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TOPIC: Scleroderma Pivotal Clinical Trial FDA Green Light

Scleroderma Pivotal Clinical Trial FDA Green Light 10 Dec 2014 07:34 #2880

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FDA Grants Cytori Conditional Approval for a U.S. Pivotal Clinical Trial in Scleroderma
Business Wire Cytori Therapeutics, Inc.


SAN DIEGO--(BUSINESS WIRE)--

Cytori Therapeutics, Inc. (CYTX) today announced that the U.S. Food and Drug Administration (FDA) has granted conditional approval for an Investigational Device Exemption (IDE) for a pivotal clinical trial, named the ‘STAR’ trial, to evaluate Cytori Cell Therapy™ as a potential treatment for impaired hand function in scleroderma, a rare autoimmune disease affecting approximately 50,000 patients in the United States.

The STAR trial is conditionally approved to be a randomized, double blind, placebo-controlled pivotal clinical trial of 80 patients in up to 12 U.S. sites. The trial evaluates the safety and efficacy of a single administration of Cytori Cell Therapy in scleroderma patients affecting the hands and fingers. More than 90 percent of scleroderma patients have hand involvement that is typically progressive and can result in chronic pain, blood flow changes and severe dysfunction. The limited available treatments for scleroderma may provide some benefit but do little to modify disease progression or substantially improve symptoms.

Cytori’s cell therapy processing technology, known as the Celution® System, is regulated as a Class III medical device by the U.S. FDA and requires a successful pivotal trial and premarket authorization (PMA) before it can be marketed in the United States. The Celution System produces an autologous cell product from adipose tissue known as adipose-derived regenerative cells (ADRCs™).

The STAR trial is predicated on a completed pilot trial, SCLERADEC-I. In data presented earlier this year, patients in SCLERADEC-I showed, on average, 50 percent improvement at six months across four important and validated endpoints used to assess the clinical status in patients with systemic scleroderma with impaired hand function. This data was published in the Annals of the Rheumatic Diseases in May 2014.

“Hand problems from scleroderma result in substantial distress, pain and impaired quality of life. We need more effective therapeutic options for our patients. I was impressed by the single center French study with Celution processed adipose-derived regenerative cells in patients with scleroderma hand disability, and although it is limited by a small number of patients, it provides the data to support the larger, well-designed, randomized, controlled trial that we will be conducting,” said Dr. Dinesh Khanna, Director, University of Michigan Scleroderma Program and a principal investigator of the STAR trial.

The STAR trial plans to use the Cochin hand score, a validated measure of hand function, as the primary endpoint measured at 6 months after a single administration of Cytori Cell Therapy or placebo. Patients in the placebo group will be eligible for crossover to the active arm of the trial after all patients have completed 12 months of follow up. Additional details about the trial will be disclosed once finalized and agreement is reached with the FDA. The trial is anticipated to begin enrollment in 2015.

“The STAR trial is a direct result of our new strategy to focus on identifying innovative, later stage therapeutic applications and moving the most promising into the clinic. We are hopeful that this trial will show data consistent with the efficacy signal observed in the recently published trial,” said Dr. Marc Hedrick, President and CEO of Cytori. “Additionally, the rare nature of scleroderma-associated hand involvement represents a potential straightforward and targeted path to market and reimbursement following the pivotal clinical trial.”

Cytori’s management team will host an informational meeting with a Q&A period regarding the STAR trial during the J.P. Morgan Healthcare Conference on January 12-15 in San Francisco. Additional details will be provided in a press release later in December.

About Scleroderma

Scleroderma is a chronic autoimmune disorder associated with fibrosis of the skin, destructive changes in blood vessels and multiple organ systems as the result of a generalized overproduction of collagen. Scleroderma affects women four times more frequently than men and is typically detected between the ages of 30 and 50. Most people suffering from scleroderma have disabling disease involving the hands. The National Institute of Arthritis and Musculoskeletal and Skin Diseases estimates that the number of people in the United States with systemic sclerosis is approximately 50,000.1,2 Treatment options are directed at protecting the hands from injury and detrimental environmental conditions as well as the use of vasodilators. When the disease is advanced, immunosuppressive and other medications may be used but are often accompanied by intolerable side effects.

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Scleroderma Pivotal Clinical Trial FDA Green Light 10 Dec 2014 08:00 #2881

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This is the first substantive piece of good news in a while. I wrote an article on this over a year ago. What is even more encouraging is what I've been hearing about how well Okyanos is doing and what it could mean for KT Lim in China and his other marketing areas. I can't really guess on the timing of a Lorem ramp up but if you extrapolate from what I'm hearing about Okyanos, the numbers get huge in a hurry.



