× Off Topic on Adult (=regenerative) cell technology, but very much related i.e. pills and drugs of which we do not know if they work

No need for stem cells ?

08 Aug 2017 08:30 - 08 Aug 2017 08:52 #9789 by franshei
Hedge

I think cell therapy will remain a niche.

I really think (after a lot of thinking and rethinking) the scleroderma STAR trial is not a failure. Actually, it is one of the trials that CYTX has found some success. It works with more advanced patients (but not the most serious kind with extensive organ involvement). As long as the illness is progressive (but not life threatening) it should work. The ongoing sclerodec II and sclerodec 1 should point to this direction.

I think the inclusion of just localized sclerosis (very early stages of the illness) will not get the benefit of Habeo.

CYTX was too anxious to get a partner for this indication and the scope of STAR had been broadened to too many patients who would not receive benefits from the trial, As Hedrick has mentioned the inclusion and exclusion criteria were not followed strictly. Yet, the study was rushed through in record time for the first time in the company's history.

I think if the company would go back and go through the diagnosis again, a lot of patients may not even qualify to enter the trial. If all the genuine diffuse cutaneous scleroderma patients are regrouped and their treatment data reanalyzed, the result should not be too far off from the French study.

Just my opinion.

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08 Aug 2017 19:17 #9790 by b767cpt
Question is Franshei, how do they get the financing they need to get them through the second French trial? They have zero credibility.

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08 Aug 2017 19:36 #9791 by myownhedgefund
Well I recognized the best case was only a niche player in markets probably a couple years ago now. Many disagreed. Yet, here we are. Nearly BK again and still no niche filled.

However, I think what you described above is why no company should ever, ever partner with Cytori !!!
They are sloppy !!!!!
From both a fiscal AND scientific standpoint.

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08 Aug 2017 22:48 #9792 by rongside
A dilutive capital raise is going to be too little to late. It shows desperation and ineptitude.

We need a partnership agreement. This will also be dilutive but depending on the terms it will also confirm the validity of the treament paradigm. Anything short of a partnership (or licensing agreement) will be catastrophic for both existing shareholders, and inevitably patients who want a validated treatment process.

The French trial includes both limited and diffuse patients, so the total number of diffuse patients may be insufficient for making a determination. Also the primary efficacy point is for 3 months Cochin which given the placebo effect will be too soon to establish efficacy, Of course the 6 month data if it tracks in a similar manner to the STAR trial will be supporive.

However the French sense of urgency may not be sufficient to meet CYTX requirements with the FDA. Also, the FDA is unlikely to allow merged, cherry picked data sets to be a basis for approval

From a clinical perpective the only thing that can turn the tide is unequivocal supporting CLINICAL data, ... especially digital ulcers. Ideally we would want data showing that there were NO/VERY FEW new DU in the treated arms (both limited & diffuse) vis a vis the placebo group. Also we would want a SS number of DU that existed at baseline in both limited & diffuse treated patients to be healed vis a vis the placebo patients.

I don't know whether this data exists or would be enough for the FDA, but it should be compelling for any serious potential partner, if they have not all been driven off. Such data would bode well for all types of wound conditions.

This data surely exists and should be easily verifiable. If positive, it is a strong tool in the negotiation process. Whether the hands that hold this tool are strong is debatable.

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09 Aug 2017 09:08 #9793 by fas

rongside wrote: A dilutive capital raise is going to be too little to late. It shows desperation and ineptitude.


I don't know whether this data exists or would be enough for the FDA, but it should be compelling for any serious potential partner, if they have not all been driven off. Such data would bode well for all types of wound conditions.

This data surely exists and should be easily verifiable. If positive, it is a strong tool in the negotiation process. Whether the hands that hold this tool are strong is debatable.


Fully concur with your post.

The financial math on a capital raise is simple- the non-committed share capital of the total allowed -75 Mio- is 35 to 40 Mio available- could raise 7-8 Mio at 20 cents. Survival for a quarter with the over-blown salaries.

Beyond STAR and Act-OA there are still hard scientific data from the Naples study, several other IIS studies and not to forget the ADVANCE data which we still do not know. To me - I repeat again- acute injury is -for me- the most likely to succeed therapeutic area for fresh auto cells and -again to me- APOLLO proved that.

We have to watch the upcoming events very carefully and be prepared for anything to defend ourselves.

Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

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