Scientific Stroke research concerning alpha melanocyte stimulating hormone (a-msh)

macgyver

Well-known member
Plasma α-Melanocyte Stimulating Hormone Predicts Outcome in Ischemic Stroke (published 2011)

Background and Purpose—
α-Melanocyte stimulating hormone (α-MSH) is an endogenously produced neuropeptide derived from the same precursor as adrenocorticotropic hormone. α-MSH has profound immunomodulatory properties and may also be neuroprotective.

Methods—
In this prospective observational study, plasma concentrations of α-MSH, adrenocorticotropic hormone, cortisol, and interleukin 6 were assessed longitudinally over the course of 1 year after stroke onset in 111 patients. Logistic regression was used to the effect of initial plasma α-MSH, adrenocorticotropic hormone, cortisol, and interleukin 6 on long-term outcome.

Results—
There was an early decrease in plasma α-MSH in patients with severe stroke (National Institutes of Health Stroke Scale ≥17) that normalized over the course of the year; these same patients evidenced elevations in plasma cortisol and interleukin 6. Higher initial plasma α-MSH, but not adrenocorticotropic hormone, cortisol, or interleukin 6, was independently predictive of good long-term outcome.

Conclusions—
This research is the first to study endogenous changes in plasma α-MSH after stroke. The independent effect of early plasma α-MSH on stroke outcome, as well as a growing body of experimental data demonstrating improved stroke outcome with exogenous α-MSH administration, suggests a potential therapeutic role for α-MSH in the treatment of stroke.
 

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macgyver

Well-known member
The following patent held by AbbieVie (recently posted to Google Groups by Uhoh) is IMO a good contender for a license issued to Clinuvel for ischemic conditions (stroke, myocardial infarction). A license best explains why no related patents concerning stroke treatment under Clinuvel can be found, nor any dosing regimen patents.


Concerning dosing rights, its plausible that since no one has used afamelanotide for ischemic events in human trials, the dosing regimen is still yet to be determined. From my understanding, a Phase 2b trial is or can be used to determine optimal dosing of the drug once safety has been established in Phase 2a. An ideal scenario would be for Clinuvel to obtain a license such as the above patent (which expires in 2028), determine dosing regimen and obtain dosing IP for the targeted indications, have the protection of both IP until the license expires in 2028 (which by that time the AIS program if successful is complete and sales well underway), and then maintain dosing regimen rights well beyond 2028.

In a way Clinuvel is correct if they say they have dosing rights, simply because currently no other company can possibly determine dosing with an a-msh analogue for ischemic events (would bremelanotide work here?). That probably holds true for other treatable indications as well. If Clinuvel has obtained a license for the aforementioned patent, we might see myocardial infarction as a targeted indication and dosing rights pursued for this too.

Edit: It is assumed Prenumbra will be used for treating AIS following successful completion of the Phase 2 trials (by virtue of its name and consideration of timely administration of afamelanotide due to the critical factor of time determining whether a stroke patient has an improved outcome or not).
 
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