MSB acquired OSIRIS in Sept 2013 ($50m -$100m transaction). At the time , it was noted that some of the major drivers for this transaction were Mesoblast’s evaluation of the use of Prochymal® for inflammatory diseases of the bowel, including patients with Crohn’s Disease who have failed other biologic agents and patients with potentially life-threatening Graft Versus Host Disease (GVHD) involving the gut and liver after a bone marrow transplant.
To balance Alexeys opinion and article dated 10 May 14 , have a read of ASX release 14 Nov 2013 (Independent results published in respected Biology Journal) .
Also Eddison Research analyst report dated 26 Nov 2013(google) includes the following extract:-
...“Clinical – Phase IIIs miss primary endpoints, but positive effects in visceral GVHD Headline results from two Phase III studies of Prochymal in GvHD were announced in 2009: Front-line aGvHD (combined with steroids) – in this 192-patient trial (mostly skin GvHD), Prochymal showed no significant difference vs placebo (45% vs 46%) in the proportion of patients that had a complete response, no second-line therapy, and survived at least 90 days. Second-line aGvHD – in this 260-patient study (61 liver GvHD, 71 gut GvHD) Prochymal was similar to placebo (35% vs 30%) on the primary endpoint of complete response lasting at least 28 days. However, Prochymal showed significantly better durable complete responses in the subgroups with liver (76% vs 47%, p=0.026) and gut (88% vs 64%, p=0.018) GvHD. Also, data from the paediatric subgroup (n=28) showed a trend to improved responses (86% vs 57%).
Based on these results, Prochymal received conditional approval (Canada, New Zealand) for paediatric steroid-refractory aGvHD in 2012 but has not been launched in either territory. It is also available in the US under the FDA’s Expanded Access Program (EAP) for the treatment of steroid-refractory GvHD in adults and children (used in c 60% of paediatric patients).
Recently published data suggest that Prochymal can significantly improve response rates and survival in children with severe, steroid-refractory aGvHD. The open-label study included 75 children with life-threatening aGvHD, who had received Prochymal under the EAP. This was a challenging population – 88% aggressive Grade C/D disease, failed three prior immunosuppressive agents, 91% major organ involvement (87% gut) – with poor survival prospects (c 5% at day 100). Results showed an overall response rate (complete + partial) of 61% at day 28, with responses seen across all disease grades and involved organs. Moreover, response to Prochymal at day 28 was a significant predictor of improved survival at day 100 (76% for responders vs 28% for non-responders, p<0.001). Prochymal was also safe and well-tolerated in this paediatric population”........[end of extract].
Also , not sure if you aware but under the Expanded Access Program in US – in excess of 200 Paediatric Patients have been treated to date...tell me that this not good news !!
In support of the above (and as per recent update/presentation), the FDA have given Meso the pathway for accelerated approval which will require an additional 60 patient trial . This will be done simultaneously with the adult trial in the liver/gut subset.
Madonion 87 noted is was a mere $50m . Not really mere for a company that dosent earn any income and had around $300m in cash at the time.
Part of the OSIRIS platform is now being referred to as TIER 1 application and their investing heavily in it.
So my question only is what did the Professor and the Adelaide MPC scientists see or understand that Osiris didn’t ?
Time will tell.
I also accept that there are other scientific developments which are promising and this is good for world health and competition.Meso is just one of the companies capable of a Paradigm shift in how people get treated for specific applications.
Finally in your earlier post (dated 7/8/14), you wanted to know what impact would Cytori’s halting of its Phase II CHF trials due safety concerns would have on Meso ?
Have a look at MSB’s website which has a lot of info around CHF (P2 safety trials ticked and we had unexpected efficacy – see ASX 10 January 2011. I say unexpected because the trials were not powered for efficacy).
We are now in Phase III, recruiting across 30 centres in US .
Anyway keep doing your research and if you are genuinely interested in investing in MSB, worth getting a good appreciation of what the Lonza manufacturing deal means to the anticipated/future delivery of MSB’s platform technology.
Good week to all.
DYOR.
MSB Price at posting:
$5.12 Sentiment: Buy Disclosure: Held
(20min delay)