Replies to post #7601 on Generex Biotechnology Corp. (fka GNBTQ)

[WeeZuhl]

Info from the conference call in December which sounds like they have sufficient data to move forward with the product(s):

Excellagen is a highly purified, collagen-based gel, extracellular matrix, which has been shown to be substantially more effective than the standard of care using only one to two treatments.

The matrix study showed 68 percent more activity than the standard of care for wounds less than 3 square centimeters and 194 percent greater than standard of care for larger wounds. Equally as important is the speed at which Excellent reduces wound size. After only one application, Excellagen reduced the wound size by 362 percent over standard of care in the matrix study.

I don't need anyone to describe the data for me in a conference call when I can click the link and look at it for myself. I can say with no uncertainty that there is no published data to support what was described above in the conference call, and if it is unpublished then obviously it is not published in a peer-reviewed publication and should not be touted as such. Click the link and you can learn the data for yourself. First, the bovine collagen 2.6% product that is now called Excellagen ("FCG Group") was not even the study molecule for the MATRIX study. They included FCG Group as a **NEGATIVE CONTROL** but it performed as well as their study molecule, so they considered it a positive result for FCG. But the authors very clearly describe multiple problems in their methodology that resulted in a lack of significance of their findings. One thing they did that was NOT considered a problem was a two week lead-in period in which they excluded all wounds that were healing with standard care, so the study was designed to look at difficult wounds, which is perfectly fine, but they never mention this when they describe the results. They don't describe the product as designed to help difficult wounds, they say it is "substantially more effective than the standard of care," which is misleading at best and an outright lie at worst. Another very sketchy thing they did was to *RETROACTIVELY* exclude >30% of the completers. These are participants who FINISHED the study but then much later were excluded based on WEEK 1 data. They don't tell us the breakdown of the excluded patients, but the two test groups had n=72 and n=33, while the standard care group had n=19, so the most likely possibility is that most of the retroactively excluded patients came from the standard of care group. You can make your data look like whatever you want by retroactively excluding good performers from the standard care group. More than 30% of completers being retroactively excluded is enough all by itself to invalidate the entire study. The authors repeatedly say further studies are needed with alternative methodologies. This product may be helpful to speed up healing for certain types of wounds, but it is not better than standard care for most types of wounds. And this was published in 2011, so the standard of care for wounds has changed substantially in that time period, especially with prolific usage of wound vacs. The MATRIX study data is old, flawed, and proves nothing unequivocally. Anybody who describes this data as impressive or robust or as proof of anything is either not capable of interpreting scientific data or is intentionally misrepresenting the scientific data. Anybody can read it and see for themselves...



https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3443373/pdf/wrr0019-0302.pdf