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TOPIC: published phase 2 show stem cells heal heart

published phase 2 show stem cells heal heart 10 Apr 2013 08:53 #377

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Well this can only be seen as positive for the industry. From what I am reading this looks expensive. Wonder who will be paying for the phase 3
www.postbulletin.com/life/health/phase-ii-study-suggests-stem-cells-heal-heart-phase-iii/article_a59827d5-8d4d-5341-a415-2561cd0f8f50.html
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published phase 2 show stem cells heal heart 10 Apr 2013 09:49 #378

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This article was probably written as a result of the publication in the cardiology journal. The results themselves are from 2010 and I knew them a long time already- at least they are on my hard drive.

this is copied from the Cardio3 homepage-

Cardio3 BioSciences Clinical and Pre-Clinical Programmes

Cardio3 Biosciences’ Cardiopoiesis platform is based on technology discovered at the Mayo Clinic, the number 2 hospital in the US second to John Hopkins, and number 2 in Heart and Heart Surgery, second to Cleveland Clinic. The Cardiopoiesis platform is designed to drive the differentiation of multipotent stem cells to the cardiac programme.

The power of the Cardiopoiesis platform can be illustrated by the following highlights from the Company’s clinical and pre-clinical work: an 18% increase in left ventricular ejection fraction (LVEF) versus baseline of Chronic Heart Failure patients (C-Cure) and a 70% reduction in infarct size in an acute myocardial infarction (heart attack) animal model (C3BS-GQR-1).

Cardio3 BioSciences is focusing its activity on demonstrating that its lead product candidate, C-Cure, is able to improve the condition of patients suffering from Chronic Heart Failure secondary to ischemic cardiomyopathy. C-Cure is a stem cell product candidate derived from the patient’s own bone marrow and guided to cardiac lineage cells.

Cardio3 BioSciences announced in November 2010, positive six-month results from its Phase II clinical trial of C-Cure. The primary objective of this trial was to assess the safety and feasibility of C-Cure.

Beyond meeting the safety objective as assessed by an independent safety board, the trial revealed that six months after receiving C-Cure, patients in the treatment group showed significant functional and clinical benefit.


C-Cure Study Summary :

45 patients with heart failure secondary to ischemic heart disease were recruited in Belgium and Serbia, and randomized to optimal medical care or optimal medical care plus C-Cure treatment. Demographic and clinical baseline data were similar between 24 controls and 21 patients treated with C-Cure.
The study showed that delivery of C-Cure is feasible without peri-procedural complications. No evidence of cell-induced systemic toxicity or pro-arrhythmogenicity was observed.
Cardiac structural and functional parameters, assessed by echocardiography at six months versus baseline showed the benefit of C-Cure treatment.
On average, left ventricular ejection fraction (LVEF) was significantly augmented over baseline in the C-Cure versus control cohort (5.2±0.6% versus 1±0.7%, p < 0.01), translating into a 18.1±2.3% relative increase in systolic function afforded by cell therapy.
Reduction of end-systolic volume was 3-times larger in the C-Cure group compared to the control group (from 171±9 to 150±9 mL, and from 167±8 to 159±8 mL, p=0.01, respectively).
In contrast to the control cohort, which displayed inter-individual variance, C-Cure treatment invariably led to a pattern of improved left ventricular function in all individuals at 6 months follow-up.
The beneficial effects on cardiac structure and function in the C-Cure group translated into meaningful improved fitness. The 6-min walk test, an index of overall performance, increased from 396±26 at baseline to 449±35 m at six months in C-Cure (+52±19 m) patients while it decreased from 412±19 to 391±25 m (-21±14 m) in the control group between the same time points (p<0.01). To summarize, at 6 months post-therapy, C-Cure treated heart failure patients walked 73 meters more than patients that received optimal standard of care.
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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:

published phase 2 show stem cells heal heart 10 Apr 2013 13:33 #379

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Well this seems to be getting some press coverage now. Science daily among some others... I will cost quite a bit because of the processes involved. Fas How do you think their results compare to Cytori's?
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published phase 2 show stem cells heal heart 10 Apr 2013 15:00 #380

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I think those results were very encouraging- at least a lot better than the ones I have seen from Mesoblast, who treated similar type of patients. It seems to work a lot better with HF patients probably with a lot of dilation than Resvascor, but obviously yes- the procedure will be expensive just like the one from ASTM if they get that far.

