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TOPIC: First patient enrolled in ADRESU (SUI Nagoya)

First patient enrolled in ADRESU (SUI Nagoya) 03 Sep 2015 06:11 #5131

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SAN DIEGO--(BUSINESS WIRE)-- Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced that the first patient has been enrolled and treated in the ADRESU trial, a late phase, physician-initiated Japanese clinical trial to study the efficacy and safety of Cytori Cell Therapy™ in men with urinary incontinence after prostatic surgery for prostate cancer or benign prostatic hypertrophy.

ADRESU is a multicenter, 45 patient open label controlled trial of the ECCI-50 cellular therapeutic and 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 MHLW website. The primary endpoint for the ADRESU trial will be the number of patients who experience reduction of urinary leakage volume (as measured by the weight of diaper pads used over 24 hours) 52 weeks after treatment. If the endpoint is successfully achieved, the data will be used to seek approval of Cytori Cell Therapy for this indication. The trial costs are substantially supported by Japan’s Ministry of Health, Labour and Welfare, with additional support by Cytori. The trial is sponsored by Nagoya University.

“Cytori is committed to the goal of obtaining the first approval for a cellular therapeutic product since the new Regenerative Medicine Law was implemented in November 2014,” said Dr. Marc H. Hedrick, President and CEO of Cytori Therapeutics. “The administration of Prime Minister Abe has made a substantial commitment of Japanese resources to this field and we feel likewise committed to this important market.”

Cytori has been commercially active in the Japanese market since 2008 through its Japanese subsidiary and has had a full-time office and in-country leadership in Japan since 2005. Over that period of time, Cytori has built a user base of approximately 50 sites, including both hospitals and individual clinics. Many users are in leading academic institutions throughout Japan, such as Nagoya University.

Dr. Momokazu Gotoh, Professor and Chairman of the Department of Urology at Nagoya University and Principal Investigator on the ADRESU trial, said, “Prostatic disease is a very common cancer in aging males. Incontinence after prostatic manipulation or surgery is notoriously hard to treat and physicians have little to offer these patients beyond adult diapers and psychological support. Cytori Cell Therapy technology performed well in the pilot trial and holds promise as an effective therapy for this indication.”

The ADRESU trial was based on preliminary safety and efficacy data published in 2014 in the International Journal of Urology. Following enrollment and assessment of the results of the trial, Cytori and Nagoya University intend to file for medical device approval for the therapy, which in Japan is typically combined with reimbursement.

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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:

First patient enrolled in ADRESU (SUI Nagoya) 03 Sep 2015 08:22 #5133

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So now they have 2 Phase III's in enrollment and one Phase II where enrollment is complete yet the market cap hovers well below $100 million. This SUI trial is a sweet deal in that it is financed my the same Japanese government that will be determining whether the results warrant approval and reimbursement. All good news and looks like Cytori will no be trying to explain the value that is being created:

Company invites individual and institutional investors as well as advisors to attend and ask questions at VirtualInvestorConferences.com

SAN DIEGO, Sept. 3, 2015 /PRNewswire/ -- Cytori Therapeutics Inc.(CYTX) , today announced that President and CEO Marc Hedrick, M.D. will present live at VirtualInvestorConferences.com on September 10, 2015.

DATE: Thursday, September 10, 2015
TIME: 1 pm ET
LINK: tinyurl.com/sep10pre

This will be a live, interactive online event where investors are invited to ask the company questions in real-time – both in the presentation hall as well as the association's "virtual trade booth." If attendees are not able to join the event live on the day of the conference, an on-demand archive will be available for 90 days.

It is recommended that investors pre-register to save time and receive event updates.

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Enrollment began and first patient has been treated in ADRESU Japanese urinary incontinence approval trial
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Cytori reported its Licensee, Kerastem Technologies, received conditional approval from FDA for a Phase II Alopecia Trial
Cytori completed enrollment of US Phase IIb Osteoarthritis Trial, ACT-OA trial, 6-month data expected in Q1 2016
Celution processed adipose derived cell therapy was granted orphan drug status for treatment of scleroderma in European Union
Cytori reported positive topline 12-month follow-up data on SCLERADEC-I Trial
Cytori and Lorem Vascular were granted regulatory clearance for Cytori Celution® System by the State Food and Drug Administration of the People's Republic of China, and initial purchase order placed by Lorem Vascular
Learn more about the event: www.virtualinvestorconferences.com

About Cytori Therapeutics(CYTX)
Cytori Therapeutics (CYTX) is a late stage cell therapy company developing autologous cell therapies from adipose tissue to treat a variety of medical conditions. Data from preclinical studies and clinical trials suggest that Cytori Cell Therapy™ acts principally by improving blood flow, modulating the immune system, and facilitating wound repair. As a result, Cytori Cell Therapy™ may provide benefits across multiple disease states and can be made available to the physician and patient at the point-of-care through Cytori's proprietary technologies and products. For more information: visit www.cytori.com

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