EyePoint Pharmaceuticals (vorher: PSIVIDA) startet durch !! (Seite 1159)

[Friedwart1]

Hallo Leute,

kann mir mal bitte jemand den Text übersetzen.

Warum steikt den der Kurs von psd?

[toothstone]

Schau einfach unter bigcharts ausd.
Oder asx.com, oder google dir eine au. stock quotes Seite.

[biotech_nett]

Hallo ,

macht sich das Warten endlich bezahlt??????

Wer kann mal bitte den Link zur Aussie-Börse reinwerfen???

Wo sind die ++++32%%%???

[riskfreak]

Na also!- geht doch!

[rattelu]

Geil,
gestern Siri heute Psivida!!!
Was kommt morgen?
Ich bitte um Vorschläge.

[toothstone]

Danke @ general, culturecom bin ich leider raus.

[dergeneral]

Guten Morgen

@toothstone nadu, auch noch dabei *freu*
bei Culturecom ging es in HK auch über 4% nach
oben!

Hier deine gewünschte Info!!

ASX/MEDIA RELEASE 7 October 2004
Positive Interim Results for BrachySilTM Trial
Phase IIA BioSiliconTM trial in Man shows Safety and Tumor Regression
Global nanotechnology company pSivida Limited (ASX: PSD) and Singapore General
Hospital (SGH) are pleased to announce Interim data analysis from pSivida’s phase IIA
trial at SGH has confirmed expectations that BrachySilTM (32-P BioSiliconTM) is safe and
effective at tumor regression.
The first 4 patients-all with inoperable liver cancer-have shown no product related
adverse side effects and up to 60% regression of tumours.
All 8 patients required for the approved trial have received BrachySilTM treatment at
SGH. This interim report announces the results in respect of the first 4 patients
reviewed 3 months after administration.
BrachySilTM is expected to be on the market worldwide during 2007 initially for liver
cancer and thereafter for the treatment of a wider variety of cancers involving solid
tumours following regulatory approvals.
Current brachytherapy style products being “in the body localized radioactive treatment
of tumours “are limited to liver and prostate tumours by virtue of their manner of
delivery.
The current brachytherapy market is growing and is estimated to be worth more than
US$ 1 Billion per year. BrachySilTM has the potential to significantly expand the current
market size through application to other cancers as a result of the successful fine
gauge direct needle delivery procedure. The procedure is undertaken without surgery
under local anaesthetic and patients were discharged the following day.
This study has established four key findings:
· SAFETY - No product related adverse events
Unlike other liver brachytherapy approaches that involve delivery via the hepatic artery and,
in cases, result in radioactivity becoming associated with healthy tissue, BrachySil™ is
administered directly into tumours restricting radioactivity to the tumour itself.
· EFFICACY - Treated tumours demonstrate significant tumour regression
Implantation of tumours with BrachySil™ has resulted in tumoricidal activity around the
implantation site. Although the primary objective of the study was to determine the safety
profile of BrachySil™, CT scan analysis of tumors at the time of treatment and 3 months
later demonstrates significant tumor regression in all targeted lesions with a maximum
regression of 60% from the dose used in the trial.
· SPECIFICITY- Retention of radioactivity in the tumour
A key finding is that the radioactive 32P-BioSiliconTM nanostructured microparticles remain
in the tumour with no or insignificant detectable radioactive leakage. This observation is a
very significant outcome for the trial.
· EASE OF APPLICATION - Practical and rapid treatment of tumours with ultrasound
and CT guidance
The procedure established by the Principal Investigator and his team at SGH has been
shown to be straightforward and accurate for the treatment of tumours. From a market
perspective this demonstration is in line with the company’s strategy to develop a simple
procedure for the interventional radiologist to selectively treat specific tumours. A multi
injector is in design phase to treat larger tumours with multiple implantations from a single
entry.
pSivida’s Managing Director, Mr. Gavin Rezos, said, “This ‘first in man’ evaluation of
BioSiliconTM has met our expectations on safety and of the needle injection procedure. The
ability of BrachySil™ to retain the radioactivity at the injection site is excellent news.”
He added, “Product launch for BrachySilTM is scheduled for 2007, following the Phase IIB trial
next year. The expectation that BrachySil™ will follow a ‘device-based’ regulatory route
means shorter development and registration timeframes. Second stage commercialisation will
target other major cancers to extend the range of potential applications of BrachySilTM.”
The Company also expects to achieve revenues from 2005 from licensing activities in other
areas of the BioSiliconTM technology platform.
NOTES ON THE PHASE IIA TRIAL
1. The primary objective of the trial was to assess the safety profile of BrachySilTM and delivery
by fine gauge needle directly into tumours, with a secondary objective of providing efficacy
data on tumour regression. The trial was conducted in patients with inoperable primary liver
cancer.
2. The trial will continue to conclusion to encompass 3 month & 6 month reviews of all patients
for product regulatory approval purpose, these interim results enable pSivida to prepare for
BrachySilTM dose optimization studies for increased tumour regression and multi centre
Phase IIB studies to commence in 2005.
NOTES ON BRACHYSIL AND COMPETITIVE ADVANTAGES IN
BRACHYTHERAPY
1. 32-P-BioSilicon™ is being manufactured to worldwide regulatory guidelines by supply chain
contract partners including Atomising Systems Limited (ASL) in the UK and Auriga Medical,
a division of AEA Technology QSA, Germany.(AEA). AEA is a leading global producer and
supplier of radioisotopes for healthcare.
2. Brachytherapy treatment utilising BioSilicon™ includes the following significant advantages:
· Versatile Device - application in both Brachytherapy and localized chemotherapy.
· P32 is a short range emitter compared to Ytrium and Iodine Isotopes (long range emitters)
used in existing brachytherapy products.
· P32 minimises damage to healthy tissue by its short range and allows direct
administration to the patient without the need for shielded rooms or robotic injectors
allowing treatment in hospitals without the need for investment by hospitals in those
facilities.
· BrachySilTM is delivered under local anaesthetic and patients can be discharged the next
day.
· 14 day half life provides for ease of logistics and treatment regimen compared to Ytrium
90 at 64 hours.
· Range of Tumours – fine gauge needle administration method allows application to solid
tumours in a range of cancers not just liver and prostate cancers being current
brachytherapy treatment areas. This has the potential to expand the brachytherapy
market size.
· Direct Delivery - minimizes side effects and maximize dose size.
· Inexpensive Device - low cost and abundant availability of silicon, with scale up proven.
· BioSilicon™ is radiation hard allowing ease of manufacture of BrachySilTM from
Phosphorous (P) doped silicon used in the electronics industry.
-ENDS

[toothstone]

Morgen,
super, und ich hab durchgehalten, hat jemand den Grund festgestellt?

[BarnyXXL]

#1267

DANKE !!!!

Bin jetzt hellwach !!!

[Schonaj]

ich glaubs ja nicht

so kann ein Tag anfangen!!!