Welcome, Guest
Username: Password: Remember me
The Company
  • Page:
  • 1

TOPIC: BARDA increases Contract Option

BARDA increases Contract Option 19 Sep 2016 06:57 #7686

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3337
  • Thank you received: 1115

SAN DIEGO--(BUSINESS WIRE)-- Cytori Therapeutics (NASDAQ: CYTX) (the “Company”) today announced that the Company and Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services, increased the contract option originally signed in August 2014 to fund continued investigation and development of Cytori Cell Therapy™ for use in thermal burn injuries.
The amended option is valued at $16.6 million, an increase of approximately $2.5 million from its previous value of $14.1 million. Upon Investigational Device Exemption (IDE) approval by the FDA, if received, Cytori will request that BARDA provide additional funding to cover costs associated with the completion of a pilot clinical trial. This trial will employ IV administration of Cytori Cell Therapy.
The supplemental funds from this amended contract will be used to support the remaining activities necessary to seek approval of the IDE and support clinical readiness. The original contract includes additional options, exercisable at BARDA’s discretion, valued at up to $68 million to fund both pilot and pivotal clinical trials and additional work in thermal burn complicated by radiation exposure.
“BARDA and Cytori continue to work closely to develop this technology in the interests of the nation,” said Dr. Marc Hedrick, President and Chief Executive Officer of Cytori. “Additional funding allows Cytori to complete activities necessary for conduct of a pilot trial with the objective of getting Cytori Cell Therapy into the clinic for thermal burn in 2017.”
The current healthcare system is ill-prepared for large numbers of patients requiring simultaneous treatment for thermal burns associated with radiation exposure. Current standard of care 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.
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.

Please Log in or Create an account to join the conversation.

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:

BARDA increases Contract Option 19 Sep 2016 07:12 #7687

  • DOV
  • DOV's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 347
  • Thank you received: 194
Not sure everyone knew this, but the previous Barda funding was authorized through September 2016. These funds fill the gap in government contract official "periods." The next contract period begins upon the IDE grant by the FDA.

As I remember it, this pilot trial will involve only about three burn centers and perhaps 5 patients per center. Once safety with efficacy is observed, there will be a much larger trial that won't end until perhaps 2019. Barda can (and Hedrick speculated WILL) pre-deploy CTX2 devices around the country prior to the end of the large trial. The underlying significance here is the IDE calls for IV administration of the cell therapy (already approved years ago in the EU).

This IV administration theme has some legs and I believe the company will conduct a scleroderma trial using IV to treat the lungs of patients. Of course, the money to do this must be raised in advance of any such trial (which leads to even more speculation).
The following user(s) said Thank You: Joncon63

Please Log in or Create an account to join the conversation.

BARDA increases Contract Option 19 Sep 2016 07:32 #7688

  • franshei
  • franshei's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 790
  • Thank you received: 103
1. Marino's background and experiences are great for any success in this BARDA contract. Beyond this, he is great for clinical development in other indications, as well as the scleroderma NDA preparation.

2. The IV use of the celution end product has an enormous implication in many, many illnesses, using along or in combination with local treatment (belly bath and iv use of cisplatinum for ovarian cancer is one example; topical and iv use of mitomycin C in bladder cancer is another).

3. Without BARDA, CYTX would not have the money to develop the iv route of administration. This is a major step in the right direction.

Please Log in or Create an account to join the conversation.

BARDA increases Contract Option 19 Sep 2016 08:16 #7689

  • rodney.strongg
  • rodney.strongg's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 1333
  • Thank you received: 19
Franshei,

It would be great if "this major step in the right direction" would get some positive SP action!!

Please Log in or Create an account to join the conversation.

BARDA increases Contract Option 19 Sep 2016 13:51 #7690

  • franshei
  • franshei's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 790
  • Thank you received: 103
FAS, is there any data (clinical and preclinical) suggesting iv administration and local administration of cytori therapy could yield equivalent results in cardio ischemia?

I think iv administration would be effective in Crohn's illness, as well as in some niche medical conditions. If the iv use is effective in big disease/illness categories, such as cardio illnesses/stroke, etc., the implication is......... (big).

Please Log in or Create an account to join the conversation.

BARDA increases Contract Option 20 Sep 2016 04:38 #7691

  • fas
  • fas's Avatar Topic Author
  • Offline
  • Moderator
  • Moderator
  • May the fat be with you
  • Posts: 3337
  • Thank you received: 1115

franshei wrote: FAS, is there any data (clinical and preclinical) suggesting iv administration and local administration of cytori therapy could yield equivalent results in cardio ischemia?


Not that I know of. But surely somebody must have tried in Europe and of course we do not know about it, but Hedrick does. Surely most of us recall Cytori received 90% of what they "wanted" with the Intravase approval early 2013. We- investors- wanted the no option CHF approval but that was not given by the Competent Authority. :cry: After that- ADVANCE, ATHENA and dropping ATHENA were nicely put in the drawer without informing investors.

