Dear Dr. Kelly,
For a guy of your purported intelligence and charisma, and alleged grasp of oncology drug development, I am getting a bit tired of your company’s crappy press releases announcing that yet another mouse or two have been “successfully” treated with one of your drugs. Aside from the fact that most self-respecting pharmaceutical companies don’t actually brand a drug until it has shown significant efficacy in two-legged patients (because brand names loiter and create negative associations with the company’s name if they fail). Aside from the fact that every time I write a post and use the word “Anisina”, I wonder whether it shares a common etymology with the word asinine, which is the Anglicisation of asininus, a 15th century derivation of the Latin word asinus – or “anus” – clear evidence that one of the hacks in your science lab is doing your product branding. Aside from the fact that the content of your press releases provide no real insight into the progress of the company and are a fairly blatant abuse of ASX continuous disclosure rules. Aside from all these little irritating and inconsequential things, I have three significant reasons to suggest you stop this practice:
1) It is not the company’s prerogative to “fast track” clinical studies, it is that of the regulators. Although your press releases contain the customary forward-looking statement disclaimers, indicating (on a rolling basis) when your clinical trials will start on the merits of a scientifically incomplete pre-clinical data set, is inappropriate. Moreover a mouse study does not “clear the way” for a clinical trial. A robust CMC pack, reproducible batch manufacturing for your trials, a suitable toxicology study (more on this in a minute), an ethical clinical trial plan, and a notice of allowance from a regulator (i.e. the TGA or the FDA) “clears the way” for a clinical trial, and not before. In fact, when regulators read press releases like this, it actually pisses them off and makes them less inclined to be engaging when you do eventually get around to submitting an IND.
2) No “observable” toxicity in a pre-clinical model at a working therapeutic dose is not an indicator of safety. Toxicology is not “observed” – it is evaluated on the basis of detailed and sophisticated rodent histology that evaluates the organ-by-organ pathophysiology of an augmented dose. Your drugs are extremely toxic in their own right (let alone the cumulative toxicity of a combination product, as you have informed is the game-plan for the pediatric market) and until you have delivered an appropriate tox study, these statements are at best inappropriate and at worst, misleading. Incidentally, if you had got your act together and actually just run a toxicology study back in March, the last time you gave us a micky mouse update, you’d be done by now. It doesn’t cost much, there are plenty of labs that can do a basic 100x dose, 14 day acute NOAEL toxicology study with GLP materials. It’s not a slam-dunk as far as patient safety goes, but it would be a very nice start. If you need some help, send me an email : email@example.com and I can introduce you to some appropriate CROs.
3) Completing a mouse study is not a price-sensitive event. Treating (homogeneous) cancer cell lines in a tumor xenograft model is not a price-sensitive event. Announcing scientific “facts” without presenting peer-reviewed data in an appropriate forum is not a price-sensitive event. So why do you bore us with this information on a constant basis?
Dr. Kelly, every time your company files one of these ASX disclosures, I am going to ridicule you – just as I do PharmAust and others. It’s not special treatment. I’m not singling you out, I just have a strongly developed sense of toilet humour and a lot of visually compelling ideas that need realisation. It’s an itch, if you will. Novogen’s announcements will always warrant a special degree of satirical reflection because you do a far more extensive job of spouting crap than anyone else, though I must say I do enjoy your gushing soundbites from the development team. It’s a nice human touch. I’m a sucker like that.
We appreciate that you tested your drugs on yourself. That probably was worth a bit of media coverage – though it was a bit of a crass publicity stunt and perhaps best kept between you and the guy with the black hooded cloak and the iron sickle. Unfortunately giving us mouse-by-mouse coverage of your development program is not media-worthy, is intensely annoying, and merely serves to illustrate that your company isn’t worth taking seriously by investors, asset partners or patients.
Please don’t make me become a shareholder so that I can harass you about this at AGM meetings.
Chris Behrenbruch, Ph.D
The Long Tail