To Roth, before you get started, I'm not hyping here just sharing my thoughts.
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Scleroderma Pivotal Clinical Trial FDA Green Light 10 Dec 2014 08:08 #2882

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besides being good news, advances are made in the quality of communication-

Cytori’s cell therapy processing technology, known as the Celution® System, is regulated as a Class III medical device by the U.S. FDA and requires a successful pivotal trial and premarket authorization (PMA) before it can be marketed in the United States. The Celution System produces an autologous cell product from adipose tissue known as adipose-derived regenerative cells (ADRCs™).


This is the first time (ever) that Cytori properly states that Celution is a CLASS III device in the US and does not speak of "Phase II" data, but of either a PILOT clinic or PIVOTAL clinic. Since the FDA apparently accepted SCLERADEC-I as the pilot (which was the CC "strategy" in the first place), at the end of the clinic, which is really "low hanging fruit" reimbursement in the US should be possible.

Well done- the other thing I like is the cross-over at 12 months. maybe the Cytori medical folks are finally showing some humanity?
Bout time... :evil: :evil:
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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:

Scleroderma Pivotal Clinical Trial FDA Green Light 10 Dec 2014 08:17 #2883

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It sure seems to be all about patients Fas. One Day.................It might very well pay......... :vegas:

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Scleroderma Pivotal Clinical Trial FDA Green Light 10 Dec 2014 08:36 #2884

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People may not know that the IDE is being accepted or granted based partly on the EU data (EU pilot trial). The new U of Michigan trial is not a pilot trial; it is pivotal-meaning PMA is on the way. The data from the EU trial has to be well documented per Good Clinical Practice, before FDA would accept the data as part of the IDE. The data must be good, before Dr. Khanna would become the Principle Investigator.

My family all are related to U. of Michigan and we are proud to have Michigan involved in this pivotal trial (my son is a professor in the School of Engineering).

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Scleroderma Pivotal Clinical Trial FDA Green Light 10 Dec 2014 08:43 #2885

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Certainly a positive for a indication where help is rare.

Of course, we still need funds to pay for this trial .

The other positive is the FDA finally seems to be moving in a manner where investigations can prove therapies for patients ! A shock in itself.

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Scleroderma Pivotal Clinical Trial FDA Green Light 10 Dec 2014 09:17 #2886

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How much is it going to cost to get the ball over the finish line?
It’s not clear how this study will be funded….more loan sharks? Maybe Marc & Company can get funding through the Shark Tank series. Who knows we might even get a better deal than the last one and our share price might actually move the needle over a buck!
Don’t get me wrong I’m actually very excited about our prospects. Nothing worse than finding a gold mine but can’t afford the shovel & pick to extract the gold. Forced to get a loan for the shovel & pick at 50% of the value of the gold mine is not a good investment unless there’s lots and lots of gold.
Hope springs eternal…

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Scleroderma Pivotal Clinical Trial FDA Green Light 10 Dec 2014 09:20 #2887

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I was reading up a bit on Dr. Khanna (who originally comes from New delhi, India) and started listening to a presentation he made.

But I did also view this video from the Scleroderma Foundation- Its excellent and only 10 minutes, well worth spending that time !!!!




The message is clear- the patients want their hands back..
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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:

Scleroderma Pivotal Clinical Trial FDA Green Light 10 Dec 2014 10:32 #2890

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Fas,

"Well done- the other thing I like is the cross-over at 12 months. maybe the Cytori medical folks are finally showing some humanity?"

Unfortunately, Cytori cannot afford humanity. This is more about accelerating the recruitment numbers. Offering free treatment is a big incentive to getting patients interested.

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Scleroderma Pivotal Clinical Trial FDA Green Light 10 Dec 2014 10:40 #2891

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FAS,
I pray that the application of stem cell technology can help these poor people. Autoimmune disease is a blight on humanity.

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Scleroderma Pivotal Clinical Trial FDA Green Light 10 Dec 2014 12:07 #2892

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Ray-

This is a bit of a complex theme. On the one side you are absolutely right. Patients -certainly the ones that can afford it- do not buy the shit of eternal placebo if it does not have to be and demand a cross-over. So you are left with patients that take the chance, because they do not have the money to go elsewhere, meaning outside the US.

