InVivo - moving forward to clinicals

[MarcT]

I bought a goodly amount of stock in this company recently and came across this article this morning and thought Id share:

"6:00 AM ET 4/13/12 | BusinessWire
InVivo Therapeutics Holdings Corp. (OTC/BB: NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI), announced today that it held a meeting with the U.S. Food and Drug Administration (“FDA”) in which they discussed the Investigational Device Exemption (“IDE”) application previously filed by InVivo for its biopolymer scaffolding to treat acute spinal cord injuries.
........
This is a significant step for all patients waiting for first in-man data using biomaterials for spinal cord injuries,” said Frank Reynolds, InVivo’s Chief Executive Officer. “We are pleased that our core team of multidisciplinary scientists, led by my partner, Bob Langer, has had the opportunity to meet with the FDA to discuss our platform technology. We are encouraged by the communication we have had with the FDA to this point, and pending approval of the IDE, we expect the clinical trial for our treatment of acute spinal cord injuries to commence during thesecond half of 2012."

Heres the link from their site:
http://www.invivotherapeutics.com/20...cord-injuries/


The company definitely doesnt follow the "mainstream" focus on treatment/cures, such as stem cells etc, but theyve been having very good results and are making huge process with the FDA. Geron's Medical Leader, Dr. Edwards, relocated to InVivo shortly before Geron dropped their clinical for SCI and the ceo of the company, Frank Reynolds, is a SCI recoveree who spent several years on his back in bed before being fortunate enough to begin seeing significant recovery. These guys are focused on not only finding a fix, but finding it as soon as they safely can, which is very refreshing.

Im fairly sure they collaborate with the Miami Project as well, but Im a bit fuzzy atm. Anyways, Im stoked to see some serious headway made and clinical trials on human SCI patients to begin in America soon. They will be starting with acute and hoping to move to chronic eventually (as seems to be the standard, as these things go).

Anyways, hope some people find this helpful and Id love to hear Dr. Wise's opinions on this treatment.

[StemCells&AtomBombs]

And all the injuries that happen from the date of this article untill trials start (and the for a long time afterwards) will become chronic sci. In my opinion, it doesn't make any sense to do acute trials first, feels like they got it ass backwards.
The trials will also take a lot longer than trials with chronics as they don't have the population. Look at Geron; how long did it take them to do three or four. It will take forever and during that time acute becomes chronic.
Like I said, ass backwards.

[Christopher Paddon]

And if you do clinical trials on acutes and get positive results, how do you know they might not have recovered naturally?

At least with chronics the situation has stabilized with no further natural recovery likely.

[topperf]

Dennis and Christopher - The facts you state above are mindbogglingly obvious .. How do we get scientist to recognize these simple reasons to focus on chronics?

[nrf]

And if you do clinical trials on acutes and get positive results, how do you know they might not have recovered naturally?

At least with chronics the situation has stabilized with no further natural recovery likely.

I think companies hope that patients get some return, therapy induced or natural, either way they will take credit and wait for the truckloads of money.

[ineedmyelin]

And if you do clinical trials on acutes and get positive results, how do you know they might not have recovered naturally?

At least with chronics the situation has stabilized with no further natural recovery likely.

I suffered a c4-c5 injury in a car accident. i was completley paralyzed from the neck down. completley paralyzed! for three long months i had to lay there as the drs would prick me with pin all up and down my feet, legs, arms, chest. i always had the same answere, i cant feel a thing, i cant move anything.

after three months the drs told me that i should have shown some signs of some recovery around the 2 month period. i was told they could not do nothing else for me and that i would need assistance with EVERYTHING for the rest of my life. i was moved to a rehab hospital.

after three months at rehab i was walking in the parallel bars. 22 yrs later i walk with only a regular wooden cane. i still have issues with bladder, i ha ve about 1 minute to find a bathroom or i have an accident. i used to use suppositories for bowel but i got control of bowel about 7 yrs ago, now bowel is normal.

i tell my story as absolute proof that it would be better to do trials in chronics. how can they tell whether acutes will or will not recover on their on, i did.

