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TOPIC: ADRESU

ADRESU 28 Mar 2018 11:05 #11615

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Enrollment has been completed in the ADRESU trial for stress urinary incontinence. A total of 45 patients, all treated in Japan, were enrolled. See full release.

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ADRESU 28 Mar 2018 11:27 #11616

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A little bit overdue- but better late than never- :yep:

Enrollment Completed in ADRESU Clinical Trial of Cytori Cell Therapy™ for Stress Urinary Incontinence

Mar 28, 2018
SAN DIEGO and TOKYO, March 28, 2018 (GLOBE NEWSWIRE) -- Cytori Therapeutics, Inc. (NASDAQ:CYTX) announced today that full enrollment has been reached in the ADRESU investigator-initiated clinical trial of Cytori Cell Therapy™ for men with stress urinary incontinence as a complication of prostate intervention. A total of 45 patients, all treated in Japan, were enrolled in this potential approval trial.

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 Adipose Derived Regenerative Cells (ADRCs) and Adipose Cells. The ADRESU trial was based on a promising pilot trial with short-term data of 11 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.

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) at 52 weeks after treatment. A number of other key secondary endpoints are also being assessed. If the primary endpoint is successfully achieved, the data may be used to seek approval of ECCI-50 for this indication.

The trial costs are substantially supported by the Japan Agency for Medical Research and Development, an independent administrative agency of the Government of Japan, with additional support from Cytori. The trial is sponsored by the lead institution, Nagoya University.

“Cytori would like to thank the investigators and patients participating across the 4 sites involved in this clinical trial: Nagoya University, Shinshu University, Kanazawa University and Dokkyo University,” said Dr. Marc H. Hedrick, President and CEO of Cytori Therapeutics. “If the trial successfully meets key endpoints, Cytori intends to seek marketing approval and reimbursement for this cellular therapeutic product in Japan.”

Use of Cytori Cell Therapy™ is growing in Japan, primarily for aesthetic, breast and osteoarthritis indications. Japan’s groundbreaking Regenerative Medicine Law, enacted in November 2014, provides companies such as Cytori that offer regenerative medicine such as Cytori Cell Therapy, expedited pathways to the market. Since 2008, Cytori’s Japanese subsidiary has built an installed customer base of 77 centers using its regenerative medicine products and has shown double digit growth in utilization over the preceding 3 years.

“Prostatic disease, including prostate cancer and benign prostatic hyperplasia is very common among aging males,” said Dr. Momokazu Gotoh, Professor and Chairman of the Department of Urology at Nagoya University and Principal Investigator for the ADRESU trial. “Urinary incontinence, as a complication of prostatic intervention, is difficult to treat and limited treatment options are available. Most patients resort to wearing a diaper to manage the leakage. Cytori Cell Therapy would be the first approved therapy for this indication in Japan.”

About ADRESU Investigators
The ADRESU trial is being led by Dr. Momokazu Gotoh at Nagoya University, Aichi, Japan. The other participating investigators and institutes include Dr. Kazutaka Narimoto at Kanazawa University Hospital (Ishikawa, Japan), Dr. Osamu Ishizuka at Shinshu University Hospital (Nagano, Japan) and Dr. Tomonori Yamanashi at Dokkyo Medical University (Tochigi, Japan).

About Male Stress Urinary Incontinence
Male stress urinary incontinence is a post-surgical complication of radical prostatectomy and surgeries for benign prostatic hyperplasia with limited treatment options, representing an unmet medical need. In 2016, the Ministry of Health, Labor and Welfare (MHLW) reported approximately 20,000 prostate cancer surgeries and 22,000 benign prostatic hyperplasia procedures performed at Diagnostic Procedure Combination (DPC) participating hospitals.

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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:

ADRESU 28 Mar 2018 11:53 #11617

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Fas, I would think that meeting the endpoints s/b very likely based on the two prior pilot trials - what odds do you give it?

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ADRESU 28 Mar 2018 13:06 #11618

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rodney.strongg wrote: Fas, I would think that meeting the endpoints s/b very likely based on the two prior pilot trials - what odds do you give it?


