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TOPIC: Good news from Naples

Good news from Naples 30 Jul 2013 12:38 #695

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On the German Cytori board - a CYTX shareholder- Wolfgang discovered a nice paper on a small clinic done in Italy on chronic ulcers (with Celution)

This is the abstract- I am reading the full paper at present and think its important enough to devote a blog article on it. :nice: The healing pics are simply amazing.

Therapy with autologous adipose-derived regenerative cells for the care of chronic ulcer of lower limbs in patients with peripheral arterial disease
Gerardo Marino, MDCorresponding author contact information, E-mail the corresponding author, Marco Moraci, MD, Emilia Armenia, MD, Consiglia Orabona, MD, Renato Sergio, MD, Gabriele De Sena, MD, Vincenza Capuozzo, MD, Manlio Barbarisi, MD, Francesco Rosso, MD, Giovanni Giordano, MD, Francesco Iovino, MD, Alfonso Barbarisi
Laboratory of Applied Biotechnology, Department of Anesthesiology, Surgery, and Emergency Sciences, Second University of Naples, Naples, Italy

Abstract
Background
An ulcer is a trophic lesion with loss of tissue that often has a multifactorial genesis. It typically diverges from the physiologic processes of regeneration because it rarely tends to heal spontaneously. In this study, we used purified adipose-derived stem and regenerative cells (ADRCs) extracted from autologous fat, for the care of chronic ulcers of the lower limbs of arteriopathic patients. The primary objective of this study was complete re-epithelization of chronic ulcers; the secondary objective was a decrease in diameter and depth.

Methods
From January 2010 to January 2012, 20 patients with peripheral arterial disease, with an ankle-brachial index between 0.30–0.40, in the age range 60–70 y (14 men and six women), with chronic ulcers of the lower limb, were involved in the study. Only 10 arteriopathic patients (seven men and three women) with chronic ulcers of the lower limb were surgically treated. Using the Celution system, we isolated a solution of ADRCs in about 150 min. The isolated cells were injected through a 10-mL syringe into the edges of the ulcer, taking care to spread it in all directions. Using a small amount of Celution extract, we performed cell characterization by flow cytometry analysis and cell viability assay.

Results
We monitored patients treated with ADRC or untreated at 4, 10, 20, 60, and 90 d. In all cases treated with ADRC, we found a reduction in both diameter and depth of the ulcer, which led to a decrease in pain associated with the ulcer process. In six of 10 cases there was complete healing of the ulcer. Characterization of the cells by FACS clearly showed that the ADRC cells contained adipose-derived stem cells. Viability assays demonstrated that partial or total closure of the ulcer was attributable exclusively to ADRC cells present in the Celution extract, and not to growth factors extracted during the process of purification of the Celution and injected together with the cells.

Conclusions
For the first time, the Celution method has been applied for the care of chronic ulcers in the lower extremity of patients with peripheral arterial disease. Our results demonstrate that the technique is feasible for autologous cell application and is not associated with adverse events. Moreover, the transplantation of autologous stem cells extracted with Celution may represent a valuable method for the treatment of chronic ulcers in lower limbs of arteriopathic patients.

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Good news from Naples 30 Jul 2013 19:55 #696

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Thanks Fas and please thank Wolfgang on the German board for us.

I look forward to a blog post on the subject and please include those pictures as well.

The sad part of course is 18-19 months post this trial and no partnership for the indication. Of course, there is the possibility of either the trial was expanded further or additional wound types have been added to testing for a broader wound platform to base a price on. Still frustrating that we cant promote our clinical success stories !!! :bash:

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Good news from Naples 30 Jul 2013 23:12 #697

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That data is amazing. Basically they had statistical significance with a 20 person trial. ( open to interpretation.)
Those kind of results are unheard of in clinical trials. This treatment does not need a 1700 patient randomized study to prove efficacy. A trial that takes years to complete and shows that its marginally better than standard of care.
Common sense and capitalism will bring these therapies to market...(hopefully)

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Good news from Naples 31 Jul 2013 09:29 #699

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The Blog article "Good News from Naples-Italy is online now. You will find it at the usual place.

Tomorrow I will add an characterization piece to it. But it is legible now, albeit a bit technical for the average investor,I presume. :write:

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Good news from Naples 31 Jul 2013 10:03 #700

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Just another tip-

all pictures with a "loop" at the bottom you can click on and they blow up across your screen so you can view them better.

In the paper their were some more highly impressive ones, but I dont want to "challenge" my luck in using other folks work.

This should give a good enough impression :nice:

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Good news from Naples 31 Jul 2013 12:57 #701

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Getting access to this article from our German friend (Wolfgang) via Fas's website is proof positive of the effectiveness of this platform. It is also proof that:

1. as a group when we share information through a forum such as this we all become more capable of discerning the true potential ADRC.
2. the vaaaast investing public has NO IDEA about the potential of this technology (Celution).
3. CYTX is not at all proactive in providing information to investors about its outside researcher development programmes. Certainly a press release with some information about the PAD trial was a reasonable expectation, given that results were already published in a medical journal.

