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TOPIC: The design of the forthcoming burns-barda-trial

The design of the forthcoming burns-barda-trial 30 Mar 2014 08:49 #1464

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This might be a tiny bit more important than I realized up to a few days back.....

Lets review the CC first:

Brozak: give us an example of the clinical proofs, not the pre-clinical proofs that you just went through, but the clinical proofs that you had had in your armamentarium to give us examples of what they saw, what you had done previously. Because, obviously, the value proposition is that you have clinical data that basically says, okay, this is what you were able to do. Give us some examples of that.

Marc Hedrick - President
That starts with believe it or not breast reconstruction. So most of the women that we treated in RESTORE-1 and RESTORE-2, Japanese and European clinical trials and studies related to patients that have had radiation and partial mastectomy was important data, because that data to them showed that we could reverse the effects of radiation. There is really nothing to my knowledge out there that can reverse the effects of radiation to that degree. So I think that was compelling.

The second is that we, based on the breast reconstruction data, we partnered several years ago with the Atomic Bomb Institute in Nagasaki and one of their key researchers there, to take our technology and use it for wounds that although very small market, but a very difficult to treat market, the patient that have had radiation for cancer, had open wounds and were at a risk of dying from sepsis.

So we showed that, not only when the skin was intact, we could repair the burn tissue that when the skin was open and there was an ulcer in the context of radiation, we could heal that. So that was important data. There was several published clinical series supporting that. So that was important.

And then finally, we have taken that beyond just radiation into wound healing in general and showed anecdotally, mainly in some smaller clinical series that it can help heal wounds that would otherwise not heal. So I think add it all that up you had a BARDA team that was very excited about the possibility.


Of course, the impact of healing of radiation damage at the breast reconstruction trials was relevant, however the second reason mentioned- the Akita trials and following approval in Europe of radiation wounds, coupled with experience and clinics done in Germany (Hannover ) and France (Montpellier) of burn wounds, one can consider much more relevant and important.

I personally do NOT think that one can treat complex burn and radiation wounds with just cells- one needs a matrix too (scaffold if you like which also get some cells added) and possibly a growth factor as described in my article..

ADRCs- holy grail for radiation wounds

If Cytori gets the BARDA contract, they will need a partner with access to these biomaterials-

Olympus is one of those Companies- Medtronic and Baxter are others.
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The design of the forthcoming burns-barda-trial 30 Mar 2014 19:39 #1465

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***If Cytori gets the BARDA contract, they will need a partner with access to these biomaterials-***

Well then we are probably screwed ! I have zero faith in management closing a decent deal.

If we can use the fat why cant we use a donor site from the patient for the scaffold ?

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The design of the forthcoming burns-barda-trial 31 Mar 2014 09:46 #1467

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If we can use the fat why cant we use a donor site from the patient for the scaffold ?


Just read the article- if Hedrick says that the know-how in treatment of radiation burns comes (also) from the Akita trial, than you simply read how Akita did it.

As it says in the article - he used a collagen scaffold and a fibroblast growth factor spray to enhance the healing process.

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The design of the forthcoming burns-barda-trial 31 Mar 2014 12:17 #1468

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In the context of BARDA..arent we really talking along the lines of a supply agreement vs a traditional partnership. ?

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The design of the forthcoming burns-barda-trial 31 Mar 2014 13:01 #1470

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oh yes. Mind you these materials (I believe) become part of the procedure and also might have some regulatory impact.

If you look at the record for ROBUST (with Baxter materials) thats how it would like like, I presume

ROBUST record at clinicaltrials.gov

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