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TOPIC: Investor´s Note on Translational Work

Investor´s Note on Translational Work 25 Jul 2016 06:19 #7458

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The number of publications coming out recently and which I put on this board without "hearing" from Cytori apparently persuaded Hedrick to make a general statement of the "benefit" of Investigator sponsored trials... :whistle:

Jul 25, 2016
Dear Stockholders -
In recent months there has been a number of publications detailing the expanding research use of Cytori® Cell Therapy™ in disease states as varied as dental surgery, lymphedema, and erectile dysfunction. These publications are just the latest reports in the peer-reviewed literature in which clinical investigators around the world have applied Cytori technology in patients whose medical needs have not been adequately met by conventional therapy. Several of these studies have led to later stage clinical development including Phase 2 and Phase 3 trials of Cytori Cell Therapy. These include:
The positive SCLERADEC I investigator-initiated trial, data from which was included as part of the FDA submission resulting in the approval to conduct the STAR trial, a phase III pivotal trial in the USA. The STAR trial is evaluating Cytori Cell Therapy for patients with hand complications due to systemic scleroderma and is fully enrolled.
In Japan, positive data from an investigator-initiated pilot trial Cytori Cell Therapy for the treatment of stress urinary incontinence following radical prostatectomy led directly to both Japanese regulatory approval and government funding for the follow-on trial, ADRESU, a currently enrolling Phase 3 trial.
A series of publications from Japan and Europe reported use of Cytori Cell Therapy in the successful treatment of chronic non-healing ulcers including those from prior radiation therapy. This data was included in our original submission to BARDA as it provided evidence demonstrating feasibility in patients with radiation-related impairment of healing.
There are a number of other investigator-initiated studies (IIS) that are in earlier clinical development. For example, treatment of fistulas, which are abnormal connections or ‘leaks’ between two body cavities, has yielded a number of positive reports:
A team from the UK has published two case series reporting that Cytori Cell Therapy was used as part of a surgical procedure to close intestinal fistulas.
A team from Germany has published a case report of a difficult oral fistula that healed following treatment.
A Japanese team has published positive results from a trial of Cytori Cell Therapy in fistulas occurring after intestinal surgery.
A team in France is currently enrolling in a trial of Cytori Cell Therapy in patients with fistulas caused by Crohn’s Disease.
Erectile dysfunction is another area of IIS activity:
At Odense University Hospital in Denmark, the urology team recently published clinical trial results using Cytori Cell Therapy in erectile dysfunction.
Just recently, a new, but intriguing publication also from Odense University Hospital reported a patient with substantial resolution of lymphedema due to breast cancer surgery following a single treatment with Cytori Cell Therapy. Follow-up four months after treatment the patient had substantial reduction in her symptoms of arm heaviness and a 292mL reduction in arm swelling from edema. As a result of the encouraging outcome observed in this patient the Investigators have initiated a Phase 2 trial. The National Cancer Institute reports that 8% to 56% of women with breast cancer have lymphedema within 2 years of surgery for breast cancer.
So, to directly answer the question posed in the title, what does all this mean for Cytori investors?
First and foremost, this growing body of IIS data coupled with data from company-sponsored trials continue to show a strong safety profile, irrespective of the organ or disease targeted. This combination of safety and feasibility information facilitates discussions with regulatory authorities around the globe by providing additional data supporting a favorable benefit to risk profile of Cytori Cell Therapy.
Second, while in no way definitive, investigator-initiated studies continue to provide evidence of potential efficacy in a wide variety of indications demonstrating the value of the platform nature of Cytori’s technology. Doctors are continuing to adopt and adapt our technology for new diseases and clinical situations. This experience also helps Cytori in commercial planning for potential approvals in indications such as scleroderma of the hand and stress urinary incontinence while building relationships with international key opinion leading doctors.
Third, these trials function to assist in discussions with regulatory agencies. As was the case in our lead indication for scleroderma, these trials can then be incorporated as additional support for our formal clinical pipeline of company-sponsored trials.
In summary, investigator-initiated studies explore areas of clinical need in research settings. Such information assists in understanding in the potential role of Cytori Cell Therapy in improving lives of patients with poorly met medical needs. Independent Investigator Initiated Studies are being conducted in multiple regions around the world while we simultaneously continue our focus and corporate development resources on execution of rigorous late stage approval trials.
Thank you for your support of the company and confidence in our technology and team.