Great find.... great validation of the technology. :woohoo: Shire must be wondering about its competitative position vis a vis CYTX right now in the wound healing space.

Fas in your blog article you raise the question of whether intravenous application of ADRC may be a better methodology for addressing PAD than simple injection around the periphery. No doubt a valid question................ but there is no end to the questions that can be posed.

How do you see CYTX going forward in this indication? There does not appear to be any reference to any sponsor of this trial. Both forms of treatment whether intravenous or peripheral injection do not appear to need inclusion of another partner. Does CYTX go this alone or not? Does the partner (potential) just supply the money and clinical trial expertise. How do you price this and what type of wound healing indications do you partner .... specific ones, or across the board?

I don't expect you to know .......... just thought it might be interesting to focus on the commercial pathway for a change, as in the end this is the conclusive validation we all seek.

By the way good call on the Puregraft sale. It happened sooner than I thought. As a conspiracy addicted Greek I do ask myself however, what do they know about Alopecia that we don't? .............. :evil:
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Good news from Naples 31 Jul 2013 14:17 #702

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By the way good call on the Puregraft sale. It happened sooner than I thought. As a conspiracy addicted Greek I do ask myself however, what do they know about Alopecia that we don't? ......


John- right on- conspiracies. :KO: This is typical Cytori- they simply do not seem to know, what they know themselves ( and a few lucky shareholders of course) and what the rest of the shareholders know. i.e. NADA- NOTHING. I guess this is also why I am doing what I am doing. :really:

Alopecia-

- presented as everybody knows the term- just like IntraVase once- but nobody knows.

I guess I am one of the lucky few since CC told me about a hair growth app. Its all about ischemic tissue probably- men´s skin becoming more fibrous and not being perfused i.e. served with blood flow and the hair is lost. But who cares? I kept it for myself, like the info being a corn of sand on the beach- but yes, maybe it is successful. Would be nice to know if some of the present "leaders" have stakes in the outfit. :grin:

Cytori is like organisation not knowing how to present its potential to the market because of all its complexity, secrecy and yes conspiracies. :bash:

But I can live with that although its sad really.

I will answer your other questions tomorrow- the A´s are due to start their game anytime. :bye:

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Good news from Naples 31 Jul 2013 20:58 #704

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Thank you for that blog Fas..What an eye opener. Dermagraft is an improvement over standard of care but ADRC's are a home run.
I would think that there is a possibility that a phase 3 pivotal could start in Europe. I would hope it has 3 arms. Standard of care, Dermagraft and Cellution. What is really exciting is that the dermagraft trial was a 12 week study and only enrolled 314 patients. This study could be completed quickly. Looks like low hanging fruit to me...

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Good news from Naples 01 Aug 2013 07:54 #705

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I would think that there is a possibility that a phase 3 pivotal could start in Europe. I would hope it has 3 arms. Standard of care, Dermagraft and Cellution. What is really exciting is that the dermagraft trial was a 12 week study and only enrolled 314 patients. This study could be completed quickly. Looks like low hanging fruit to me...


Joey- why would you do another clinical trial if you have market authorization?
It requires a big marketing group (from a partner) to pound the doors of surgeons working in that area of medicine. :yawn:

Doing this in the US - yes- that would make sense to me. :woohoo:

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Good news from Naples 01 Aug 2013 08:17 #706

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How do you see CYTX going forward in this indication? There does not appear to be any reference to any sponsor of this trial. Both forms of treatment whether intravenous or peripheral injection do not appear to need inclusion of another partner. Does CYTX go this alone or not? Does the partner (potential) just supply the money and clinical trial expertise. How do you price this and what type of wound healing indications do you partner .... specific ones, or across the board?


John- History has proven that Cytori is not very successful in sales and marketing matters. But I know Chris Calhoun by now- he will try again when the opportunity arises and will be sufficiently funded to set up an organization for that purpose. I expect the tissue ischemia/IntraVase apps to be handled by Cytori some fine day. Olympus still for wound healing and bone and Astellas for Renal and auto-immune. Just a guess but CC and Team are still very ambitious I would think and will try to maximise value for their own pocket first and shareholders later. :grin:

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Good news from Naples 01 Aug 2013 08:39 #707

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***History has proven that Cytori is not very successful in sales and marketing matters. But I know Chris Calhoun by now- he will try again when the opportunity arises and will be sufficiently funded to set up an organization for that purpose. I expect the tissue ischemia/IntraVase apps to be handled by Cytori some fine day***

Hence the latest in the long line of VP's....Vice President, Global Human Resources !!! :yep:

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Good news from Naples 01 Aug 2013 15:26 #708

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I would not think that the FDA would not allow a phase 3 start Wouldn't they start at phase 1 or 2

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Good news from Naples 01 Aug 2013 15:43 #709

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Joey-

Lets put it this way- it is Calhoun´s stated goal to leverage European clinical data in the US - I have that black on white.

That is to forsake on a device PMA pilot and go straight into an PMA pivotal trial, which should provide market authorization. Do not forget the classic Phase I, II a/b, III etc do not apply to device regulations.

