That’s right, folks. Regeneus has a product development strategy that is unlike any other company in the entire world of biotechnology. It has decided to develop its products from “Man to Mouse”.
You read correctly…
While most of the rest of the biotechnology industry at least attempts to take a slightly cautious approach toward developing and validating regenerative medicine technologies, Regeneus (ASX: RGS) started life by administering stem cell therapies of questionable value pretty much directly into patients and now seems to be working backward into pre-clinical development of MSC stem cell technology. The original patient studies were presumably conducted on the basis that there are TGA exemptions for certain classes of biologics administered under physician supervision, namely autologous (“from self”) cell transplants. The company not only backed a marginally justifiable clinical practice, it then went on to spruik its technology as somehow “endorsed” by the AFL and NRL. Notably, the company got fairly damning coverage on ABC’s 7:30 report that resulted in a follow-up set of assertions that the media commentary around RGS was inaccurate.
Frankly, I am skeptical about how far off base the ABC report was. Especially now that the AFL is apparently our new “approval” body for orthopedic stem cell therapy.
Today’s ASX announcement, in my opinion, is reflective of exactly the type of concerns articulated in recent media coverage of the company.
In a fascinating turn of events, RGS announced today that it has made good progress with its pre-clinical development of “Progenza”, the allogeneic (“allo”) version of its MSC stem cell therapy for osteoarthritis. It also notes that it has now manufactured this product under “GMP” conditions (hmmm… I wonder what it did before?). Apparently, making some material for a clinical trial is a newsworthy item. I can’t imagine why, but it apparently is. What is amazing about this, is that Progenza is as far as I can ascertain, essentially the same MSC technology that was given as “HiQCell” for orthopedic injuries. It is the same concept – an adipose-derived (that’s fat) stem cell therapy, injected into a location in the body in the hope that it will deliver a miracle repair job. Amazingly, after having already injected its treatment (autologously) into 100ds of patients without really any kind of noteworthy pre-clinical development or validation, RGS apparently now feels that formal clinical development process is warranted – perhaps because an “allo” story sells better? Or maybe because it can see the writing on the wall for increased TGA scrutiny of autologous therapies in the near-future?
Investors beware. This is a big change in strategy.
By the way, for all you suckers out there who threw your self-managed super funds at Cynata (please don’t get me started today), have a careful read of RGS’ ASX disclosure, particularly the key headline point of “Demonstrates capacity to manufacture millions of therapeutic doses from a single donor”. Any problems or concerns with expanding MSCs derived from adipose tissue? Apparently not, it would seem that RGS is doing just fine without Cynata’s “game changing” technology, thank you very much. I also note there are potentially significant intellectual property issues with RGS dabbling in the allogeneic ortho/osteo arena as it my perception that Mesoblast (+ ex-Osiris stem cell business) has a strong IP position in this space, especially the use of allogeneic MSCs for osteoarthritis).
Of course the inductive reasoning here is that either Regeneus or Cynta is pulling your leg. Which one, I wonder? It’s a tough call…
Oh, and my “favourite” part of the ASX release? The forward-looking statement that “Regeneus is on track to receive ethics approval and commence recruitment for the trial in the first-half of 2015.” Wow. Whoever their ethics committee is, you are surely on notice. You apparently have no independence because a company is willing to announce a priori that they expect to get a study approved for an allogeneic stem cell transplant. Very disturbing and a real step backward for the perception of the academic integrity of stem cell research in Australia, especially since an “allo” transplant is NOT within the scope of TGA product exemptions and is frankly a bit of a stretch for a TGA-notified study (in my view). Especially for a company that has commercial intentions for a product, rather than academic institution conducing a proof-of-concept.
It’s bad enough that we have individual practitioners like Dr. Ralph Bright (of Macquarie Stem Cells), who is on the record with the statement “just because we don’t know the science behind it doesn’t mean to say that it doesn’t work” (a cosmetic surgeon who apparently feels qualified to inject stem cells into patient’s brain / CNS for neurodegenerative conditions). But when public biotechnology companies take the attitude that clinical best practice and patient ethics are just a “check box”, we have a serious attitude problem in our industry.