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TOPIC: Sustained benefit reported in ED with CCT

Sustained benefit reported in ED with CCT 09 Jul 2018 01:06 #12025

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The folks at Callan Road are still at work at 9.00 pm PDT on Sunday- I did expect something different from them though...:whistle:

Jul 09, 2018
Benefit Observed at 12 months Postoperatively Following Single Administration
SAN DIEGO, July 09, 2018 (GLOBE NEWSWIRE) -- Cytori Therapeutics, Inc. (Nasdaq:CYTX) announced publication in the peer-reviewed journal, Urology, of “A 12-Month Follow-up After a Single Intracavernous Injection of Autologous Adipose-derived Regenerative Cells in Patients with Erectile Dysfunction Following Radical Prostatectomy: An Open-label Phase I Clinical Trial”.

The trial of Adipose-Derived Regenerative Cells (ADRCs) or Cytori Cell Therapy™ in erectile dysfunction (ED) following radical prostatectomy was performed by investigators from the Danish Centre for Regenerative Medicine and Odense University Hospital, Odense, Denmark.

In the trial, 21 patients with ED after radical prostatectomy (RP), with no signs of recovery following conventional therapy, received a single intra-cavernous injection of autologous ADRCs. Six men were incontinent, and 15 were continent at inclusion. Safety and efficacy (sexual function) were evaluated over 12 months through assessment of adverse events and use of validated questionnaires including the International Index of Erectile Function-5 (IIEF-5) and Erection Hardness Score (EHS).

The mean age at baseline was 60.2 years (range 46-69). The approach was deemed safe with no serious adverse events reported. At 12 months following treatment with cell therapy, erectile function assessed using the IIEF-5 showed a statistically significant improvement from a median baseline score of six to a median of eight; p=0.004. Subset analysis of the 15 patients with urinary continence at baseline, showed substantially greater improvement from a median baseline score of six to 13; p=0.012.

At 12 months after surgery, median EHS was unchanged in the combined group of 21 patients. However, patients in the continent subset exhibited statistically significant improvement in EHS from a baseline median score of one to a median of two at 12 months; p=0.03. Further, 53.3% or eight out of 15 continent patients reported recovered function sufficient for completion of intercourse.

ED and urinary incontinence are serious issues for many men following RP. Cytori Cell Therapy™ is being used to address both of these medical problems. Thus, in addition to the work published in this report, the company has fully enrolled the Autologus Aipose Derived Regenerative Cells for the Treatment of Male Stress Urinary Incontinence (ADRESU) trial of Cytori Cell Therapy™ in men with stress urinary incontinence following RP. The primary endpoint for the ADRESU trial is the percentage of patients who experience greater than 50% reduction in urinary leakage volume from baseline (as measured by the weight of unintended urinary leakage over 24 hours) one year following treatment. Data from ADRESU are anticipated in the first half of 2019.

ADRESU is an investigator-initiated, multicenter, 45 patient, open-label, single arm clinical trial of Cytori’s ECCI-50 cellular therapeutic, comprised of Celution®-prepared autologous ADRCs and Adipose Cells. The ADRESU trial was based on a promising pilot trial with short-term data of eleven patients published in the International Journal of Urology in 2014 and long-term data of 14 patients presented at the International Continence Society in 2017, which “demonstrated that transurethral injection of autologous ADRCs can be a safe and effective treatment modality for postprostatectomy incontinence”. Details of the ADRESU protocol and trial can be found on BMC Urology, clinicaltrials.gov and the University Hospital Medical Information Network website.

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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:

Sustained benefit reported in ED with CCT 09 Jul 2018 05:56 #12026

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fas wrote: The folks at Callan Road are still at work at 9.00 pm PDT on Sunday- I did expect something different from them though...:whistle:

Jul 09, 2018
Benefit Observed at 12 months Postoperatively Following Single Administration
SAN DIEGO, July 09, 2018 (GLOBE NEWSWIRE) -- Cytori Therapeutics, Inc. (Nasdaq:CYTX) announced publication in the peer-reviewed journal, Urology, of “A 12-Month Follow-up After a Single Intracavernous Injection of Autologous Adipose-derived Regenerative Cells in Patients with Erectile Dysfunction Following Radical Prostatectomy: An Open-label Phase I Clinical Trial”.

The trial of Adipose-Derived Regenerative Cells (ADRCs) or Cytori Cell Therapy™ in erectile dysfunction (ED) following radical prostatectomy was performed by investigators from the Danish Centre for Regenerative Medicine and Odense University Hospital, Odense, Denmark.

