Mate...the thing with these patents is that they need to carry some fairly detailed info to explain just what the patent is all about.
You and I are the beneficiaries of such detail.
How about not one...but three patient examples directly from the patent in question...
I was brimming from ear to ear as I gobbled this info up (see below Table). Yes we have come across this sort of evidence so far, but so so nice to see it finely articulated in an patent doc.
Take a look:
Red Box
Imagine, this patient had a Severe BML > 20 mm, after iPPS....down to 5 - 20...pain rating 4 down to zero...and 35% improvement in knee score.
Blue Box, as good...but then take a look at the third patient...
Green box:
Complete regression of BML? Pain form 8 to zero...and a crazy 89% improvement in knee score.
The conclusion from data from the SAS program, again form the patent doc, was as follows:
In conclusion, no adverse events were reported with the use of PPS under the TGA SAS(B) in patients with Bone Marrow Edema Lesions and suffering from osteoarthritis. Standard four week course of PPS resulted in a clearly visible BMEL reduction and improved pain and mobility scores. In further work, a dosing and treatment regimen of 2 mg/kg PPS or a fixed dose of 150 mg administered by slow SC injection twice-weekly for 6 weeks surprisingly gave consistent BMEL volume reduction and, in some cases, complete reduction of the BMEL as assessed by magnetic resonance imaging.
Clearly visible BMEL reduction and improved pain and mobility scores?
Surprisingly gave consistent BMEL volume reduction and in some cases complete reduction of the BMEL....your honour? I rest my case.
Mozz, love your words mate, but words are one thing, what's the saying...?
Ok lets see a pic, again, straight from the patient doc.
A: Before PPS MRI showing BME Lesions (arrows) effusions in joint space (arrows); High NRS Pain Score =8; Lysholm Score:37 (Poor knee function).
B: Post-PPS treatment MRI Showing complete resolution of BME lesions and effusions; Pain NRS =0 (pain resolved); Lysholm Score:65 (Fair knee function)
What you are seeing above is the complete resolution of BMLs. No more white splotches which is the fluid build up. I know @adherent will be smiling at this (he posted his own personal images and you know what, that was of his spine, yep new guys to us, the same treatment does multiple joints, it is not intra-articular!)
Important to note that there are a number of papers that discuss the important relation between BMLs and pain as well as more structural phenotypes and indeed progression of OA.
"Large baseline BMLs are associated with greater baseline knee pain, the presence of JSN at baseline, and disease progression". 2
One more case example involving back pain as described in the patent, taking the patient from a pain score of 7 down to 2 or 3.
-------------------
Patient GW, a 52 year-old male with chronic lower back pain with a Modic Type 1 pattern on MRI scan of the L3/L4 and L4/L5 region of the spine presented in the clinics with unresolved persistent pain despite current standard of care treatment with Mobic, an NSAID. The baseline NRS pain score prior to treatment with PPS was a high score of 7. Patient was administered by subcutaneous injection a dose of 150 mg fixed dose of PPS twice weekly for 4 weeks (ie a total of 8 injections). The patient experienced improvement in pain soon after the 4 th injection and after the 8 th injection (completion of treatment) experienced a significant reduction in pain recording a low NRS pain score of 2 to 3.
During the course of the treatment the patient had abstained from any other therapeutic intervention. No adverse events were experienced during and after the course of PPS treatment. In further work, a dosing and treatment regimen of 2 mg/kg PPS or a fixed dose of 150mg administered by slow SC injection twice-weekly for 6 weeks surprisingly gave consistent resolution of Modic Changes as assessed by magnetic resonance imaging.
It will be appreciated by persons skilled in the art that numerous variations and/or modifications may be made to the above-described embodiments, without departing from the broad general scope of the present disclosure. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive.
--------------------
PAR holders, I ask you again...
Do we indeed know what we own?DYOR prudent
Ref
1)
https://patentscope.wipo.int/search/en/detail.jsf?docId=US300735814&_cid=P21-LBIO1X-10501-12)
https://arthritis-research.biomedcentral.com/articles/10.1186/ar4292#Tab3
(20min delay)