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| ASX/MEDIA RELEASE |
19
September
2006
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Initiation
of Phase II clinical study of novel ophthalmic product
Boston,
MA. and Perth, Australia - Global bio-nanotech company pSivida Limited (ASX:PSD,
NASDAQ:PSDV, Xetra:PSI) is pleased to announce the initiation of a Phase II
clinical trial of Mifepristone (otherwise known as RU486) as an eye drop
treatment for steroid associated elevated intraocular pressure
(IOP).
The
investigator sponsored trial will involve up to 45 patients in the United
States. pSivida will be supplying clinical trial material for this study and
have filed a patent application on this product class.
Elevated
IOP may occur in patients receiving steroidal treatment for chronic eye
diseases. The trial will investigate the use of Mifepristone as a means to
prevent elevation of IOP from intraocular steroid exposure. Mifepristone is
a
steroid receptor antagonist (“steroid blocker”) already approved by the FDA.
This study represents a potential new use of an existing drug, made possible
by
a new delivery system.
“We
believe the trial of Mifepristone as
a
treatment for elevated IOP is an important study for the steroidal treatment
of
chronic eye disease,” said Dr Roger Brimblecombe, Executive Chairman and CEO of
pSivida Limited. “This program highlights pSivida’s focus on drug delivery
strategies to generate clinically significant advances and move products rapidly
through the regulatory pipeline. There are now two FDA approved products, one
in
Phase III clinical trials and two more in Phase II clinical trials all using
our
delivery technologies.”
RetisertTM
is the
only FDA approved sustained release back of the eye treatment for uveitis,
a
leading cause of blindness in the United States. Licensed to Bausch & Lomb,
RetisertTM
is
marketed in the United States and covered by Medicare and Medicaid.
A
next
generation product, MedidurTM
is in
Phase III clinical trials and is licensed to Alimera Sciences for the treatment
of diabetic macular edema, the leading cause of blindness for people under
the
age of 65 in the United States. MedidurTM
differs
from RetisertTM
in that
it is ‘injected’ into the eye through a standard gauge needle in an office
procedure rather than a surgical procedure.
-ENDS-
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pSivida
Limited
Brian
Leedman
Investor
Relations
pSivida
Limited
Tel:
+ 61 8 9226 5099
brianl@psivida.com
|
US
Public Relations
Beverly
Jedynak
President
Martin
E. Janis & Company, Inc
Tel:
+1 (312) 943 1100 ext. 12
bjedynak@janispr.com
|
European
Public Relations
Accent
Marketing Limited
Eva
Reuter
Tel:
+49 (254) 393 0740
e.reuter@e-reuter-ir.com
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NOTES
TO EDITORS:
pSivida
is a global bio-nanotech company committed to the biomedical sector and the
development of drug delivery products. Retisert™ is FDA approved for the
treatment of uveitis. Vitrasert® is FDA approved for the treatment of
AIDS-related CMV Retinitis. Bausch & Lomb own the trademarks Vitrasert® and
Retisert™. pSivida has licensed the technologies underlying both of these
products to Bausch & Lomb. The technology underlying Medidur™, a treatment
for diabetic macular edema, is licensed to Alimera Sciences and is in Phase
III
clinical trials.
pSivida
owns the rights to develop and commercialise a modified form of silicon
(porosified or nano-structured silicon) known as BioSilicon™, which has
applications in drug delivery, wound healing, orthopaedics, and tissue
engineering. pSivida’s subsidiary, AION Diagnostics Limited is developing
diagnostic products and the subsidiary pSiNutria is developing food technology
products both using BioSilicon™.
pSivida’s
intellectual property portfolio consists of 70 patent families, 74 granted
patents and over 290 patent applications.
pSivida
conducts its operations from offices and facilities near Boston in the United
States, Malvern in the United Kingdom, Perth in Australia and Singapore.
pSivida
is listed on NASDAQ (PSDV),
the
Australian Stock Exchange (PSD)
and on
the Frankfurt Stock Exchange on the XETRA system (German Symbol:
PSI. Securities Code (WKN) 358705).
pSivida is a founding member of the NASDAQ Health Care Index and the Merrill
Lynch Nanotechnology Index.
The
Company's largest shareholder and a strategic partner is QinetiQ, a leading
international defence, security and Technology Company, formed in 2001 from
the
UK Government's Defence Evaluation & Research Agency (DERA). QinetiQ (QQ.)
was instrumental in discovering BioSiliconTM
and
pSivida’s strong relationship with QinetiQ includes access to its cutting edge
research and development facilities.
This
document contains forward-looking statements that involve risks and
uncertainties. The statements reference potential products, applications and
regulatory approvals. Although we believe that the expectations reflected in
such forward-looking statements are reasonable at this time, we can give no
assurance that such expectations will prove to be correct. Given these
uncertainties, readers are cautioned not to place undue reliance on such
forward-looking statements. Actual results could differ materially from those
anticipated in these forward-looking statements due to many important factors
including: our inability to raise additional funds at favourable terms or any
terms; our inability to repay the amended notes; issues relating to share
registration in the U.S. that may delay our registration; our inability to
develop proposed products, including without limitation, in the drug delivery,
wound healing, orthopaedics, and tissue engineering, diagnostics and food
technology fields; failure of our evaluation agreements to result in license
agreements; failure to develop applications for BioSilicon™ due to regulatory,
scientific or other issues; failure to complete negotiations for new centers
for
the BrachySil™ phase IIb clinical trial for inoperable primary liver
cancer; failure of our discussions with the FDA for BrachySil™ to continue or to
lead to FDA approval; failure of the BrachySil™ phase IIb clinical trial
for inoperable primary liver cancer to determine the optimal dose, provide
key
safety data or support future pivotal efficacy trials or product registration
or
approval; failure of the BrachySil™ primary liver programme that is in
phase IIb clinical trials to provide a valuable platform for the
development and commercialisation of BrachySil™ for pancreatic cancer and other
indications; failure to commence phase IIa BrachySilTM
trials
for the treatment of pancreatic cancer; failure of the findings of the
pancreatic cancer phase IIa trial to provide a platform for further
multicentre efficacy and safety trials; failure of there to be
optimisation and standardisation between our two pancreatic
cancer study centres; failure of the results of the Retisert™ for DME
trial to be a good indicator of the results of pSivida’s ongoing phase III
Medidur™ for DME trial; failure of the Medidur™ trials in DME to show a very
similar improvement in visual acuity and diabetic retinopathy severity score
as
Retisert™ for DME; failure of Medidur™ to release fluocinolone acetonide at the
same rate as Retisert™; our inability to recruit patients for the phase III
Medidur™ for DME trial. Other reasons are contained in cautionary statements in
the Annual Report on Form 20-F filed with the U.S. Securities and Exchange
Commission, including, without limitation, under Item 3.D, "Risk Factors"
therein. We do not undertake to update any oral or written forward-looking
statements that may be made by or on behalf of pSivida.