The publication on the site is very confusing with underlinings of certain words below which one would expect a link. They are nowhere there though- so as usual - very general and not really informative. :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:

Investor´s Note on Translational Work 25 Jul 2016 07:08 #7459

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Fas,

Hedrick must have read Rothco's comments about the clinical trials being meaningless.

On a more serious note, I wonder what inspired Hedrick to write this piece. It offered nothing new in terms of trial information. What he may have been trying to say is that the evidence is mounting that the Cytori Cell Therapy is safe and efficacious in many applications. More importantly, this is being noticed by regulators who are desperate to approve a cell therapy to set a quality standard. All of us can only hope this will lead to rapid approvals from all regulatory agencies and especially the FDA.

The September FDA hearing is approaching. Safety is the number one goal and standards need to be set.

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Investor´s Note on Translational Work 25 Jul 2016 08:16 #7462

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Three topics have not been mentioned intentionally, in my opinion:

1. Universal and local clinical data helps the 510 K sales and marketing in the Far East, particularly in Japan.

2. OA and recent OA limited approval in Japan are not mentioned. OA PR is pending.

3. IIS is safety first and efficacy is bonus - the bonus is not mentioned at this stage to avoid illegal promotion as many others, till the data becomes statistically meaningful or determined to be effective in the opinion of the attending physicians.

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Investor´s Note on Translational Work 25 Jul 2016 08:19 #7464

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DOV wrote: Fas,

On a more serious note, I wonder what inspired Hedrick to write this piece. It offered nothing new in terms of trial information. What he may have been trying to say is that the evidence is mounting that the Cytori Cell Therapy is safe and efficacious in many applications. More importantly, this is being noticed by regulators who are desperate to approve a cell therapy to set a quality standard. All of us can only hope this will lead to rapid approvals from all regulatory agencies and especially the FDA.

The September FDA hearing is approaching. Safety is the number one goal and standards need to be set.


DOV-
I personally do not expect anything from the FDA in the near term- reason: they are unlikely to change the core IND / IDE system, which also is the core of the cells & tissue regulation. I would simply be happy if they provide clarity and make short work of all the Cell Surgical Networks etc. The potential of all combined clinical effort for Europe as ATMP therapies or in Japan for both device and drug regulatory pathways, I believe are becoming very substantial though. :whistle:

From Hedrick´s write-up, the only thing I was not familiar with was the German oral fistula case- but turned out to be easily "googeble" - actually I remember now, that I have seen this already...see file

File Attachment:

File Name: 2013-OralFistulaADRCs.pdf
File Size: 1,939 KB
Attachments:

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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:

Investor´s Note on Translational Work 25 Jul 2016 08:24 #7465

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Just to play devils advocate, maybe this was released to say there is promise in the future but also as a buffer to what earnings may show next week. :evil:

Who really knows.

These PR's never really help much in terms of PPS firmness. :bash:

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Investor´s Note on Translational Work 25 Jul 2016 08:33 #7466

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DOV wrote: Fas,

Hedrick must have read Rothco's comments about the clinical trials being meaningless.


Or he might've read your comments over the weekend and thought maybe he should put together something over the weekend?

You should help him write stuff like this, or the least you can do is to stop writing with your left hand when writing for him? :joy:

More disappointments more dilution more of the same. Nobody wants this fraud of a company... no savior coming, keep on keeping on...
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Investor´s Note on Translational Work 25 Jul 2016 10:35 #7469

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Yes, very effective, at the time of this post we have traded 49,000 shares at $2.00 . To me that say's when you put lipstick on a pig it's still a pig. See Hilary Clinton :puke: Maybe numbers look better 735,000 at .13, think we are at an all time low.

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