Than again you might be right that the FDA accepts nada nothing - but the safety profile of ADRCs with Celution is getting more established with every day passing, so even those folks will become mellow sooner or later (I hope) :grin:

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Good news from Naples 03 Aug 2013 14:36 #712

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Fas - "Just a guess but CC and Team are still very ambitious I would think and will try to maximise value for their own pocket first and shareholders later"

They have shares, options, golden parachutes and poison pills ...... what more do they want. They have approvals for significant indications in Europe for over a year now. Can't they do both ........ make money for us and themselves ........ these are not mutualy exclusive events !!!!!! :bash:

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Good news from Naples 04 Aug 2013 06:15 #713

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John-

Maybe my sub-conscious is playing up here. I still do not comprehend the late 2012 events, where contract stage deals did not occur. I still do not understand that, especially since the likelihood of those deals being related to therapeutic claims established in Europe is extremely high.
Something must have happened and I am almost suspecting that it was CC holding his foot stiff, instead of the "other parties" walking away.
That would than explain the large options that CC received which I consider undue and defeating any logic except for the explanation above.

If correct -he has lined his pocket now and events can unfold, the way I have been expecting them for many years. :evil:

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Good news from Naples 05 Aug 2013 18:09 #714

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"That would than explain the large options that CC received which I consider undue and defeating any logic except for the explanation above.

If correct -he has lined his pocket now and events can unfold, the way I have been expecting them for many years"


Fas, the above is what concerns me. As CC and Co. have been soley focused on what is best from them and not shareholders,if they sell out
it will be the final screwing of Cytori shareholders. All to common in the biotech industry that after years and years of waiting, mangement sells out,and insiders make millions while long suffering shareholders are left holding the bag. the truth is learned only after reading the depositions taken during class action suits, which we all know benefit nobody but the lawyers. I hate being so cynical, but my lessons have come at a high cost. Hope for the best and fear the worst is all you can expect when it comes to Cytori. It's the only mantra this manage,ent team deserves.

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Good news from Naples 05 Aug 2013 22:34 #715

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I cant completely agree with you here Fas.

Did CC blow the deal expected last year...Oh, I completely believe that. Classic CC !!!

Was it done for the next options round ? Or that CC figured it was win win if the deal didnt go thru because options were getting priced soon anyway ? I dont think it really happened that way...greedy sure... crafty, No ! ...I think he just bumbles along and has done so for years because there is simply no accountability. Dean aided in the zero accountability instead of fixing it as he promised. :cry:

Also, If your senario is correct...arent we setting up for the same thing again ?
Small deals + another secondary carries us long enough for one more option award play and then sign for something bigger.
If it worked once...why not twice ? :puke:
Its not like the new COB would stand in the way of bigger management awards before a big deal signed. :bash:

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Good news from Naples 06 Aug 2013 06:24 #716

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Hedge-

I would not claim my post to be the most intelligent one coming out of my keyboard in the past months- its bleeping hot and steamy out here.

But fact is- I do not understand the events very well of last year +options. On the other hand, the unexpected study from Naples fits perfectly well in my age old theory ( which to me is not a theory any longer- but fact) of the gigantic regulatory and potential market value being created in Europe. Where there is value- there are suitors- from that perspective my theory is not that dumb. :grin:

I am daily confronted with the fact that 99% of CYTX investors do not have a clue about the tech they invested in- the ones that do basically are subscribed here and put their money where their mouth is- in CYTX stock and a clinic on the Bahamas. :yawn:

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Good news from Naples 13 Aug 2013 08:45 #751

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A nice example of what "proper IR" does and reporting study results that matter- OSIR is souring today and published interim results of the Grafix treatment on diabetic foot ulcer. That is a Phase 4 study since Grafix is non-cultured and therefore a biologic product NOT subject to clinical trials . Just the usual cGMP licenses.

This is one of the enrollment criteria-

Patient has adequate circulation to the foot as documented by either:
Ankle Brachial Index (ABI) > 0.70 and < 1.30, or
In patients with non-compressible ankle vessels defined as an ABI ≥ 1.30, a Toe Brachial Index (TBI) ≥ 0.50
In patients with non-compressible ankle vessels defined as an ABI ≥ 1.30 and TBI cannot be performed (e.g., toe is absent, wounds are present, or site cannot perform a TBI), a Doppler waveform in the posterior tibial or dorsalis pedis arteries at the ankle consistent with adequate flow in the foot (biphasic or triphasic) and other diagnostic confirmation of adequate flow (e.g., duplex imaging, normal pulse volume recording [PVR] testing).


Compared to the 63% healing rate for patients with this ABI with Grafix, ADRCs had 100% healing rate as per the Naples study -thereto much larger wounds.

Go figure yourself. :evil:
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Good news from Naples 13 Aug 2013 09:07 #752

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***Compared to the 63% healing rate for patients with this ABI with Grafix, ADRCs had 100% healing rate as per the Naples study -thereto much larger wounds.***

100%!!!! Frustrating, as we wait to bring to surface that underwater chest as referred to in another thread. :bash: :bash:

d9

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