> UK news is calling it a device.
The company has had indications that it will be registered as a device, at
least in Asia and Europe.
> Yet the 4th pdf is calling it a treatment.
I don't know if 'treatment' has a precise meaning in such a context. If so,
my guess is that it was used loosely in the announcement.
> In any event, way too premature to be announcing it here and especially
> alt.support.cancer.
Sorry. I wondered if it was appropriate, but there's quite a few
cross-postings to these groups, and I thought that some people might like to
know, so they can keep an eye on it.
> Your cohorts are too small, not enough details, and not enough time has passed.
I agree that more trials are needed. However, given the simplicity of the
treatment, the results so far look very promising. The effect of
radionuclides is well known. You just know that if you put a beta emitter
such as P32 close to human cells, it is going to kill them, so there can be
little doubt that this treatment is going to cause regression of tumours. A
greater concern is the possibility of leakage of the P32 to the healthy
liver tissue or the rest of the body. Apparently, leakage is the reason that
other forms of brachytherapy need to use inferior radionuclides such as
yttrium 90 and iodine 125. In the case of porous silicon, the phosphorus is
well-bound to the silicon, so leakage can only occur if entire particles of
the porous silicon can move elsewhere. I don't know how likely that is, but
it is certainly encouraging that it hasn't happened in any of these
patients.
There was a briefing on the 18th of March this year at which the company
said that all eight patients were still alive, but I don't know how likely
that was anyway if they hadn't received the treatment or had received a
different treatment.
> Where's the information as to the 12 Singapore patients from last June?
I don't know where you read that there were 12 patients. There was an
announcement on 15 June 2004 that the first two patients had received the
treatment, and I believe they were the first two of the eight for whom we
have the results.
David
David White - 12 Apr 2005 01:53 GMT
> > Where's the information as to the 12 Singapore patients from last June?
>
> I don't know where you read that there were 12 patients. There was an
> announcement on 15 June 2004 that the first two patients had received the
> treatment, and I believe they were the first two of the eight for whom we
> have the results.
I'll guess that you've come across the article at
http://news.bbc.co.uk/1/hi/sci/tech/3812987.stm, or something similar. I
don't remember if it was ever announced that there would be 12 patients, but
I'm sure that there weren't. The reporting of this treatment has been rather
poor. That article confuses two completely different kinds of treatment that
can be delivered by porous silicon - drugs and radionuclides - and claims
wrongly at the beginning that BrachySil is a drug treatment and that that's
what the Singapore patients received. Drug delivery by porous silicon is
actually the company's focus, but it's not as far advanced as the
radionuclide. The article at
http://www.abc.net.au/news/newsitems/200410/s1225290.htm is even worse. It
talks about silicon "chips", as though the silicon particles are some kind
of space age electronic devices, which is utter nonsense. The "chips"
description might not have originated there, but, wherever it started, it
soon appeared all over the place. It's all good publicity I guess, but I'd
rather they got it right.
David
Steph - 03 May 2005 15:08 GMT
>> UK news is calling it a device.
>
[quoted text clipped - 51 lines]
>
> David
Local treatments for metastatic cancers are just plain silly
David White - 05 May 2005 02:07 GMT
> Local treatments for metastatic cancers are just plain silly
I'm not sure what you are referring to. The disease treated in the BrachySil
trial was primary liver cancer, and I imagine that the trial coming up is
for primary pancreatic cancer. However, such a treatment would be worthwhile
for secondary tumours as well if those tumours are the most life-threatening
the patient has.
BTW, the current data from the BrachySil trial will be presented at the
European Society for Therapeutic and Radiation Oncology Conference in
Budapest on 5th May.
David
P.S. I have no medical training, so let me know if I say anything plain
silly.
David White - 06 May 2005 00:44 GMT
> BTW, the current data from the BrachySil trial will be presented at the
> European Society for Therapeutic and Radiation Oncology Conference in
> Budapest on 5th May.
This is the abstract from the conference:
Proof of concept of novel 32P Brachytherapy device in hepatocellular
carcinoma (HCC) in man
A.Goh(1), R. Lo(1), T.N. Lau(1), A.Y. Chung(1), D. Ng(1), W.K. Yu(1), S.
Loong(2), M. Chng(1), S. Somanesan(1), B.C. Lim(3), S. Connor(4),
P.K.Chow(1)
1 Singapore General Hospital
2 National Cancer Center Singapore
3 pSiOncology Pte Singapore
4 pSiMedica Ltd, Malvern UK
Hepatocellular carcinoma (HCC) is the 4th most important malignancy
worldwide. The vast majority of HCC are however unresectable and therapy in
this group remains poorly efficacious and the prognosis dismal. Interstitial
brachytherapy of solid hepatic tumours such as HCC is potentially
advantageous but the requisite for widespread clinical application is a
delivery vehicle with properties that can reliably confine the radiation
source to the implantation site. A novel implantable medical device
comprising 32P and proprietary porous silicon, BioSilicon(T) (BrachySil(T))
was investigated in eight patients with non-resectable HCC in an open label
single dose trial. Patients received single intratumoural implantations
introduced percutaneously under sonographic / imaging guidance into a
maximum of three tumours (4 MBq/ml tumour). The procedure was very well
tolerated by all patients. Follow-up assessment at close intervals up to 12
weeks demonstrated no significant product-related adverse clinical or
haematological effects. Examination of blood parameters suggested no
extrahepatic leakage of radioactivity from the device implanted. Although
the primary objective of the study was to determine safety and tolerability,
the anti-cancer activity of BrachySil(T) was confirmed with CT evaluations
showing significant tumour regression at all implantation sites. The study
establishes proof of principle for BrachySil(T) in the treatment HCC as a
tolerable and effective brachytherapy agent.
David