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TOPIC: Miracle happened- ACT-OA trial completely enrolled

Miracle happened- ACT-OA trial completely enrolled 15 Jun 2015 07:18 #4669

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Within 5 months or so....whats happening??????? :yep:

06/15/2015
SAN DIEGO--(BUSINESS WIRE)-- Cytori Therapeutics (NASDAQ: CYTX) announced today that enrollment has been completed in its US Phase IIb Osteoarthritis trial. The ACT-OA trial is a double-blind randomized, placebo-controlled trial evaluating the safety, feasibility and dosing of intraarticular administration of Cytori’s ECCO-50 cellular therapeutic in patients with knee osteoarthritis. A total of 94 patients were enrolled as of June 12, 2015.
“Based on faster than anticipated enrollment, we now expect to have six month follow up data for review in Q1 2016. We are very encouraged by the rate of recruitment, which was completed months ahead of the original plan,” said Marc Hedrick, CEO and President, Cytori Therapeutics. “Based on 24 week follow-up outcomes, we will provide an update on the data and the Phase 3 design, including the size of the trial, cost and end points."

“The rate of enrollment and interest in the procedure is indicative of the overall medical need of a validated cell therapy or biologic approach to osteoarthritis. Not only has the enrollment rate exceeded our expectations, we have found that the clinical procedure characterized by tissue harvest, bedside autologous cellular therapeutic manufacture and therapeutic delivery was readily adapted to the day surgery setting without difficulty. In fact, one center in the study performed three procedures with a single Celution system,” said Dr. Brian Cole, a Principal Investigator of the ACT-OA trial, and Professor and Vice-Chairman, Department of Orthopedics, Department of Anatomy and Cell Biology, Section Head, Cartilage Restoration Center at Rush, Rush University Medical Center.

The availability of safety and efficacy data in Q1 2016 will lead to informed decisions and discussions with the FDA regarding the study design and size of an osteoarthritis Phase III program with Cytori Cell Therapy.

Osteoarthritis is a disease of the entire joint involving the cartilage, joint lining, ligaments, and underlying bone. The breakdown of tissue leads to pain, joint stiffness and reduced function. It is the most common form of arthritis and affects an estimated 26.9 million US adults.1 Current treatments include physical therapy, non-steroidal anti-inflammatory medications, viscosupplement injections, and total knee replacement. The American Academy of Orthopedic Surgeon’s guidelines for the treatment of osteoarthritis of the knee noted that there were few non-surgical treatments that could be recommended2, which highlights the potential for Cytori Cell Therapy to address a large inadequately addressed medical need.

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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:

Miracle happened- ACT-OA trial completely enrolled 15 Jun 2015 08:07 #4670

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Now that is REALLY good news. Time is of the essence with Cytori. I had always wondered why the timeline on the trial was so long. There is such a big demand for knee treatments and patients SHOULD have been lining up. Turns out they were. Good news in a ocean of ambivalence.

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Miracle happened- ACT-OA trial completely enrolled 15 Jun 2015 08:08 #4671

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This is very good news....while I was expecting to hear completion in the August call based on the demand we had heard about this is even faster than I hoped for and shows great demand imho. Now we need good efficacy and a partner !

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Miracle happened- ACT-OA trial completely enrolled 15 Jun 2015 08:45 #4672

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Truly excellent news. Quick enrollment in OA shows the huge demand for this product.

I believe the scleroderma trial can also be very quickly enrolled. Although the patient population is much smaller we have access to a large percentage of the specialist medical centers dealing with this condition. There can be no doubt that there will be/is huge demand for this trial by patients who have a desperate need to address the quality of life issues this condition poses.

Also of great significance is the relatively quick onset of a treatment effect. Hopefully we will not have to wait terribly long for this trial to also be enrolled.

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Miracle happened- ACT-OA trial completely enrolled 15 Jun 2015 19:10 #4675

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Truly, big, huge, awesome, great news... Let's see how long it's gonna take them to release the results... over/under 6/15/2016, anyone?



Also, awful timing again... Marc is so good at it, it's unreal. :KO:

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Miracle happened- ACT-OA trial completely enrolled 16 Jun 2015 07:19 #4676

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This is the first time Cytori has exceeded expectations on any front.

Turning to the STAR Trial, the expectations have been set that it will take one year to enroll all 80 patients. The company expanded the trial sites to 20 from 12. This move places additional "drug producing devices" in the field, but increases the amount of pre-trial paperwork. The actual treatment takes about two hours (90 minutes to get the cells and 30 minutes to inject them) per patient. If this was a shotgun start each trial site would have 90 days between patients. That is one hell of a lot of paperwork!! :bash: :bash: :bash:

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Miracle happened- ACT-OA trial completely enrolled 16 Jun 2015 08:37 #4677

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DOV....I guess we need to consider the reason for the 20 trial centers ?
Hopefully, STAR will be another UPOD case where they will again under promise and over deliver (the exact reverse of CC days)
We should also consider although there is a billion $ opportunity we don't know what % we can capture over the first few years post approval.

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Miracle happened- ACT-OA trial completely enrolled 16 Jun 2015 20:01 #4678

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WST, Your posting on Yahoo is a great one.

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