As a number of (slightly cocky and goading) readers pointed out today, my prior post on Starpharma’s utterly stupid pre-clinical announcement had a major flaw. In the interest of being comprehensive, I would like to make an additional follow-up comment, while simultaneously acknowledging my own incompetence and stupidity.
I was too busy telling you about the gaps in Starpharma’s underwhelming mouse study. I was so busy reacting with ridicule that in climbing over itself to make a completely sensationalist but irrelevant ASX announcement, presumably ahead of the AGM later this week, that Starpharma didn’t actually bother finishing the animal studies (still ongoing, apparently). I was so busy trying to calibrate you on the lack of controls and the basic lack of meaningful scientific information, that I forgot something super important.
What is that you may ask?
Well, the super-important information that I didn’t see – but that several other people did – was the lack of basic efficacy of the Herceptin (naked antibody) and Kadcyla (ADC) comparative treatment arms. Duh. Below is a figure from a nice paper in Clinical Cancer Research from 2011 that shows the type of response we expect to see in a SKOV-3 model with Herceptin. I should note that the Herceptin (trastuzumab) tumour response in this model is very typical.
It’s not even that the growth curves look just plain wrong (assuming a therapeutic dose was given) it’s that Starpharma’s presentation of the treatment response of the tumours in a Herceptin-sensitive model look basically the same as the control (saline).
Go back and look for yourself.
So yes, the message you should take home is this : not only was Starphama’s basic scientific integrity poor, and not only was the data incomplete, but the actual data itself is probably crap. I should also add that not only is it surprising that the company shows basically nil treatment effect in a Her2+ xenograft model that is known to respond well to Herceptin (and also Kadycla), but also limited administrated dose information is disclosed (route of administration, rationale given that it is an unusual dosing profile) for the comparative treatment arms. If I am being a stickler, there was also no data on animal weight loss (to contextualise tumour volume changes), which would be de rigeur …
Sloppy, sloppy, sloppy, and I am not just talking about myself here.
The bottom line is this. Biotech companies that have integrity don’t do very preliminary, very unvalidated experiments (i.e. that have not been repeated) and then issue a press release. They especially don’t issue a press release with the kind of headlines and ancillary commercial language such that some regulatory jockey at the ASX goes “ooh, this looks big” and marks it price sensitive.
This stunt is nothing more than share price manipulation in advance of an AGM, and it’s shameful.