MSB - Mesoblast Limited

[greggles]

Interesting perspective GB. Thanks for your thoughts.

Why do you think Grünenthal Group is throwing so much money at this? They appear to be a pretty reputable German outfit with a great deal of experience in the pain management field.

Grünenthal is a global leader in pain management and related diseases. As a science-based, privately-owned pharmaceutical company, we have a long track record of bringing innovative treatments and state-of-the-art technologies to patients worldwide. Our purpose is to change lives for the better – and innovation is our passion. We are focusing all of our activities and efforts on working towards our vision of a world free of pain. Grünenthal is headquartered in Aachen, Germany, and has affiliates in 30 countries across Europe, Latin America and the US. Our products are available in more than 100 countries. In 2018 Grünenthal employed around 4,900 people and achieved sales of € 1.3 bn.

Surely they must see a lot of potential in MSB's Phase III trial for MPC-06-ID?

 

[Gringotts Bank]

Interesting perspective GB. Thanks for your thoughts.

Why do you think Grünenthal Group is throwing so much money at this? They appear to be a pretty reputable German outfit with a great deal of experience in the pain management field.


Surely they must see a lot of potential in MSB's Phase III trial for MPC-06-ID?

Thanks. The terms 'reputable' and 'experienced' are poorly correlated with real insight, actionable knowledge and successful outcomes. They just don't know what they're doing, and it's very common in the field of pain science.

 

[Knobby22]

It doesn't address all forms of back pain, just inflammation which is normally treated by steroids.
The trial results so far are pretty good wouldn't you say?
Do you work in the area?

 

[Gringotts Bank]

It doesn't address all forms of back pain, just inflammation which is normally treated by steroids.
The trial results so far are pretty good wouldn't you say?
Do you work in the area?

The phase 2 trials were done against control groups (saline, HA), but that's a far cry from a double-blinded trial. So the charts look good, but they mean nothing.

Even if the phase 2 was double-blinded and all you got was a situation where half the patients had a 50% reduction in pain, that's pretty useless. I can name a few individual practitioners who would smash that sort of response rate without resorting to invasive methods.

Yes.

Consider a recent paper in Lancet which said (paraphrasing): there's no medical or surgical intervention which has proven effective for LBP. Millions of studies have been directed at the wrong mechanisms and it continues to this day. There's a lot of very rigid, old-fashioned thinking in the pain science field. https://www.monash.edu/news/article...ence-of-medical-negligence-and-misinformation

 

[Knobby22]

Thanks Gringotts Bank. Good points.

The method or argument of efficacy is as follows: it is sort of like a stem cell treatment.
I do think there may be a case but you may be right and it fails the phase 3 testing but it also is a novel approach and may succeed.

MPC-06-ID is a Phase 3 product candidate for the treatment of chronic low back pain caused by disc degeneration (CLBP). It is being developed for patients who have exhausted conservative treatment options, may have failed epidural steroid injections and have no further treatment option other than invasive and costly surgical interventions.

Disease Indication and Patient Population

Over four million patients in the United States alone suffer from CLBP1,2,3,4 , which is caused by damage to the disc as a result of aging, genetics, and injuries. This compromises the disc’s capacity to act as a fluid-filled cushion between vertebrae and to provide anatomical stability. Damage also causes an inflammatory response with ingrowth of nerves that result in chronic pain. This combination results in CLBP and functional disability.

When disc degeneration has progressed to a point that pain and loss of function can no longer be managed by conservative means e.g. medication and physiotherapy, major invasive surgery such as spinal fusion is the only remaining option.

Existing therapies treat the symptoms of the disease, but are not disease-modifying and thus do not address the underlying disease cause. As a result, we believe that the most significant unmet need is a therapy that can not only improve the patient’s pain and function, but has the ability to reverse, halt or slow disease progression.

By treating the cause of CLBP, we believe MPC-06-ID could fill an unmet treatment gap for a large population of patients.

MPC-06-ID

MPC-06-ID is a tier 1 product candidate which consists of a unit dose of 6 million mesenchymal precursor cells (MPCs). It is injected by syringe directly into a targeted damaged disc in an outpatient procedure.

Mechanism of Action

Extensive preclinical studies have established that MPCs have anti-inflammatory effects and secrete multiple paracrine factors that stimulate new proteoglycan and collagen synthesis by chondrocytes in vitro and by resident cells in the nucleus and annulus in vivo. MPCs have also been shown to produce anti-inflammation factors. Together these effects offer the potential to strengthen the load bearing function of the disc by increasing its water content, improving disc anatomy and stability, while also reducing inflammation and pain.

 

[Gringotts Bank]

In their latest ann., they cite various crap studies as a basis for their stem cell treatment.

"Moderate to severe disc degeneration as a cause of chronic low back pain occurs in over 3.2 million patients in the United States3 and approximately 4 million in Europe".

