Welcome, Guest
Username: Password: Remember me
General
  • Page:
  • 1
  • 2

TOPIC: Hard Evidence for ADRCs on Erectile Dysfunction

Hard Evidence for ADRCs on Erectile Dysfunction 03 Feb 2016 06:24 #6173

  • Wall Street Titan
  • Wall Street Titan's Avatar Topic Author
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 899
  • Thank you received: 148
SAN DIEGO--(BUSINESS WIRE)-- Cytori Therapeutics, Inc.(CYTX) announced today the publication of the results of an investigator initiated Phase I clinical trial using Cytori Cell Therapy™ for the treatment of erectile dysfunction (ED) following radical prostatectomy (RP).

The open-label, single-arm study was conducted in Denmark and enrolled 17 patients who had undergone radical prostatectomy within 5-18 months prior to the study. To qualify for the study, patients were required to have not regained erectile function following surgery despite appropriate pharmacological intervention. All patients received a single intracavernous injection of Cytori Cell Therapy. There were no serious adverse effects reported at six months follow-up, and eight of the 17 patients recovered erectile function within three months of treatment. In the publication, the authors concluded their “…findings suggest that autologous, freshly isolated ADRCs are safe to use and possess potential efficacy in the treatment of ED after RP.”

A post-hoc analysis was performed in which patients were divided into those who were continent prior to treatment (11 patients) and those who were incontinent (6 patients). Of the 11 in the continent group, 8 (73%) recovered erectile function which remained improved at 6 months. None of the incontinent patients recovered function.

The international index of erectile function-5 score (IIEF) for continent men improved from 7 (baseline) to 17 units at 6 months (p=0.007). The erection hardness score (EHS) improved from 1 (baseline) to 3 units at 6 months (p=0.03). The IIEF and EHS did not improve in the incontinent group.

Dr. Martha Haahr, the lead investigator, stated, "We are very pleased with the results from our Phase 1 study. In this open-label trial, we saw a very good effect on erectile function. It is remarkable, especially as these men had previously seen no effect from traditional medical treatment and continue to have good erectile function after 6 months follow-up. This suggests the possibility of therapeutic options for patients suffering from erectile dysfunction from other causes. We are already planning a double-blind randomized follow-up study.”

This study, published in the journal EBioMedicine, was executed at the Odense University Hospital, Odense, Denmark, by Dr. Martha Haahr and colleagues. Further details can be found on clinicaltrials.gov (NCT02240823).

In addition to this study, Cytori Cell Therapy is currently being studied in the ADRESU trial in Japan for male urinary incontinence following prostatic surgery. This investigator initiated, phase III, multicenter, 45 patient trial of the ECCI-50 cellular therapeutic is based on promising pilot trial data published in the International Journal of Urology in 2014. Details of the pilot trial can be found on clinicaltrials.gov and the Japanese Ministry of Health Labour and Welfare website.

“This recent Danish trial coupled with the ADRESU incontinence trial and related clinical experience in Japan, provide evidence that Cytori Cell Therapy may be able to effectively target two common and important side effects of prostate surgery, incontinence and erectile dysfunction,” said Dr. Marc H. Hedrick, President and CEO of Cytori Therapeutics(CYTX). “In the future, data from these trials may provide a foundation for broader clinical use of our technology for other urologic diseases.”
The following user(s) said Thank You: fatboy

Please Log in or Create an account to join the conversation.

Hard Evidence for ADRCs on Erectile Dysfunction 03 Feb 2016 06:31 #6175

  • paul
  • paul's Avatar
  • Offline
  • Senior Boarder
  • Senior Boarder
  • Posts: 55
  • Thank you received: 6
Blockbuster indication!

Please Log in or Create an account to join the conversation.

Hard Evidence for ADRCs on Erectile Dysfunction 03 Feb 2016 07:39 #6176

  • fas
  • fas's Avatar
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3357
  • Thank you received: 1116
So - what is a intracavernous injection? - Wiki has the following

An intracavernous (or intracavernosal) injection is an injection into the base of the penis. This injection site is often used to administer medications to check for or treat erectile dysfunction in adult men (in e.g. combined intracavernous injection and stimulation test).[1] The more common medications administered in this manner include Caverject, Trimix (prostaglandin, papaverine, and phentolamine), Bimix (papaverine and phentolamine), and Quadmix (prostaglandin, papaverine, phentolamine, and either atropine or forskolin). These medications are all types of vasodilators and cause tumescence within 10-15 minutes. Common side effects include, but are not limited to, priapism, bruising, fibrosis, Peyronies, and pain.

Priapism is also often treated with intracavernous injections, usually with sympathomimetic vasoconstricting drugs like adrenaline or phenylephrine.