Both Osiris and Aastrom have done their clinics IV, but that probably had more to do with the large size of cultured cells and the risk of senescence.

I think all auto-immune related disorders should be treated IV, which includes Crohn´s - but as I have often written- the Anti-Aging shot IV, will be my dream come true.

Please Log in or Create an account to join the conversation.

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:

BARDA increases Contract Option 20 Sep 2016 08:11 #7693

  • franshei
  • franshei's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 790
  • Thank you received: 103
To deliver effective local or regional therapeutic benefits (such as for CHF, stroke, even Crohn's), I think regional parenteral dosing (with selective blood vessels and flood flow) is preferred over general iv dosing. In oncology, for liver tumors, cancer drugs have been administered this way. (Again, Marino is a clinical pharmacologist and he should know all these tricks well - they do this kind of things all the time at Walter Reed/NCI/George Town in DC).

Please Log in or Create an account to join the conversation.

BARDA increases Contract Option 20 Sep 2016 13:16 #7701

  • rothco619
  • rothco619's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 467
  • Thank you received: 67
Since Barda news broke, volume has decreased and stock price has dropped. :bash:

Please Log in or Create an account to join the conversation.

BARDA increases Contract Option 20 Sep 2016 13:42 #7702

  • rodney.strongg
  • rodney.strongg's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 1333
  • Thank you received: 19
Rothco, isn't that par for the course for CYTX? The reality is that only a significant cash partnership will change the SP dramatically. Fas thinks we may see more than one before year-end. Let's hope so.

Please Log in or Create an account to join the conversation.

BARDA increases Contract Option 20 Sep 2016 14:15 #7703

  • rothco619
  • rothco619's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 467
  • Thank you received: 67
Definition of Insanity is to do the same thing over and over again while expecting a different result. :bash:

Please Log in or Create an account to join the conversation.

BARDA increases Contract Option 29 Sep 2016 11:29 #7728

  • franshei
  • franshei's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 790
  • Thank you received: 103
I think this BARDA contract and all the related pending clinical works (thermal burn, wound healing, Crohn's, etc in which stem cells will be administered parenterally) will move to the center stage.

One factor to consider is the introduction of CX2, a much smaller celution system, which can be used in combat, as well as all the other future clinical applications for other indications. Introduction of this new machine has to be strategically at the right time, otherwise it would affect the current sales and marketing. Beside, CX2 is being developed, partly using BARDA money.

Please Log in or Create an account to join the conversation.

BARDA increases Contract Option 29 Sep 2016 14:26 #7729

  • rodney.strongg
  • rodney.strongg's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 1333
  • Thank you received: 19
Franshei, CX2 should have been completed a year ago. Let's hope it is complete and is being withheld for some good reason. :bash:

Please Log in or Create an account to join the conversation.

BARDA increases Contract Option 01 Oct 2016 08:44 #7730

  • franshei
  • franshei's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 790
  • Thank you received: 103
Hedrick and Tiago were in NYC earlier this year and they went to meet with Roth The meeting was strictly professional. Roth wrote on this message board highlights of the meeting.

CX2 development is complete. The cost partly comes from BARDA and the release will be strategic and timely as I said.

BARDA initiation was very much Hedrick's efforts (in my opinion), when Calhoun and Saad were let go. In think a lot of r/d has put into place over the past two years, while OA and scleroderma took the center stage. By now, most OA and (local) scleroderma clinicals are out of the way, BARDA will take the center stage with iv dosing, of which the safety data alone will lead into other phase 2-3 trials in a very short time. I think Marino is a perfect fit to bring the company into a new phase - at that time, multi company partnerships will come much easily. In the mean time, I think scleroderma is more likely to attract a partner than the OA indication.

Please Log in or Create an account to join the conversation.

BARDA increases Contract Option 01 Oct 2016 09:13 #7731

  • myownhedgefund
  • myownhedgefund's Avatar
  • Offline
  • Platinum Boarder
  • Platinum Boarder
  • Posts: 2824
  • Thank you received: 202
>>> I think scleroderma is more likely to attract a partner than the OA indication. <<<

I agree a EU scleroderma partner should be the easiest hurdle.
Question is when ?
EU reimbursement is still years away. Plenty of time in a potential partners eyes.

Please Log in or Create an account to join the conversation.

  • Page:
  • 1
Time to create page: 0.107 seconds

Copyright Information

Copyright Fas Kuiters © 2016 young-foxes.com. All Rights Reserved.
This page is made with Joomla CMS and its various templates designed by Fas Kuiters with the excellent Themler tool.

 

 

Shared Spreadsheet Links

DOV´s Revised Projections for the Periods 2017 until 2020

Shareble link : HERE

Fas Kuiters Websites