Australian (ASX) Stock Market Forum

SRX - Sirtex Medical

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craft said:
Is it obvious? As I said its beyond my grasp yet to understand. Its not black and white that its just bad trial design that has caused the failure of the primary end point- the cohort selected, clinical outcomes expected and the sample size all interplay to hopefully avoid false results.

There is huge academic debate over clinical trial design and appropriate primary end points argued by much smarter people than me. Until there was a contradiction in primary and secondary outcomes I never delved into it - wish I had.

The trial design is a convenient explanation for the seeming contradiction of the two outcomes in the announcement. Another possibility is that OPFS has achieved clinical improvements but failed to do so with enough statistical confidence Until we have the data we don't know.
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were the patients who had liver + others mets treated with Spheres only or spheres + chemo? ethically you couldn't deny an effective treatment to experiment with another so you would do standard + test compared to standard only and look for a difference. I don't think they were looking to treat extra-liver mets with spheres at all, more looking to supplement the chemo with the liver targeted therapy.
 
omac said:
were the patients who had liver + others mets treated with Spheres only or spheres + chemo? ethically you couldn't deny an effective treatment to experiment with another so you would do standard + test compared to standard only and look for a difference. I don't think they were looking to treat extra-liver mets with spheres at all, more looking to supplement the chemo with the liver targeted therapy.
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The control arm was FOLFOX ( ± bevacizumab) which is current first line treatment. The trial arm was exactly the same thing but with the addition of SIR-Speres.

SIR-Spheres are only directed at Liver Mets. Up to 40% of patients recruited to the trial may have had other small tumours in other parts of their bodies - Not being fully across clinical trial design – and given the contradictory outcomes of primary and secondary outcomes . It does seem there’s a mismatch between SIR-Spheres application, Overall progression free survival as the primary end point, and recruiting patients with other tumours. But I know enough to know there is more to the story then just somebody making a nieve mistake in trial design. There are so many competing factors in trial design and whilst some compromises may have been made the sample size given the clinical expectations in relation to the primary end point should of been set for probable success. Failing the primary end point has been a big deal to the market – to me it’s not that important because of the PFS result in the liver and that data will assist the FOX FIRE studie’s primary end point of overall survival in mCRC – the real money shot.

That’s it for me for a while.

Cheers
 
Good points craft.

Medically, I would have thought rectal cancer would have to be quite advanced to start using the Sirtex treatment as if it was minor they would remove the tumour by operation. Since it is late stage and metastatic i.e. it has spread through the body, I can't see how it could possibly make any difference. I don't even know why they did it.

With liver disease you are trying to keep the liver going as this is what will kill you. The fact there are other cancers throughout the body which would be expected to be smaller and generally less important and their cancer load would be initially less though increasing. in this case if the treatment works then life should be extended.

I was affected due to my holding of HHV Hunter Hall Global who have a large interest in Sirtex. Though the news could have been better. The complexities of such a treatment and testing would make me want to see where the smart money is going rather than the flash crash guys. The improving SP suggests that we should not be overly concerned.
 
This has been a very informative thread. I thought Tuesday was an overreaction and it appears that that is the consensus.

craft said:
But I know enough to know there is more to the story then just somebody making a nieve mistake in trial design.
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Yes. I think waiting for May will bring much more light.
 
McLovin said:
This has been a very informative thread. I thought Tuesday was an overreaction and it appears that that is the consensus.
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I don't know... it feels like the consensus is too consistent. All the arguments I hear and read are very valid and reasonable... but they could all have been made PRIOR to the test results. Yet I have not read any analyst who gave the heads up BEFORE the announcement.

Anyhow... it's been very good trading SRX. I trade many stocks through an average day, but I think I was literally dedicated to SRX for much of Monday.

And FWIW, the share price now is basically the same as it was in Oct last year. The only news since then (other than the test announcement) was growth in dose sale (which was expected). You could argue that the trial result was not that bad, and the current price simply reflects the stock's value like it had been valued a mere 6 months ago. The announcement simply took the last $20 of bull run out of it.

It reminds me of MMS. Everything is sort of the same, but the share price isn't going back to where it was in a hurry.
 
Hurried back up a fair bit this morn... Up 36% although I do not completely understand why from the announcement
 
Huskar said:
Hurried back up a fair bit this morn... Up 36% although I do not completely understand why from the announcement
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8 Months progression free survival in the liver - with a very small statistical P value.