Please Log in or Create an account to join the conversation.

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:

Hard Evidence for ADRCs on Erectile Dysfunction 03 Feb 2016 07:49 #6177

  • fas
  • fas's Avatar
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3357
  • Thank you received: 1116
The record at clinicaltrials.gov has been there since June 2014 and none of us has ever found it.. :cry:

The link : HERE

Anyway- as I always have said- there are many many other indications and applications being developed and Hedrick will only tell us when something gets published.. :puke:

Please Log in or Create an account to join the conversation.

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:

Hard Evidence for ADRCs on Erectile Dysfunction 03 Feb 2016 07:55 #6178

  • fas
  • fas's Avatar
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3357
  • Thank you received: 1116
So - the study indicates that men treated who were incontinent did not regain their erectile function.

I guess that means they have a major issue with their sphincter which prevents erections?

Anybody can shed light on this?

Please Log in or Create an account to join the conversation.

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:

Hard Evidence for ADRCs on Erectile Dysfunction 03 Feb 2016 08:20 #6181

  • myownhedgefund
  • myownhedgefund's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 2860
  • Thank you received: 204
I guess a interesting follow-up would be a ADRC incontinence treatment followed by a erectile dysfunction treatment

Please Log in or Create an account to join the conversation.

Hard Evidence for ADRCs on Erectile Dysfunction 03 Feb 2016 08:37 #6184

  • Wall Street Titan
  • Wall Street Titan's Avatar Topic Author
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 899
  • Thank you received: 148
From a clinical trial perspective the exclusion of UI patients is very valuable information in designing a Phase III trial. http://www.pcf.org/site/c.leJRIROrEpH/b.5836625/k.75D7/Erectile_Dysfunction.htm We've always felt confident in efficacy in multiple indications.

Please Log in or Create an account to join the conversation.

Hard Evidence for ADRCs on Erectile Dysfunction 03 Feb 2016 10:04 #6185

  • fatboy
  • fatboy's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 416
  • Thank you received: 77

Hard Evidence


WST,

I love it. You made me laugh. Thanks :grin:
The following user(s) said Thank You: Joncon63

Please Log in or Create an account to join the conversation.

Hard Evidence for ADRCs on Erectile Dysfunction 03 Feb 2016 10:32 #6187

  • Wall Street Titan
  • Wall Street Titan's Avatar Topic Author
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 899
  • Thank you received: 148
We need a good laugh. I think you are the only one who caught that. LOL

Please Log in or Create an account to join the conversation.

Hard Evidence for ADRCs on Erectile Dysfunction 03 Feb 2016 10:42 #6189

  • myownhedgefund
  • myownhedgefund's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 2860
  • Thank you received: 204
I noticed WST....good pun but phase 1 isn't hard news imho.
Nice they are moving forward with phase 2 and maybe we get more color in March call.

OA OA OA !!! This is what we really need.
Maybe Monday ?

Please Log in or Create an account to join the conversation.

Hard Evidence for ADRCs on Erectile Dysfunction 03 Feb 2016 13:49 #6192

  • Wall Street Titan
  • Wall Street Titan's Avatar Topic Author
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 899
  • Thank you received: 148
Yes Hedge, its only a Phase I but the results were impressive and it just adds to the evidence that ADRCs work.

Please Log in or Create an account to join the conversation.

Hard Evidence for ADRCs on Erectile Dysfunction 03 Feb 2016 14:55 #6194

  • Wall Street Titan
  • Wall Street Titan's Avatar Topic Author
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 899
  • Thank you received: 148
Excerpt from Study:

Our results hold promise for the outcome of other ongoing clinical
trials with stem cells for ED therapy, especially one trial in RP patients
using allogeneic cultured stem cells derived from bone marrow
(NCT01983709), and for tests of mesenchymal stem cells in a wide
range of human diseases. For evaluation of the clinical impact, it will
be important to characterize the quality, stability and potency of different
types and preparations of mesenchymal stem cells. For instance, it is
not known if cultured ADRCs or ADRCs from another person, other mesenchymal
stem cells or even induced pluripotent stem (iPS) cells would
work as well as the freshly isolated stem cells used herein. If cultured
non-autologous ADRCs or iPS cells work equally well both from a safety
and efficacy point of view, this would have a large impact for the field
since cells from stem cell banks could then be used. We investigated
ED after RP, which is considered a severe form of ED with nerve injury;
however, it is not known if stem cell therapy would work in patients
with ED due to diabetes, cardiovascular disease, lower urinary tract
diseases or simply age. Our results as well as results from the Korean
study in diabetic men (Bahk et al., 2010) suggest that stem cell therapy
may be effective for different types of ED.

