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TOPIC: 13.4 million for BARDA trial awarded

13.4 million for BARDA trial awarded 31 May 2017 08:19 #9387

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Sorry, having problem posting release.
Not a site/lodge issue Fas

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13.4 million for BARDA trial awarded 31 May 2017 08:24 #9388

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SAN DIEGO, May 31, 2017 (GLOBE NEWSWIRE) -- Cytori Therapeutics, Inc. (CYTX) (“Cytori” or the “Company”) today announced that the Company and the Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response (ASPR), have executed a contract option valued at approximately $13.4 million.
The executed option will fund the Company’s RELIEF trial, a U.S. pilot clinical trial of Cytori Cell Therapy™ (DCCT-10) in thermal burn injury as the next step in development of Cytori technology as a medical countermeasure for thermal burn injury. The present option increases the overall BARDA commitment to Cytori technology to approximately $34.6 million thus far.
Patients with large burns frequently require treatment with an autologous skin graft. Unpublished preclinical data generated by Cytori under its BARDA-funded development program indicate that intravenous delivery of Cytori Cell Therapy was associated with increased formation of new skin (epithelialization) and earlier restoration of the barrier function of the newly-formed skin1. The RELIEF trial will apply the same approach in the clinic.
“Cytori continues to develop Cytori Cell Therapy technology as a multiuse platform for use in both the routine clinical setting and in the event of a mass casualty emergency,” said Dr. Marc Hedrick, President and Chief Executive Officer of Cytori. “There are several published reports indicating clinical benefit of Cytori Cell Therapy in chronic wound healing. This trial provides Cytori the opportunity to extend these reports by assessing utility of intravenous administration in an acute traumatic situation.” 2
The RELIEF trial will assess safety and feasibility of intravenous delivery of Cytori Cell Therapy™ as an adjunct to usual care in patients with thermal burn injuries covering between 20% and 50% of their body surface area. Subjects will have at least one deep partial or full thickness burn wound that is to be treated with a meshed autologous split thickness skin graft (STSG). Subjects will be randomized (1:2) to receive either usual care alone or usual care supplemented with Cytori Cell Therapy. While primarily focusing on safety and feasibility, the RELIEF trial will also assess a series of parameters related to skin graft healing. The trial is approved to enroll up to 30 patients in up to 10 U.S. sites with study initiation expected to occur in Q4 2017.
This project with BARDA was initiated to evaluate Cytori Cell Therapy as a potential medical countermeasure that could be used to treat thousands of patients with a combination of burn and radiation injury following detonation of an improvised nuclear device in a major USA metropolitan area. The first step towards achievement of this goal was completed in pre-clinical studies which reported that intravenous delivery of Cytori Cell Therapy improved healing of full thickness burn wounds complicated by radiation injury (linked here).
The RELIEF clinical trial represents the next step in this path. The original contract with BARDA retains two as-yet unfunded options valued at up to $68 million. The first of these options is written to support a pivotal clinical trial that could potentially follow RELIEF and lead to FDA approval of Cytori Cell Therapy as a treatment for thermal burn injury. The second option addresses additional preclinical work targeting application in thermal burn and radiation injury.
BARDA is developing medical countermeasures for use following a mass casualty disaster involving burns to address the ill-preparedness of the current healthcare system to deal with very large numbers of patients requiring treatment for thermal burns, particularly those complicated by concomitant radiation exposure. According to the American Burn Association, there were approximately 450,000 burn injuries in 2013 that required medical treatment in the United States, with approximately 40,000 requiring hospitalization. In a mass casualty event, the Government Accountability Office estimates that as many as 10,000 patients could require thermal burn care. The limited number of specialist surgeons and burn centers in the U.S. creates a public health need for a burn wound therapy that can be quickly and broadly applied by non-specialist medical personnel following such an event.  Current standard of care for large burns consists of dressings, skin grafts and skin substitutes. Despite these treatments, patients with severe burns commonly suffer from prolonged pain, aggressive scarring, skin contracture and reduced range of motion. Cellular therapeutics such as those offered by Cytori may have the potential to improve the quality and rate of wound healing and reduce scarring and also can be deployed in a cost effective manner, even in mass casualty situations.

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13.4 million for BARDA trial awarded 31 May 2017 08:30 #9389

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Fas,

Do the links disclose trial data previously unknown to stockholders?

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13.4 million for BARDA trial awarded 31 May 2017 08:38 #9390

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www.tandfonline.com/doi/abs/10.1080/09553002.2017.1242814?journalCode=irab20

Here you go DOV...this is what the link sends you to.

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13.4 million for BARDA trial awarded 31 May 2017 08:41 #9391

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At nearly $447K per patient I assume this award includes CTX2 work as well. Or buying of said machines.

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13.4 million for BARDA trial awarded 31 May 2017 08:45 #9392

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DOV wrote: Fas,

Do the links disclose trial data previously unknown to stockholders?


No- not that I know of. The link Hedge posted was one of two studies presented by Philipe Foubert at a burn conference I believe. If I recall right that one was in Chicago.

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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:

13.4 million for BARDA trial awarded 31 May 2017 19:24 #9393

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$447K per patient is very good. Of course some of this will go towards other related expenses including general administrative ones so this is a sorely needed cash infusion. Most important however is the validation of the treatment protocol and methodology.

