Sirtex Medical Limited (ASX: SRX) announced this morning it had completed patient enrolment for a randomised, controlled clinical study directly comparing the company's SIR-Spheres against the existing 'standard-of-care' (best established medical practice) drug sorafenib, in patients with primary liver cancer.
Conducted solely in France, it has taken over 3 years to recruit the 400-some participants in the trial (named Sarah), and results are not expected until late 2016.
The clinical trials will examine safety and tolerability, as well as tumour response rates, quality of life scores and overall healthcare costs of the two different treatments.
It's a really big deal for Sirtex, as if SIR-Spheres are found to be significantly better than existing therapy sorafenib, it could pave the way for SIR-Spheres becoming the standard therapy for advanced liver cancer, thus leading to a massive boost in sales.
As an interesting point, you can tell the difference between a serious medical research company and a speculative biotech prospect by the amount of hype they put into their releases.
With a speculative medical/biotech company, announcements always focus on future profits and developments that could come, the classic 'gonna' syndrome.
Sirtex's announcement today doesn't include a single word about earnings, which is how you know they're the real deal. They're focussed on success, not share prices. They're also aware that there is no guarantee with clinical trials – SIR-Spheres may be no more effective than sorafenib for liver cancer.
(For more insight into medical/biotech company announcements, check out this article here)
As a second interesting point, readers should pay very close attention to how long it took Sirtex to rustle up this randomised controlled trial (the 'gold standard' of trials) – over three years to recruit the patients, and another 18 months to test them.
That makes some of the ASX's latest hot stocks – like Novogen Limited (ASX: NRT) or Cynata Therapeutics Ltd (ASX: CYP) – look unbearably risky, especially in context of their recent price rises.
Novogen and Cynata's therapies haven't even begun clinical tests yet (i.e., haven't been tested on humans), and when you look at the kind of time frames Sirtex is facing, both Novogen and Cynata could well be 5 to 10 years away from delivering a sellable product.
That's assuming both Cynata's and Novogen's therapies are viable, which is impossible to determine as they haven't yet been clinically tested!
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