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TOPIC: Mail on initial Scleroderma results

Mail on initial Scleroderma results 20 Sep 2013 08:29 #873

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Cytori distributed this mail to the shareholders, which was NOT (why not?) distributed to the usual news media.. :bash:

Dear Investors:

Cytori Therapeutics today announces positive early data from a study evaluating Cytori's cell therapy as a potential treatment for scleroderma, a rare autoimmune disorder. The data being reported are part of an investigator-initiated and funded, open-label pilot study in France in patients with cutaneous systemic scleroderma using Cytori's cell therapy. The results will be presented today by the principal investigator of the study, Professor Guy Magalon, M.D., Chief of the Division of Plastic Surgery and Professor of Universities, at H?pital de la Conception, AP-HM Marseille, France, at the 3rd Annual Cell Society Meeting.

As part of the study, 12 patients received an injection of Cytori's cell therapy into their fingers. The primary endpoints are safety, and the improvement in function of the hands, as measured by the Cochin hand functional scale at six months. At two month follow-up, the following outcomes were observed:

Primary

· No reports of infection, ischemic complications or serious adverse events;

· Significant improvement in the Cochin hand function disability scale (48.5±10.8 to 25.5±16.5, p<0.001);

Secondary

· Significant improvement in hand pain, as measured by the visual analog pain scale (from 59.4±17.2 to 21.6±17.5, p<0.001);

· Significant improvement in scleroderma health assessment questionnaire score (p<0.001); and

· Significant improvement in Raynaud's Severity Score (p<0.001).

Scleroderma is a chronic autoimmune disorder that causes fibrosis of the skin, destructive changes in blood vessels and involvement of multiple organ systems as the result of an overproduction of collagen in the skin and vital organs. People suffering from scleroderma very often have disabling disease involving the hands. Scleroderma affects women four times more frequently than men and is typically detected between the ages of 40 and 50. The National Institute of Arthritis and Musculoskeletal and Skin Diseases estimates that the number of people in the United States with systemic sclerosis ranges from 40,000 to 165,000. A survey that included all scleroderma-related disorders, including Raynaud's phenomenon, suggested a number between 250,000 and 992,500.

The study was initiated in late 2012 under the approval from the French National Agency for the Safety of Medicines and Health Products (ANSM, formerly AFSSAPS). It was organized by a multidisciplinary team of researchers at H?pital de le Conception. The researchers include Professor Magalon, Professor Brigitte Granel, M.D., Department of Internal Medicine of North Hospital and Professor of Universities, Professor Florence Sabatier, M.D., Head of the Department of Cell Therapy, Julie Veran, Cell Manufacturing Manager, Laurent Giraudo, Laboratory Chief Assistant, and Laurent Arnaud, Cell Characterization, Cell Therapy Department. In addition, Aurelie Daumas, Chief Clinician Assistant from the Department of Internal Medicine, and Pierre Nguyen, M.D., Chief Clinician Assistant from the Department of Plastic & Reconstructive Surgery, supported implementation of the study. Per ANSM, the Department of Cell Therapy previously validated cell characterization, viability and reproducibility of Cytori's cell therapy, as processed by the Celution® System.

Best,
Megan

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Mail on initial Scleroderma results 20 Sep 2013 08:38 #874

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Hopefully news will be disseminated after the presentation today.

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Mail on initial Scleroderma results 20 Sep 2013 08:44 #875

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Just as a comment- you only see the words - "significant" and p< 0,001. Meaning with 12 patients- it works wonderful for a localized treatment. This is not systemic, but I believe it works there too.

Like I mentioned small number of patients but if you get statistical significance there- it means this will get fast track and what have you all over the world, except the US probably.

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Mail on initial Scleroderma results 20 Sep 2013 08:45 #876

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Scolederma and other autoimmune advocacy groups need to be made aware of these results.

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Mail on initial Scleroderma results 20 Sep 2013 08:49 #877

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Good results imho but zero funds to move it forward other than in France. Auto-immune would make a nice partnership.

At least the data was better than what we saw with leaky wee wee's imho...LOL :cool:

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Mail on initial Scleroderma results 20 Sep 2013 09:02 #878

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Hopefully news will be disseminated after the presentation today.


Yes- that is a possibility- I hope they do. :yep:

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Mail on initial Scleroderma results 20 Sep 2013 17:36 #879

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Excellent results in an orphan indication. :woohoo: No wonder the french authorities have proposed expanding the trial. :nice:
Hopefully they announce an additional trial design that caters to more systemic cases and not just the hands.

A statement concerning the expanded trial specifications are what is truly important and provides significant validation of governments commitment to fund this trial.

This initial data will have all scleroderma support groups clamoring for trials to be approved............. perhaps some of them may contribute to funding ............ certainly patient registries in this indication can have a significant impact in moving this treatment paradigm forward. It is also very significant that the treatment appears to provide tangible results so quickly. :happy: Potential partners cannot help but take notice of this development.
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Mail on initial Scleroderma results 25 Sep 2013 02:02 #881

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"Cytori distributed this mail to the shareholders, which was NOT (why not?) distributed to the usual news media"

The only reason I can think of is that they did not want to steal the researcher's thunder. At this time there is probably a lot of analysis being undertaken of the 6 month data and also of a possible? broader systemic effect in the patients. All this data analysis is being undertaken by the French ........ hopefully with the objective of funding a much larger study.

The data was probably given directly "only" to us as a "bone" as proof of the merit of the translational research efforts of independent researchers. This is unfortunate from a market and investment perspective. It is however important to keep the researchers and government authorities funding these efforts happy.

Hopefully we will soon have an announcement of the expanded scleroderma trial parameters. The data provided to date virtually assures that this trial goes forward ............ with very positive implications for a host of other autoimmune diseases.

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Mail on initial Scleroderma results 25 Sep 2013 13:36 #882

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The only reason I can think of is that they did not want to steal the researcher's thunder.


Maybe- these are 2 months follow up data, which he intends to present also at the European Cell Society meeting next month. Actually Guy Magalon is also at LinkedIn and he posted roughly the same stuff that I did in another group there. Actually there was some interesting info posted there- I will post that here tomorrow.

To me that means he does not mind publicity- and an announcement over the wires would have helped his cause (i.e. attendants at the meeting) and our cause I guess (PPS impact).

To be honest- in my opinion it is simply the usual quality Cytori IR- but one gets used to that. :cry:

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