LBP is very common, but disc degenration does not cause LBP. So the proposed MSB "treatment" is based upon bad research.

The truth is here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4464797/

"CONCLUSIONS
Imaging findings of spine degeneration are present in high proportions of asymptomatic individuals, increasing with age. Many imaging-based degenerative features are likely part of normal aging and unassociated with pain. These imaging findings must be interpreted in the context of the patient’s clinical condition".


Whether the SP rises or not, that's another matter.

 

[Knobby22]

So if the studies Mesoblast quote are rubbish and this study is correct then the population that this product can treat is likely much smaller than Mesoblast hint at. The product may help where inflammation is the main problem but reducing disc deteriation is probably pointless.

So what is the main cause of lower back pain?

 

[Knobby22]

Herniated disc seems to always mentioned.

Overuse is mentioned as common but pain is short term.

 

[Gringotts Bank]

So if the studies Mesoblast quote are rubbish and this study iscorrect then the population that this product can treat is likely much smaller than Mesoblast hint at. The product may help where inflammation is the main problem but reducing disc deteriation is probably pointless.

So what is the main cause of lower back pain?

The brain produces pain in every instance, whether it's a burn, cut, sprained ankle, broken bone or back pain. The brain is weighing a huge number of inputs in real time, and it ouputs 'pain', or 'no pain'. It happens beyond our conscious awareness. This is mainstream science; it's just that most healthcare professionals aren't aware of it yet. And the public certainly isn't.

Tissue damage is only one of the inputs that the brain is measuring, and for tissue damage to end up as pain, it needs to be quite major. Disc degeneration - even if severe - doesn't qualify as tissue damage. It's more like 'wear and tear'. The most powerful input for the brain's decision-making process is emotional stress, particularly if it's repressed.

10s of millions of people in the world have disc degeneration...yet, no symptoms. So obviously it's not the singular cause of back pain.

All pain is inflammatory in nature. And stress is known to be the most potent cause of inflammation. Stress can cause severe inflammation even in the absence of any tissue damage (via the nervous system).

Research has shown stress reduction to be the single most powerful natural analgesic. If you were to compare a decent stress reduction event with a powerful opiate like Tramadol, stress reduction would win out easily. But obviously stress reduction can be hard to achieve rapidly if the issue is big/tricky, and that's why people use medicines. Nothing wrong with that.

Basically it's all about stress. But for immediate relief, curcumin with black pepper is a potent anti-inflammatory. Opiates are good too (short term use only).

 

[Gringotts Bank]

Herniated disc seems to always mentioned.

Overuse is mentioned as common but pain is short term.

Overuse is easy to fix. Just stop. Next time use better posture with lifting, bending etc. Pain goes away immediately.

Massive herniated discs can sometimes need surgery, but they can also heal themselves sometimes. However, even when the disc doesn't heal (still showing on MRI), the pain usually disappears in about 80% of cases without any intervention. What does that tell you!? One day you have a disc bulge and pain; weeks later you have a disc bulge and no symptoms. Happens all the time.

 

[Knobby22]

A raising at $2.
I sold 1/3 of my shares and planned to buy them back at $1.60. Price wouldn't drop, now I know why.

 

[Gringotts Bank]

A raising at $2.
I sold 1/3 of my shares and planned to buy them back at $1.60. Price wouldn't drop, now I know why.

Fundamentals aside, $2 looks like a good entry point, if it trades there. Bottom of the flag.

 

[jjbinks]

I was reading that trading was halted today for capital raising.

This might be followed by a price drop vguess

 

[Knobby22]

Raising succeeded at $2.

 

[Country Lad]

Raising succeeded at $2.

I must be getting old and cranky. I really dislike the convoluted announcements which are spruced up as marketing. Would have been much simpler to say:

We placed 37.5 million new fully-paid ordinary shares at a price of A$2.00 to institutional investors.
We will use the funds to build product inventory, hire salespeople in the US and to complete the current Phase 3 trials. end of statement.

Low of 192 recovered a bit to a tad under the $2 now which would be expected regardless of how they beefed up the announcement.

 

[Gringotts Bank]

A good result today given the CR and two days of steep losses on the Ords. Seems there's a fair bit of support out there among investors. But keep in mind... https://simplifaster.com/articles/why-most-people-are-wrong-about-injuries-and-pain/

 

[Gringotts Bank]

Sandiego Pain Summit attracts a lot of the world's experts in pain.

Understanding and Treating Back Pain

 

[Knobby22]

My tip pick and picked by a few others I notice.
Phase 3 results coming out over the year so if the news is good, could be a big rerating.

Could be bad though.

 

[UMike]

A lot of this recent rise is beyond my simple understanding.

Been a long holder and accumulator but is it time to consider off loading these as the recent rise seems to be speculative.

 

[qldfrog]

Yes my buy on open was left behing in a cloud of smoke.. ahhh well