Unfortunately the broader market does not appear to recognise the potential (yet), but it will be forced to do so when the positive scleroderma data is released. At that time they will be forced to acknowledge that here is a treatment paradigm that can treat a VERY wide range of conditions. The BARDA trials have been a long and drawn out process ......... the outcome from these trials however could be VERY profound as it would open up ADRC treatment to a VERY LARGE & DIVERSE patient base........ much, much larger than scleroderma (eg. wound healing irregardless of location).

The two key quotes below from the press release sum up the potential of CYTX ''

''The limited number of specialist surgeons and burn centers in the U.S. creates a public health need for a burn wound therapy that can be quickly and broadly applied by non-specialist medical personnel following such an event.''

'' Cellular therapeutics such as those offered by Cytori may have the potential to improve the quality and rate of wound healing and reduce scarring and also can be deployed in a cost effective manner, even in mass casualty situations.''

ie: don't need specialists to treat patients.
cost effective
can be made broadly available
treats wounds and reduces scarring (amongst other maladies)

CYTX has a tiger by the tail, and we shareholders are riding on its back.
The questions with regard execution of delivery of this paradigm changing treament will soon be the key area of angst. Lets hope that the disclaimer "Past performance is not indicative of future results" holds true in a positive way.

rongside (who is tired of his moniker & looking for a reason to change it)

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13.4 million for BARDA trial awarded 31 May 2017 19:59 #9394

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***ie: don't need specialists to treat patients.***

Of course you don't need a specialist....that's just a stupid FDA rule to (imho) protect their long drug regime that pays for their bloated agency.
#####
OK, some suggestions, just for fun.
Rightside...too obvious
Brightside
Liposide
Longside (the stock of course)
cytxcantkeepmedownside
:write: :grin:

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13.4 million for BARDA trial awarded 03 Jun 2017 09:21 #9418

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After a few years of not mentioning the CTX2 next generation, finally the device is getting the money needed to move from prototype to full production. Years ago, the CTX2 device was to be priced at $15,000 to $25,000 versus the Celution 800 pricing of $100,000. I wonder what today's thinking is around pricing?

Cytori has actually been very good at conducting clinical trials. Both ACT-OA and STAR came in ahead of schedule. But, Cytori has never been good at selling the Celution system or the consumables to the self pay market or even the charitable funded market (MAP).

Cytori's largest customer, Toyko Arthritis Clinic, has installed nine Celution 800 systems out of fifty locations. If the CTX2 device is priced correctly, I would expect much faster deployments in the future. It is good to see Cytori moving closer to commercialization. Their last two BOD appointments bring that skill to a heretofore empty table.

On a related note to the Avita Medical post, I heard this past week that the training required to treat patients for scleroderma of the hand takes all of 3 hours. Twenty sites have already been trained, but could use a refresher course. Getting to 40 won't be a big hurdle.

My personal prediction for the STAR results press release is Thursday, July 20th. (47 days to this binary event).
The following user(s) said Thank You: Joncon63, b767cpt

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13.4 million for BARDA trial awarded 06 Jun 2017 08:30 #9429

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Tiago Girao mentions in an email last week that D'Silva considers the BARDA award removal of an overhang. This Barda award has been negotiated over a few months and amount of the reward is almost $ 5 million more than the original $ 8 million.

This BARDA award is very important and this is why they hire Marino (a West Point graduate and a clinical pharmacologist) for the job.

Many important CYTX ongoing and pending projects are all pinched to this award: the CTX2 launch, the secondary Raynaud's , various plastic surgical applications, and maybe the nano regenerative medicine.

This BARDA project benefits the company more than BARDA. CYTX does not necessarily need a phase 3 to reap major corporate benefits in several areas. In the case of secondary Raynaud's, a phase 3 can be launched as long as the BARDA phase 1 data is indicative of patient safety and as long as the scleroderma early clinical data is indicative of some effectiveness in early signs of scleroderma - Raynaud's.

Indeed, what is ongoing at CYTX is great!

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13.4 million for BARDA trial awarded 06 Jun 2017 13:08 #9430

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rongside wrote:
Unfortunately the broader market does not appear to recognise the potential (yet), but it will be forced to do so when the positive scleroderma data is released. At that time they will be forced to acknowledge that here is a treatment paradigm that can treat a VERY wide range of conditions. The BARDA trials have been a long and drawn out process ......... the outcome from these trials however could be VERY profound as it would open up ADRC treatment to a VERY LARGE & DIVERSE patient base........ much, much larger than scleroderma (eg. wound healing irregardless of location).

franshei wrote: This BARDA project benefits the company more than BARDA. CYTX does not necessarily need a phase 3 to reap major corporate benefits in several areas. In the case of secondary Raynaud's, a phase 3 can be launched as long as the BARDA phase 1 data is indicative of patient safety and as long as the scleroderma early clinical data is indicative of some effectiveness in early signs of scleroderma - Raynaud's.

Indeed, what is ongoing at CYTX is great!


Surely the oldtimers remember the absolute magical healing written down in the peer reviewed Akita and Naples papers and recall the images of healed wounds from those scientific reviews.
I also strongly believe what that will translate to, regardless of the present whims of the market and its short contingent.

Our sunny days will come.

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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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