I have been looking at this for years- Declaration of Helsinki and things, which are based on the MAIN PILLAR of "concern for the interests of the subject must always prevail over the interests of science and society"

This should be the DOGMA or simply the basis of all truth.

The US- or better the FDA- do not refer to this Declaration for very hippocratic reasons- due to inertia in applying so called "(us) standard of care" in placebo patients in underdeveloped nations, primarily during HIV research. However- in developed nations- not called the US, the "humanity" has prevailed a lot more evidently, especially in the "compassionate use" regulations.

Anyway- to make a long story short- in my view- the FDA and the Companies it deals with to guide therapies or drugs to the market, have abused the system .

PRECISE is a prime example- there are NO DATA period beyond 18 months data (even if a paper was issued which was totally embarrassing)- so it was never intended to collect LT data of mortality or whatever. All those patients AND the ones in ATHENA I and II should have been promised cross-over and things would have been better. I do not think that had anything to do with regulators in Europe but with Cytori and possibly discussions they had with FDA representatives. :bang: :bash:

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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:

Scleroderma Pivotal Clinical Trial FDA Green Light 10 Dec 2014 13:09 #2893

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They will have enough money to do this trial if the convertibles and warrants are exercised, and they will be. That's basically 16-20 million from the warrants (I'm not sure how many pre-October warrants there are) and 8.5 more from the convertibles. But it's heavy dilution, so the pick analogy stands.

If they can use the new systems that would be a plus....

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Scleroderma Pivotal Clinical Trial FDA Green Light 18 Dec 2014 12:32 #2938

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Hi fas (or shape),

i am new here. :bye:

I am a old member of the young foxes group. :happy:

I buy today some shares of cytory after reading very carefully all the stuff. :nice:

Tow days ago i hear the song "stairway to heaven" in the radio, i think that was a sign...

holdi

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holdi

Scleroderma Pivotal Clinical Trial FDA Green Light 18 Dec 2014 12:50 #2940

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Welcome back Holdi.

Mind you, Cytori is just something for die-hards, visionaries and folks that appear to understand.

Lets hope- we do and hope the management finally can turn things around... :bye:

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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:

Scleroderma Pivotal Clinical Trial FDA Green Light 18 Dec 2014 14:39 #2944

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they will understand, but only numbers (easy everbody understand), partners (because they don´t understand)

and the new management we should get them a second chance..

i love the step by step approach, first "low hanging fuits" and then a little bit more...

this tech for 50 Mio market cap ??? a little bit to sheap...

step by step they must generate revenue, it will come, i am confident (as the confidence is broken)

holdi

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holdi

Scleroderma Pivotal Clinical Trial FDA Green Light 19 Dec 2014 08:14 #2951

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Cytori´s news flow start to be impressive...

Cytori Therapeutics, Inc. (CYTX) announces it will be hosting an information session dedicated to its planned STAR pivotal trial and scleroderma, featuring principal investigator Dr. Dinesh Khanna. The session will be held on January 14, 2015, from 1:30 PM to 4:30 PM at the Prescott Hotel, 545 Post Street, San Francisco, Room 736.
The STAR pivotal trial is expected to commence in 2015 and will evaluate Cytori Cell Therapy™ as a potential treatment for impaired hand function in scleroderma, a rare autoimmune disease affecting approximately 50,000 people in the United States.
The January 14th informational session will provide an opportunity to understand the epidemiology of scleroderma and the planned trial design, to review previous trial data and other scientific support, and to learn about the scleroderma market opportunity.
About Dr. Dinesh Khanna
Dinesh Khanna, MD, MS, the Frederick G.L. Huetwell Professor of Rheumatology and an Associate Professor of Internal Medicine, is the director of the University of Michigan
Dr. Khanna is the author of over 160 peer-reviewed publications and book chapters. He has won numerous awards, including the 2007 Spirit of Leadership Award and the 2011 “Best Doctor of the Year” award from the Scleroderma Foundation. He is board certified in rheumatology. Dr. Khanna is currently funded by the National Institutes of Health and is particularly interested in the design of clinical trials and assessing patient reported outcomes in patients with scleroderma and leading novel international clinical trials in scleroderma.
Dr. Khanna is a fellow of the American College of Rheumatology. He was elected by his peers to the 2011-2012 Best Doctors in America, which recognizes the area’s top clinicians.


Dr. Khanna´s CV is pretty impressive too.... :whistle: :yep:

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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:
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