In the trial, 21 patients with ED after radical prostatectomy (RP), with no signs of recovery following conventional therapy, received a single intra-cavernous injection of autologous ADRCs. Six men were incontinent, and 15 were continent at inclusion. Safety and efficacy (sexual function) were evaluated over 12 months through assessment of adverse events and use of validated questionnaires including the International Index of Erectile Function-5 (IIEF-5) and Erection Hardness Score (EHS).

The mean age at baseline was 60.2 years (range 46-69). The approach was deemed safe with no serious adverse events reported. At 12 months following treatment with cell therapy, erectile function assessed using the IIEF-5 showed a statistically significant improvement from a median baseline score of six to a median of eight; p=0.004. Subset analysis of the 15 patients with urinary continence at baseline, showed substantially greater improvement from a median baseline score of six to 13; p=0.012.

At 12 months after surgery, median EHS was unchanged in the combined group of 21 patients. However, patients in the continent subset exhibited statistically significant improvement in EHS from a baseline median score of one to a median of two at 12 months; p=0.03. Further, 53.3% or eight out of 15 continent patients reported recovered function sufficient for completion of intercourse.

ED and urinary incontinence are serious issues for many men following RP. Cytori Cell Therapy™ is being used to address both of these medical problems. Thus, in addition to the work published in this report, the company has fully enrolled the Autologus Aipose Derived Regenerative Cells for the Treatment of Male Stress Urinary Incontinence (ADRESU) trial of Cytori Cell Therapy™ in men with stress urinary incontinence following RP. The primary endpoint for the ADRESU trial is the percentage of patients who experience greater than 50% reduction in urinary leakage volume from baseline (as measured by the weight of unintended urinary leakage over 24 hours) one year following treatment. Data from ADRESU are anticipated in the first half of 2019.

ADRESU is an investigator-initiated, multicenter, 45 patient, open-label, single arm clinical trial of Cytori’s ECCI-50 cellular therapeutic, comprised of Celution®-prepared autologous ADRCs and Adipose Cells. The ADRESU trial was based on a promising pilot trial with short-term data of eleven patients published in the International Journal of Urology in 2014 and long-term data of 14 patients presented at the International Continence Society in 2017, which “demonstrated that transurethral injection of autologous ADRCs can be a safe and effective treatment modality for postprostatectomy incontinence”. Details of the ADRESU protocol and trial can be found on BMC Urology, clinicaltrials.gov and the University Hospital Medical Information Network website.

/


I was just going to post the news - will be interesting to see how much in near-term SP this news will be worth given the current state of affairs at CYTX!

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Sustained benefit reported in ED with CCT 09 Jul 2018 08:13 #12028

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Ok, so where does this lead us Fas, could a Danish study lead into EU approval?

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Sustained benefit reported in ED with CCT 09 Jul 2018 08:40 #12029

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b767cpt wrote: Ok, so where does this lead us Fas, could a Danish study lead into EU approval?

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Sustained benefit reported in ED with CCT 09 Jul 2018 09:43 #12030

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b767cpt wrote: Ok, so where does this lead us Fas, could a Danish study lead into EU approval?


Both this study- ED following prostatectomy and another very interesting study on lymphedemia after breast cancer treatment fall in the category of follow-up treatment of cancer patients i.e. oncology. Both have been done by the same Danish group.
Cytori is also looking for a marketing partner for ATI-0918 in Europe, so all in all , one could see this as a package, if you like, which could interest a player in the field of oncology. But of course before that EMA approval is required. I would guess for both apps a 40- 80 patient pivotal study is required that need to be funded by a partner. Both are unmet needs.
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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:

Sustained benefit reported in ED with CCT 09 Jul 2018 10:06 #12031

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fas wrote:

b767cpt wrote: Ok, so where does this lead us Fas, could a Danish study lead into EU approval?


Both this study- ED following prostatectomy and another very interesting study on lymphedemia after breast cancer treatment fall in the category of follow-up treatment of cancer patients i.e. oncology. Both have been done by the same Danish group.
Cytori is also looking for a marketing partner for ATI-0918 in Europe, so all in all , one could see this as a package, if you like, which could interest a player in the field of oncology. But of course before that EMA approval is required. I would guess for both apps a 40- 80 patient pivotal study is required that need to be funded by a partner. Both are unmet needs.

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Sustained benefit reported in ED with CCT 10 Jul 2018 20:54 #12042

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The is a slow and early movement currently occurring banning plastic straws in the USA.
What will Cytori have to offer then ? :evil: :whistle:

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