InVivo Therapeutics Hldgs Corp (fka NVIVQ)

[rru2s]

Quote from the individual poster I mentioned (from this message board a couple years ago):

Regarding InVivo’s preclinical work, on one hand, the CEO is always going around making bold statements claiming that their research findings so far have been uniformly positive (i.e., like you stated "they have not had mixed results"). On the other hand, what the CEO is not telling investors is that InVivo run into major problems in 2009 with the Oregon Health & Science University (OHSU) National Primate Center which they had contracted to conduct their preclinical SCI work in monkeys. This prestigious research center is one of eight National Primate Research Centers in the United States

http://www.bizjournals.com/portland/stories/2009/12/28/story6.html

http://www.peta.org/b/thepetafiles/archive/2009/09/22/onprc-kills-more-monkeys.aspx

Specifically, InVivo’s pre-clinical study was stopped after the first seven monkeys that had underwent spinal-severing surgery developed life threatening complications as a result and four of them had to be euthanized within days.

InVivo subsequently sued OHSU for not providing the monkeys with proper post-surgical care, which they say caused the routine bladder problems to become more serious issues and charged OHSU with halting the experiment and euthanizing the animals against the company's wishes.

OHSU countered that all monkeys received appropriate around-the-clock care after surgery and that it was InVivo who called a halt to the surgeries. Here is a quote from Jim Newman, the OHSU spokesperson at the time: "The day after surgeries began, we noticed that the surgery results were more severe than the company had predicted. We informed InVivo of these problems, and they voluntarily stopped the research."

As is often the case in unfortunate situations like this, the specific details of what exactly did go wrong remain a matter of dispute between the research institution and the company and both parties eventually reached an out-of-court settlement.

However, in light of this, it should make every investor wonder how the CEO rightfully can continue to say things like “We have treated over 40 monkeys and all of them – each one – is up and running in about 3 weeks” (this quote is from one of his recent TV road show appearances).

Plaintiff: InVivo Therapeutics Corp.
Defendant: Oregon Health & Science University
Case Number: 1:2009cv11458 Filed: September 1, 2009
Court: Massachusetts District Court Office: Boston Office County: Middlesex
http://dockets.justia.com/docket/massachusetts/madce/1:2009cv11458/124146/

The suggestion that the researchers at OHSU were simply incapable to properly carry out the animal experiments that they had been contracted to conduct is highly doubtful IMO. Most people would find it difficult to accept that a research institution of OHSU’s caliber would consent to run pre-clinical trials for a company that is trying to get FDA approval, if they did not think they had the proper infrastructure in place (i.e., proper housing and personnel for the care of animals, etc.) or their scientific research experts were not able to adequately carry out the required surgical procedures including the proper aftercare. These important issues are all addressed in the routine vetting procedures prior to signing a research contract - you do not find out about these kinds of problems while you are trying to run the actual experiments.

I have reviewed all of the US Department of Agriculture Animal and Plant Health Inspection Service (http://www.aphis.usda.gov/) Inspection Report data pertaining to OHSU over the time period that the InVivo monkey trial was run there. These reports clearly demonstrate that the Oregon National Primate Research Center received a clean bill of health and the responsible USDA investigators did not find any of the kinds of issues that InVivo alleged may have contributed to the unfortunate study outcomes.

In the end, I believe that these government reports are accurate. It looks like we disagree on what may have happened at OHSU.

FWIW, I have also done the same type of search (http://www.aphis.usda.gov/) for the year 2008 (i.e., to check more in-depth into the issues surrounding the PETA complaint). The Inspector Reports over that time period support what you cited from your first link and that OHSU was given a warning letter by the agency. However, the article written by Jeff Akst in its original version (available here: http://classic.the-scientist.com/blog/display/55985/) also continues to say:

“That government warning "was a very rare occurrence" at the school, Newman told The Boston Globe. "When we received it, we went through our records, which go back a decade, and we could not find another instance of receiving a warning."

Thus, the 2008 problem at the OHSU animal research center that you highlight in your reply was clearly an exception. I would think that after receiving a government warning letter, the key decision makers at the university at that time were especially motivated to do everything to make sure that those things were not going to happen again. A review of the official USDA Inspector Reports supports my assertion.

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Another post about the lack of ability to find the published results of the second and third studies (full scientific papers):

Other than information about InVivo's first monkey trial, where can I find the data (i.e., scientific publications) from the 2nd or 3rd monkey studies that would support the company's (and your) assertion that the success in primates has been replicated?

InVivo’s first monkey trial (i.e., the study that won the prestigious APPLE award from the American Spinal Cord Association in 2011) involved a total of 4 African green monkeys with one serving as experimental control, another one receiving a scaffold-only implant, and the remaining two animals receiving the scaffold with stem cells. It’s a great science project but obviously very limited in its scope.

As an investor in this company, I want to be able to independently substantiate the repeated comments made by the CEO Mr. Reynolds suggesting that all of their monkeys “where up and running in about 3 weeks.” As such, I have been waiting for a long time to see what InVivo’s follow-up monkey studies with larger sample sizes actually would be able to demonstrate. Last November at the Piper Jaffray’s Healthcare Conference Mr. Reynolds stated that these studies employed improved assessment methods (including wireless EMG systems) and that the results were “fantastic.” He also stated during the call that “We are just about to publish that second study.” Well, unfortunately, that was over 6 months ago and he has been selling stock in the order of 1.9 million dollars since that time.

FYI, for some time now, I have closely followed the published work coming out of V. Reggie Edgerton’s lab at UCLA since Mr Reynolds often alludes to him and Dr. Edgerton serves on InVivo’s scientific advisory board. According to a quick glance at Pubmed just now (http://www.ncbi.nlm.nih.gov/pubmed?term=%22Edgerton%20VR%22[Author]), since November 2011 Dr. Edgerton’s lab has published 12 refereed papers. Of these, two publications address a nonhuman primate model of SCI with one of them being a review article and the other an original study that involved 24 rhesus macaques that underwent C7 spinal cord at the California National Primate Research Center at UC Davis. Here are the citations:

Nout YS, Rosenzweig ES, Brock JH, Strand SC, Moseanko R, Hawbecker S, Zdunowski S, Nielson JL, Roy RR, Courtine G, Ferguson AR, Edgerton VR, Beattie MS, Bresnahan JC, Tuszynski MH. Animal models of neurologic disorders: a nonhuman primate model of spinal cord injury. Neurotherapeutics. 2012 Apr;9(2):380-92.
Nout YS, Ferguson AR, Strand SC, Moseanko R, Hawbecker S, Zdunowski S, Nielson JL, Roy RR, Zhong H, Rosenzweig ES, Brock JH, Courtine G, Edgerton VR, Tuszynski MH, Beattie MS, Bresnahan JC. Methods for Functional Assessment After C7 Spinal Cord Hemisection in the Rhesus Monkey. Neurorehabil Neural Repair. 2012 Feb 13. [Epub ahead of print]

I have been unable to connect any of this research work out of Edgerton’s lab to InVivo. Interestingly, though, the authors of the recent Neurorehabil Neural Repair paper state that their study design included an examination of the efficacy of non-specified “experimental therapeutics.” However, they do not report any results in their current publication but simply state that this aspect of their work is still the subject of a continuing study.

If you can direct me to a source that allows me to independently review the definite results of InVivo's more recent monkey studies, I would appreciate it. Crede sed proba is not a bad piece of investment advice, especially for penny stocks.