[StemCells&AtomBombs]

I suffered a c4-c5 injury in a car accident. i was completley paralyzed from the neck down. completley paralyzed! for three long months i had to lay there as the drs would prick me with pin all up and down my feet, legs, arms, chest. i always had the same answere, i cant feel a thing, i cant move anything.

after three months the drs told me that i should have shown some signs of some recovery around the 2 month period. i was told they could not do nothing else for me and that i would need assistance with EVERYTHING for the rest of my life. i was moved to a rehab hospital.

after three months at rehab i was walking in the parallel bars. 22 yrs later i walk with only a regular wooden cane. i still have issues with bladder, i ha ve about 1 minute to find a bathroom or i have an accident. i used to use suppositories for bowel but i got control of bowel about 7 yrs ago, now bowel is normal.

i tell my story as absolute proof that it would be better to do trials in chronics. how can they tell whether acutes will or will not recover on their on, i did.

Wow! That's one hell of a story and the perfect example of why they got to do it on chronics to show efficacy.
Wow

[east dragon]

if every emergency patient get full recovery,we will know invivo is successful.

[NowhereMan]

And all the injuries that happen from the date of this article untill trials start (and the for a long time afterwards) will become chronic sci. In my opinion, it doesn't make any sense to do acute trials first, feels like they got it ass backwards.
The trials will also take a lot longer than trials with chronics as they don't have the population. Look at Geron; how long did it take them to do three or four. It will take forever and during that time acute becomes chronic.
Like I said, ass backwards.

It's not ass backwards because they don't have a product that will work on chronic SCI, it only has the potential to work on acute SCI. Their device is about neuro-protection, not neuro-regeneration.

[0xSquidy]

if every emergency patient get full recovery,we will know invivo is successful.

And what "we will know" if just some patients get recovery? You know that each injury is likely to be very different than the next one right?

[Barrington314mx]

I suffered a c4-c5 injury in a car accident. i was completley paralyzed from the neck down. completley paralyzed! for three long months i had to lay there as the drs would prick me with pin all up and down my feet, legs, arms, chest. i always had the same answere, i cant feel a thing, i cant move anything.

after three months the drs told me that i should have shown some signs of some recovery around the 2 month period. i was told they could not do nothing else for me and that i would need assistance with EVERYTHING for the rest of my life. i was moved to a rehab hospital.

after three months at rehab i was walking in the parallel bars. 22 yrs later i walk with only a regular wooden cane. i still have issues with bladder, i ha ve about 1 minute to find a bathroom or i have an accident. i used to use suppositories for bowel but i got control of bowel about 7 yrs ago, now bowel is normal.

i tell my story as absolute proof that it would be better to do trials in chronics. how can they tell whether acutes will or will not recover on their on, i did.

wow. thanks for sharing. very interesting how much later you gained bowel control.


well this trial is good news for people that dont even know it yet. thats a plus. lets just hope they dont forget about telling us chronics that they would be working on a cure for us as well.

have they tried this procedure on a chronic injured animal? or is that completely pointless? sorry for my stupidity on this subject.

[KIM]

And what "we will know" if just some patients get recovery? You know that each injury is likely to be very different than the next one right?

So then never will be a cure cause all sci are different

[StemCells&AtomBombs]

It's not ass backwards because they don't have a product that will work on chronic SCI, it only has the potential to work on acute SCI. Their device is about neuro-protection, not neuro-regeneration.

That's exactly part of the problem. is they went to work directly on acute injuries, unless I'm missing something and they discovered this accidentally and it was too good to pass up.

[0xSquidy]

So then never will be a cure cause all sci are different

False. Different kinds of injuries will need different kinds of treatments. There's no "one fits all".

http://en.wikipedia.org/wiki/False_dilemma

[Chaz19]

wow. thanks for sharing. very interesting how much later you gained bowel control.


well this trial is good news for people that dont even know it yet. thats a plus. lets just hope they dont forget about telling us chronics that they would be working on a cure for us as well.

have they tried this procedure on a chronic injured animal? or is that con this subject.

In my honest opinion, I don't think they're going to forget about us at all. Just a few weeks ago, they were the platinum sponsor the Massachusetts chapter of the spinal cord injury Association gala event. Frank Reynolds and Ed Wirth attended and could not be more supportive/friendly/willing to take questions from our chronic population. Like everything we need to stay cautiously optimistic.