Please Log in or Create an account to join the conversation.

Hard Evidence for ADRCs on Erectile Dysfunction 03 Feb 2016 18:32 #6195

  • DOV
  • DOV's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 347
  • Thank you received: 194
WST,

As you have long maintained, it is a battle between autologous and allogenic potency. Cytori has not been able to get a pharmaceutical company to support the autologous business model of manufacturing the drug at the bedside. You have been spot on here and it is clear that any partner Cytori might get will likely be a medical device company. Cytori is caught in the middle being a medical device company that manufacturers a drug rather than a stent or a pacemaker or a joint replacement.

As long as the CytoriCell Therapies work as well as we think they work, we should see daylight at some point.

Please Log in or Create an account to join the conversation.

Hard Evidence for ADRCs on Erectile Dysfunction 03 Feb 2016 20:05 #6196

  • myownhedgefund
  • myownhedgefund's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 2860
  • Thank you received: 204
Biotech in general has been getting creamed the last few weeks with drug pricing being a large part of the problem. This should play right into Cytori's hands someday but we are still playing with the viability of the company vs the viability of the cells.

:cry: :bash:

Please Log in or Create an account to join the conversation.

Hard Evidence for ADRCs on Erectile Dysfunction 03 Feb 2016 20:24 #6197

  • CalhounDoppelganger
  • CalhounDoppelganger's Avatar
  • Offline
  • Gold Boarder
  • Gold Boarder
  • Posts: 160
  • Thank you received: 20
once the trifecta hits, we'll be looking back on these days and laughing .

BARDA
SCLERODERMA
[insert any other application here......]

Please Log in or Create an account to join the conversation.

Hard Evidence for ADRCs on Erectile Dysfunction 03 Feb 2016 21:11 #6199

  • Wall Street Titan
  • Wall Street Titan's Avatar Topic Author
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 899
  • Thank you received: 148
DOV, you are correct but I thought that Cytori's head start, higher likelihood of efficacy, easier path to FDA approval and low COGS would give them a great shot of getting a head start to approvals. However, if you have two equally efficacious autologous and allogeneic therapies, Cytori will need a much lower COGS to make up for the need for a lipo and all the costs and additional risks that go along with with it.

Please Log in or Create an account to join the conversation.

Hard Evidence for ADRCs on Erectile Dysfunction 04 Feb 2016 10:23 #6201

  • fatboy
  • fatboy's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 416
  • Thank you received: 77
WST wrote

if you have two equally efficacious autologous and allogeneic therapies


The safety of autologous cells has always been an important factor to me. Having ones own cells re-introduced into ones body has to be safer than introducing a manufactured substance containing live cells.

Please Log in or Create an account to join the conversation.

Hard Evidence for ADRCs on Erectile Dysfunction 04 Feb 2016 10:49 #6202

  • Wall Street Titan
  • Wall Street Titan's Avatar Topic Author
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 899
  • Thank you received: 148
fatboy,

Having ones own cells re-introduced into ones body has to be safer than introducing a manufactured substance containing live cells.


I think that, in general, adult allogeneic stem cells have also been shown to be safe. It's going to come down to comparative efficacy, safety and COGS and some applications will be better suited to autologous, some maybe not. All the questions have not been answered yet but I think there is room for success both for those applications that get through the regulatory approval process.
The following user(s) said Thank You: fatboy

Please Log in or Create an account to join the conversation.

Hard Evidence for ADRCs on Erectile Dysfunction 04 Feb 2016 11:18 #6203

  • fatboy
  • fatboy's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 416
  • Thank you received: 77
WST,

I defer to your knowledge and agree that the efficacy issue is paramount. I guess it is just natural to believe that ones own cells are safer.

Nice article in SA by the way.

Please Log in or Create an account to join the conversation.

Hard Evidence for ADRCs on Erectile Dysfunction 05 Feb 2016 17:36 #6223

  • paul
  • paul's Avatar
  • Offline
  • Senior Boarder
  • Senior Boarder
  • Posts: 55
  • Thank you received: 6
I can say, having worked with the elderly for many years, that in my opinion the autologous cells are going to be accepted much more readily than allogeneic cells, at least at first.

Please Log in or Create an account to join the conversation.

  • Page:
  • 1
  • 2
Time to create page: 0.122 seconds

Copyright Information

Copyright Fas Kuiters © 2016 young-foxes.com. All Rights Reserved.
This page is made with Joomla CMS and its various templates designed by Fas Kuiters with the excellent Themler tool.

 

 

Shared Spreadsheet Links

DOV´s Revised Projections for the Periods 2017 until 2020

Shareble link : HERE

Fas Kuiters Websites