Its the progression in the liver that generally kills you.

Better than I expected - I thought it may come out around 5-6 Months.
 
Looked pretty good to me. Eight months PFS in the liver. The mCRC in the liver has the highest mortality of all mCRC by a long way. p-Value very good too.

ETA: I see craft beat me to it.
 
Was this announcement out of the blue or was there some way of knowing when it was coming?

I thought there would be no updates until late May.
 
skc said:
The abstract result clearly showed that the contents were market sensitive... and obviously SRX knew about its content before the abstract release.

Question:

Why does the ASCO meeting guidelines / rules trumpt the ASX disclosure rule?
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Good question and it’s not just the ASX they also seem to trump the SEC disclosure rules.

Medical profession has power in the right places I guess.

The initial release is the token gesture to appease the ASX disclosure rules but the partial information really just clouded the issue and created lots of volatility – this is the start of the real information flow.
 
In trading halt today ahead of the presentation in North America. Any thoughts on whether this is just "good practice" by the company or a sign of something different?
 
We have more data now and plenty of detail to come. Still plenty of confusion out there with analyst price targets ranging from $13.42 to $38.45. But there is a bottom line to me that erases much of the confusion - Based on the SIRFLOX study, if I had inoperable liver cancer I would want SIR-Spheres without question. It’s additional to the current standard of care rather than a replacement so no risk there, toxicity is highly acceptable for the outcome and a statistical significant 8 month improvement in the organ most likely to kill and a threefold increase to 6% in complete response rate. Sure Overall survival is not yet proven – but I’m not going to die waiting for that.

Investors cared a great deal about the primary end point miss but Oncologist didn’t seem to give much of a hoot and in fact SRX was awarded as one of 71 “best of ASCO” from thousands of data presentations and all key opinion leaders were positive on the results.

The data to mandate 1st Line is not there without OS data which won’t be available until 2017 but patients and oncologists are going to be much more exposed to the data and it’s much more compelling than it has been previously. Not forgetting to date SRX has already achieved 40+ quarters where growth in dose sales has been ~ 20%pa.

SRX has always said they expected the ramp up to be more like turning on a tap then flicking a light switch. I’m looking for that tap to start winding from now – enough flow (growth in dose sales) and SRX could still be a bargain @ $30.00

Back to watching dose sales and hoping in the meantime Bayer or Roche don’t think us Aussies under appreciate our SRX and lob in something opportunistic.

I think from memory SRX have hotcell capacity to approx quadruple sales. There’s a reasonable lead time for a new facility – this is a space to watch because any further expansion in the medium term could be an early indicator of what management thinks the growth trajectory is shaping up like.
 
More data out, looks good to me.

Considering how extremely expensive bevacizumab is – it will want to be doing something pretty incredible for extra-hepatic disease to continue justifying its inclusion in standard of care. Because this latest data shows Sir-spheres trounces it in effectiveness in the liver (at a fraction of the cost) and Spheres is a one off treatment compared to ongoing for Bev.


This data surely has to have implications for Roche who sell bevacizumab and they are one of the threats to SRX staying Australian.
 
That's enough for me.
I owned Sirtex indirectly through my HHV shareholding but have just bought them directly also.

Been eyeing this one for years, should have bought in more seriously earlier.
 
More great data. If they can knock Avastin out of the treatment regime that has the benefit of not only being far cheaper but also from a patient QoL a much better outcome during treatment. The platinum based chemo drugs are bad enough without having to take regular doses of Avastin as well.
 
Plugging the numbers into the spreadsheet...it just doesn't get much better in terms of textbook operating leverage.
Increased dose sales at close to 20% combined with increased selling prices = big earnings jump.

Outlook statement refers to the continuation of historical growth rates going forward.
 
There was some interesting discussion around the ASCO conference and what it would mean going forward. 3,500 oncologists the majority of whom had not heard about Sirtex or Sirspheres. The study data has become a powerful foot in the door for the salesforce on the ground. Also the trend toward personalised courses of treatment and away from the historical standardised treatment will benefit SRX. The call is well worth listening to you can pretty much skip over the CFO's presentation, but Dr Cade's presentation is worth the time.

On the other forum there is at least one oncologist posting about SRX.
 

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