I am clueless as to the chances of meeting the end-points. What I like about it that it is measurable and factual. No subjective patient questionaires, but straight forward facts in an open clinic. We will see- in the past I read a lot about Gotoh and Yamamoto both from Nagoya. Their credentials are excellent - I trust they want the app to be a success, like it probably will be, since Cytori did not touch it.:grin:

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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:

ADRESU 28 Mar 2018 13:16 #11619

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fas wrote:

rodney.strongg wrote: Fas, I would think that meeting the endpoints s/b very likely based on the two prior pilot trials - what odds do you give it?


I am clueless as to the chances of meeting the end-points. What I like about it that it is measurable and factual. No subjective patient questionaires, but straight forward facts in an open clinic. We will see- in the past I read a lot about Gotoh and Yamamoto both from Nagoya. Their credentials are excellent - I trust they want the app to be a success, like it probably will be, since Cytori did not touch it.:grin:


It's not costing CYTX any money and the results s/b known in a year - you would think that this would be easily partnerable and bring in some much needed cash - without the pressure of another imminent raise, the stock is easily over $1 imo.

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ADRESU 29 Mar 2018 09:28 #11620

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rodney.strongg wrote:

fas wrote:

rodney.strongg wrote: Fas, I would think that meeting the endpoints s/b very likely based on the two prior pilot trials - what odds do you give it?


I am clueless as to the chances of meeting the end-points. What I like about it that it is measurable and factual. No subjective patient questionaires, but straight forward facts in an open clinic. We will see- in the past I read a lot about Gotoh and Yamamoto both from Nagoya. Their credentials are excellent - I trust they want the app to be a success, like it probably will be, since Cytori did not touch it.:grin:


It's not costing CYTX any money and the results s/b known in a year - you would think that this would be easily partnerable and bring in some much needed cash - without the pressure of another imminent raise, the stock is easily over $1 imo.


One would believe so Rod but there seems to be powers to be that are manipulating this to keep it beaten down to pick it up for a song just prior to them hitting pay dirt.
I see another RS coming which will screw us. Timing is everything and for those buying in after another RS, it could be a golden opportunity. Long term holders here have helped to keep this company going for years but the new buyers in around the EOY could be the ones to really score.

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ADRESU 29 Mar 2018 10:51 #11621

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b7
***One would believe so Rod but there seems to be powers to be that are manipulating this to keep it beaten down to pick it up for a song just prior to them hitting pay dirt.***
Company doing a fine job all by themselves in destroying the PPS.

***I see another RS coming which will screw us.***
Clearly, and forewarned some time ago. Coming sooner than most expect as well.

***Timing is everything and for those buying in after another RS, it could be a golden opportunity. Long term holders here have helped to keep this company going for years but the new buyers in around the EOY could be the ones to really score. ***

Maybe. A better description imho would be that a decent opp. may present after the next secondary that something positive happens on the Azaya assets front. Still full of risk .
It would likely be best just to trade it.

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ADRESU 29 Mar 2018 15:57 #11622

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“It would likely be best just to trade it.”

Like most of the long timers here, in too deep. Should of thought of this prior to the first RO.
You’re right, short of a savior, RS again on the way but that plays right into the company’s playbook doesn’t it? RS to get the pps back into the $3.50 range allows them to use the Lincoln ATM, am I wrong?
Management could care less about the long time holders value, despite keeping them in their luxury salaries and keeping the company afloat. They are obviously waiting for some clear direction up as evident by their lack of insider buying but hey, they do have their multiple stock options to sit on.

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ADRESU 29 Mar 2018 17:31 #11623

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the problem with the Lincoln Park ATM is the market cap more so than the PPS.
Under the terms of the deal they simply cant sell enough shares. I did post the details somewhere not all that long ago in the lodge.
Anyway....It will likely be either a offering with full common stock or with convertible preferred. This will be discounted appropriately of course.
Less likely is some new form of a debt deal that basically mortgages it all for one last throw of the dice....such a deal would have to take care of existing loan terms.
This will all have to come about this summer....most think they have until Sept. 4 for the R/S but the cash issue comes up before then and there is no solving that until the PPS is fixed...ie R/S !!!!
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