/11/2018 17:34

From memory of the presentations I have attended the efficacy of nimodipine is marginal....but is the only treatment available for these patients.

[l0ngterm] 19/11/2018 17:08

So does anybody know the impact nimodipine, stand alone has on the mortality rate, or the results of any previous nimodipine trials?

[nobbygnome] 19/11/2018 16:38

I am correct. Extract from EVG website pasted below

Evgen Pharma’s clinical plans in neurology have started with a Phase II trial (named SAS) in patients that have had a type of stroke called a subarachnoid haemorrhage and will be led by principal investigator Diederik Bulters at University Hospital Southampton, UK. The objective of SFX-01 therapy (co-administered with standard-of-care nimodipine) is to reduce the vasospasm and incidence of delayed cerebral ischemia (which can lead to cognitive impairment) in the days following the haemorrhage. This trial, which has been statistically powered to underpin a potential conditional market approval, represents a potentially faster route to early licence revenue.

[nobbygnome] 19/11/2018 16:29

I am pretty sure that it was being compared with an active comparator called nimodipine but that is not what clinicaltrials.gov says. I would be very surprised if the placebo patients were not getting SOC! Timbo?

[l0ngterm] 19/11/2018 13:57

Was it not a 9% mortality rate with SFX-01 in combination with another drug? If so does anyone know if that is positive? I know sah has a mortality rate of 50% plus, but not sure about the combination drug?Any thoughts Nobby?

[nobbygnome] 19/11/2018 07:01

Yes I have always said the SAH trial is very difficult to call. The point is the mode of action in the 2 diseases is different so failure in one does not mean failure in the other is inevitable (and vice versa).

[l0ngterm] 19/11/2018 00:32

The SAH trial is double blinded, so possible could go the other way. A positive update on SAH recruitment, firming up the trial deadline may push this higher. The SAH trials has been running for 2 years, so assuming no safety or tolerability issues have been identified. But time will tell

[nobbygnome] 18/11/2018 17:25

I think the interest (and therefore also the volume) is bound to increase ahead of the well flagged trial results. We probably have less than 2 months to wait for both sets of results.

Actually just a thought, it will be a very interesting situation if the SAH results come out first and are negative. The breast cancer results would be still to come and very likely to be positive. There may be a bargain to be had on a lemmings pullback in such an event....

[l0ngterm] 16/11/2018 17:54

Sorry is the volume increasing daily or is it just me?

[nobbygnome] 15/11/2018 12:34

>> nico

Sadly the money won’t be in the account until next Thursday. Of course I could buy outside the SIPP but as we have discussed before one of my major goals is not to pay any CGT. Hence spreadbets and SIPPs are my modus operandi!

[nico115] 15/11/2018 11:05

I'm a buyer at 16p and won't spoil your order NobbyRisk reward still good here and i expect more interest on Nov 20th as we present at a conference so don't wait till then!!

[nobbygnome] 15/11/2018 10:31

Just hope the price stays low for another week or so. Then I will have the money from the Tyratech take over in my SIPP account and will be able to do some serious damage here!

[aoifesweb] 13/11/2018 17:39

Just doing a bit of maths here if Evgen can reeach say 20% of that $6billion market for breast cancer which it should do easily if approved, so that’s $1.2 billion in sales on a conservative 30% royalty that’s $400 million net to Evgen. Knock of say $20 million for r and d and admin expenses. So on a very conservative p/e of 10 we will have a market cap of $3.8 billion. Works out at around £29.50 per share. Granted it will take a few years to reach there, but all these numbers are very conservative could easily hit £100 if the percentage of the market reached increases or the p/e then just think if we are approved for other indications!

[l0ngterm] 13/11/2018 12:15

I think the supporting updates provided by the company, are the key with the trial meeting its end points early etc. The financials rewards are the end goal, but these updates provided the confidence for going forward. Extract below for any new investors. AIMHO.. From the AGM update in July:"We have already announced highly encouraging data from the metastatic breast cancer trial in an interim update in June 2018, which revealed SFX-01's signs of anti-tumour activity in a patient group where other treatment options had failed""Furthermore, yesterday we announced that the main aims of the metastatic breast cancer trial had been achieved, namely a favourable safety profile and evidence of clinical benefit, and that recruitment into the trial had been concluded at 50 patients rather than the total of 60 allowed under the trial protocol. We await the final details of the read-out of the trial with excitement, and see the likely next step for SFX-01 in metastatic breast cancer as a placebo-controlled trial with SFX-01 in combination with second-line hormone therapy in patients who have failed on CDK4/6 inhibitors."Statement a day or so before, trial update:"Dr Sacha Howell, Principal Investigator and Senior Lecturer and Honorary Consultant in Medical Oncology at the Christie NHS Foundation Trust, said:"The STEM trial is an exploratory trial that was designed to demonstrate safety and tolerability with long-term exposure to SFX-01 and to provide evidence that it has anti-tumour activity after failure of at least one and up to three prior hormone therapies. With these objectives in mind, we have sufficient evidence to believe that SFX-01 warrants further investigation through the conduct of a randomised placebo-controlled trial."

[aoifesweb] 13/11/2018 10:52

This is my favourite bit ‘Analysts at Northland Capital currently have a price target of 113p on the shares, providing over 500% upside from today’s share price. The global market opportunity in metastatic breast cancer alone for SFX-01 is estimated to be between US$6 to US$7bn/year, with this in mind it’s easy to see why analysts expect the shares perform so well.‘:

[apfindley] 13/11/2018 08:26

Good movement on low trading. Imagine how rapidly it will. I've in positive news, and on heavier buying. That 100p+ they slapped on it might be easily attainable.

[l0ngterm] 12/11/2018 21:17

Yeah, this could be higher especially with the cancer trials already meeting the end point. With a small amount of sellers/free float it will be interesting to see if the mms stick with the usual drop the price to find sellers, or twist and raise.. gla