Cell Therapy News/Articles, page-11058

The EvidenceBased Medicine approach to treating COVID is fluid and evolving. I see an importantplace for Remestemcel in the treatment approach to COVID/Long COVID. COVID istreatable. But it seems early treatments and intervention is paramount to stopthe progression to where permanent damage is done and (minimise the effects oflong COVID). There is no room for watch and wait approach and clinicians needto throw the full army of interventions as early as possible to preventprogression of the disease process.

Furtherstudies and results will confirm Remestemcel’s positioning in the treatment anddisease cascade. In terms of the disease progression from the pulmonary aspect,it is on a continuum, preceding with the incubation period, to symptomology, andthen the ‘Early Pulmonary Phase’ which progresses to the ‘Late Pulmonary Phase’.IMO I believe Remestemcel will have a place in both of these Pulmonary Phases,however I tend to hypothesise that the earlier it is introduced in the EarlyPhase the better the long term outcomes will be for the patient. The trialdesign will be paramount to determine at what point Remestemcel is introducedto the Treatment Paradigm. I hypothesise the earlier the better once thePulmonary Phase takes hold, the better the outcome will be in terms ofRespiratory symptomology and potentially reducing long COVID symptomology. IMOI would hypothesise earlier administration of Remestemcel may also contributeto less disease progression on a number of fronts post hospitalisation includingCV symptomology, GI symptomology (as part of Long COVID) as we have evidence ofour stems working in these domain (e.g. AGVHS – improved GI, CHF – improved cardiacoutcomes). In short I believe Remestemcel may have important multimodal outcomesfor Respiratory, CV, GI etc. We will see as further data is analysed from theinitial COVID trial. I am not sure of another intervention which can attackCOVID from as many angles. And this is no time for watch and wait – even if wecannot yet elucidate exact method of action.

In terms ofCOVID ARDS versus ALL CAUSE ARDS (the latter Novartis is in this area) there seemsto be increasing evidence of some differences between the two at leastinitially. COVID ARDS initial attack on the respiratory system is more like an organisingpneumonia (seen through imaging – ‘ground glass infiltrates are peripheral& patchy, and do not resemble the dependent air space consolidation(sponge/baby lung) seen with all cause ‘typical’ ARDS’.

In short if Remestemcel’sMOA is to dampen the ‘cytokine storm’ it would seem likely that thisintervention will be effective in both phases of the attack on the lungs. Itwill be interesting to see at what stage it will be given should it proceed totrial. Introducing it earlier IMO is the way to go (sort of similar to theoutcomes in the CHF trial where earlier intervention lead to better outcomes throughless disease progression).

On adifferent note, it will be interesting if Novartis signs how future trials willproceed. From the literature it would be wiser IMO to separate out COVID-ARDSfrom ALL CAUSE ARDS as it is becoming clearer to the scientific/medicalcommunity that treating COVID patients the same as ALL CAUSE ARDS patients maybe fraught with danger.

So will Novartisbe keen on a new market being COVID ARDS. I expect so, because it expands ontheir existing interest in ALL CAUSE ARDS (their longer term play IMO). As suchI am not surprised Novartis is not jumping in straight away with COVID ARDS, asit may differ in the treatment approach to ALL CAUSE ARDS. This extra time in finalisingthe agreement is likely a positive thing, because it allows us to get both trialsright now that the differences are becoming clearer between the diseases whichshare the same terminology ARDS. IMO this means Novartis are in it for the longerterm (not as a short term see if it works approach), especially also becausethey are interested in other application of our technology, namely CHF as anext step.

Good lucklong and short term holders. It will be a very exciting next year to say theleast.

Please doyour own research and this is in no way financial advice.