Its not so well comparable to PRECISE- patients had chronic ischemia with LVEFs of 42 or something. These HF patients must have had baselines of 29/30 on average, when I calculate the 18% on the baseline 5 EF points increase. You can gain more from a low base if you know what I mean. (although Mesoblast did not gain very much at all)

It looks good- but they are going for a different patient population I would say.
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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:

published phase 2 show stem cells heal heart 14 Apr 2013 21:28 #387

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I am not sure that all investors know that Cytori has submitted all of the Precise Trial data to a peer review board (whatever that means). I learned this over a month ago. It is amazing to me that Cytori chose to spend all of its energy trying to get CMI approval in the EU using a trial that had never been peer reviewed and published. Now that the EU has said "we need more data", Cytori is taking the time to submit the trial data for peer review and publication.

Fortunately for stockholders, Cytori is no longer trying to take short cuts to hit the home run. Athena and Barda are straight forward trials that will be significant turning points for the entire field of regenerative medicine. Having said that, Barda would not have been won had it not been for the observations from breast reconstruction treatments using ADRCs.

While it certainly feels that the last 30 months of stock ownership has been a total waste, in actuality, much has occurred under the radar. If I were just learning about Cytori's story, I would be buying aggressively now. The real action will be in a year or so when today's purchase will be a long-term gain. I don't plan to be an active poster until there is something really worth writing about. My gut feel is that the next capital raise will come as a surprise in the August time frame. Until then :vegas:
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published phase 2 show stem cells heal heart 15 Apr 2013 02:21 #388

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DOV - Can I assume that you do not see any partnership agreements in the near term? :cry: ........ note that I did not use the subjective adverb "very"........ and yes I acknowledge that "near" is also subjective.

As for the wasted time in pursuing the CMI approval in the EU I do not agree that it was a waste of time. Had they waited for peer review and then started the process this would have taken up a considerable amount of time. I can only assume that given the small trial size this would have been a major facilitator in the EU authorities capability of reviewing the data. I am not sure that the peer review was a necessary prerequisite. In any case the early engagement with the EU authorities provided that necessary enagement that led to the decision to proceed with the ATHENA trial. Hopefully that data will be supportive of a positive decision in the EU going forward........ ATHENA is enrolling quickly and VERY similar to PRECISE.

Also lets not forget that there were no peer reviewed papers for the various indications listed below for which we have already received CE approval in the EU, (breast reconstruction being the exception) :winky:

•Fistula's including Cryptoglandular fistula
•Deficiency or injury of: skin, fat, muscle and fascia
•Soft tissue wounds, ulcers or fistula associated with trauma, diabetes, ischemia or radiation injury
• Tissue ischemia

I do agree with you that much has been done, and is being done under the radar. Waiting is a bitch....... but I look at Mesoblasts market cap and see no reason why it could not be CYTX :yep: 10 bagger
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published phase 2 show stem cells heal heart 15 Apr 2013 08:08 #389

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rongside...I tend to agree with you that trial size with Precise was likely a bigger factor than not having the peer review, but I can also see maybe the peer review issue played a role as well. Didnt we hear from CYTX that more European data was going to be needed ? DOV are you suggesting that this "data" may simply be peer review ? In the endless time span that we waited for a NO from the EU, if this was the sole issue, dont you think CC and company could have gotten a peer review ?

From DOV:
***My gut feel is that the next capital raise will come as a surprise in the August time frame***
We all know a raise is coming, so if we are talking a surprise then for me it will be via a BP partnership.
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published phase 2 show stem cells heal heart 15 Apr 2013 12:56 #390

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Hi DOV- nice to see you here, hope you are doing well.

I am not sure that all investors know that Cytori has submitted all of the Precise Trial data to a peer review board (whatever that means). I learned this over a month ago.

That is nothing spectacular really and not a job for Cytori, but for Emerson and Paco and their crews. Surely the old wisdom there applies- institutional investors never believe the corporate announcements on important clinical work until it has been peer reviewed by other specialists in that field of medicine. That simply means it will be presented by Emerson at AHA or TCT at some point. Cytori has to do nothing there. Surely Emerson has been busy with other things- Eric Duckers has great support at Erasmus- thats why the APOLLO peer reviewed paper already came in April 2011.

Having said that, Barda would not have been won had it not been for the observations from breast reconstruction treatments using ADRCs.

I think you talk too much with those guys. I did that too for about three years and in the end I realized they were telling me fairy tales. They are very good at that. In 2007 when the protocol for RESTORE was designed, there even was a separate 20 patients clinic planned for radiation wounds. That was called VENUS and was to be done by Calabrese in Florence. That was cancelled since Akita (Nagasaki) took over. BARDA was won based on the work of Akita and the following clinics in Europe which led to the specific therapeutic claim on radiation wounds.

You are right about the "radar" thing- its all on my page and I am sure all that stuff is just the tip of the iceberg. :bash:

I myself tip on May/June for a secondary if they do not see the conclusion of a partner deal before that. Personally I "feel" it coming and believe your sister will be a very happy person at the end of the year.

So- actually I expect you back in one or two months. :bye:

Hope to see you than. :vegas:
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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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