Washington,
D.C. 20549
FORM
6-K
REPORT
OF
FOREIGN ISSUER
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For
the month of October 2005
Commission
File Number 000-51122
pSivida
Limited
(Translation
of registrant’s name into English)
Level
12
BGC Centre
28
The
Esplanade
Perth
WA
6000
(Address
of principal executive offices)
(Indicate
by check mark whether the registrant files or will file annual reports under
cover Form 20-F or Form 40-F).
Form
20-F
ý Form
40-F o
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted
by Regulation S-T Rule 101(b)(1):
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted
by Regulation S-T Rule 101(b)(7):
Indicate
by check mark whether the registrant by furnishing the information contained
in
this Form is also thereby furnishing the information to the Commission pursuant
to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes
o No
ý
If
"Yes"
is marked, indicate below the file number assigned to the registrant in
connection with Rule 12g3-2(b): 82- ___.
SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant,
pSivida Limited, has duly caused this report to be signed on its behalf by
the
undersigned, thereunto duly authorized.
| Date: October 31, 2005 | ||
| pSivida Limited | ||
| |
|
|
| By: | /s/ Aaron Finlay | |
|
Aaron
Finlay
|
||
| Chief Financial Officer and Company Secretary | ||
EXHIBIT
INDEX
|
EXHIBIT
99.1:
|
BrachySil™
Phase IIb Clinical Trials for Liver Cancer Commence Following Approval
by
HSA
|
-
2
-
| ASX/MEDIA RELEASE |
 |
|
31
October 2005
|
|
BrachySil™
Phase IIb Clinical Trials for Liver Cancer
Commence Following Approval by HSA
Commence Following Approval by HSA
First
patient in multi-centre dose-profiling study receives treatment in
Singapore
General Hospital after approval by the Health Sciences
Authority
Global
bio-nanotech company pSivida Limited (ASX:PSD, NASDAQ:PSDV, XETRA:PSI) is
very
pleased to announce that Phase IIb clinical trials have commenced with
BrachySil™ (32-P BioSilicon™) as a potential new brachytherapy treatment for
inoperable primary liver cancer (hepatocellular carcinoma, HCC). The first
patient has successfully received treatment at Singapore General Hospital
(“SGH”) using a new fine-gauge needle, multi-injection device which will enable
for the first time, larger and also multiple tumors to be treated. A total
of 50
patients will be entered into this multi-centre trial, which will be conducted
in Singapore, Malaysia and Vietnam.
The
study, which was designed in collaboration with SGH and approved by the
Singaporean regulatory authority (Health Sciences Authority) will determine
the
optimal dose of BrachySil™ in treating inoperable HCC. Patients will be
evaluated up to 12 months after treatment, and the endpoints are based on
evaluations of patient safety and target tumor responses, as well as overall
survival.
The
study
is intended to provide pivotal efficacy and safety data to support future
product registration and approval of BrachySil™ as an effective treatment for
primary liver cancer. These results are expected to build on the findings
of a
Phase IIa study concluded earlier this year on patients with advanced liver
cancer. In this trial, which was also conducted at the SGH, BrachySil™ was found
to be both safe and well tolerated. It was also found to reduce significantly
the size of some tumors treated even on a lower dose as used in the earlier
trials.
In
addition, the Phase IIb trial will include a clinical evaluation of pSivida’s
proprietary SIMPL™ implantation system. SIMPL™ is a fine-gauge needle,
multi-injection device, through which BrachySil™ is injected as a liquid
suspension directly into tumors under local anesthetic. The device has been
designed to ensure the effective distribution of the implanted dose from
a
single entry point and, for the first time, to enable physicians to treat
larger
tumors. This device is expected to be a further significant advantage of
BrachySil™ over existing brachytherapies as well as assist in expanding the
application of BrachySilTM
to other
solid tumour cancers, in addition to pancreatic cancer for which a phase
IIa
trial is currently being planned.
Gavin
Rezos, CEO of pSivida, said, “This is a highly important clinical development
milestone in the programme for the successful commercialization of our
BrachySil™ cancer therapy product. Positive data from this trial is critical to
our future plans for the commercialization of BrachySil™ in this indication for
which we are seeking to file for registration in 2007. We believe that the
encouraging findings in earlier studies will be confirmed and optimized in
this
trial, thus providing both a strong foundation for future regulatory filings
and
a powerful attraction for commercial partners.”
Dr
Pierce
Chow, Lead Investigator and Senior Consultant, Hepatobiliary and General
Surgery
at Singapore General Hospital, said, “We are delighted to continue working with
pSivida on this exciting and important new product. Primary liver cancer
is a
major malignancy and BrachySil™ has so far demonstrated its potential as a safe
and relatively pain-free treatment. With this new trial, we expect to reaffirm
the findings reported previously and bring this innovative product closer
to the
patients who really need it.”
-ENDS-
|
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
|
UK
& Europe Public Relations
Mark
Swallow / Helena Podd
Citigate
Dewe Rogerson
Tel:
+44 (0)20 7638 9571
mark.swallow@citigatedr.co.uk
Singapore
General Hospital
Ms
Angela Ng,
Assistant
Manager, Corporate Communications
Tel:
+ 65 6321 4325
|
NOTES
TO EDITORS:
pSivida
Limited
pSivida
is a global bio-nanotech company committed to the biomedical sector and the
development of products in healthcare. The company’s focus is the development
and commercialisation of a modified form of silicon (porosified or
nano-structured silicon) known as BioSilicon™.
pSivida
owns the intellectual property pertaining to BioSilicon™ for use in or on humans
and animals. The IP portfolio consists of 29 patent families, 34 granted
patents
and over 80 patent applications. The core patent, which recognises BioSilicon™
as a biomaterial was granted in the UK in 2000 and in the US in 2001.
pSivida
is listed on NASDAQ (PSDV),
the
Australian Stock Exchange (PSD)
and in
Germany on the Frankfurt Stock Exchange on the XETRA system (German Symbol:
PSI. Securities Code (WKN) 358705).
pSivida’s shares also trade in the United Kingdom on the OFEX International
Market Service (IMS) under the ticker symbol PSD.
pSivida
is a founding member of the NASDAQ Health Care Index and the Merrill Lynch
Nanotechnology Index.
The
Company's strategic partner and largest shareholder is QinetiQ, a leading
international defence, security and technology company, formed in July 2001
from
the UK Government's Defence Evaluation & Research Agency (DERA).
QinetiQ was instrumental in discovering BioSilicon(TM) and pSivida enjoys
a
strong relationship with it having access to its cutting edge research and
development facilities. For more information on QinetiQ visit www.QinetiQ.com
For
more
information visit www.psivida.com
Singapore
General Hospital
Singapore
General Hospital (SGH) is Singapore’s oldest and largest tertiary acute care
hospital and national referral centre. It offers a comprehensive range of
clinical specialties and support services for the South-East Asia region.
Annually, 70,000 patients are admitted to the hospital and 600,000 attend
its
specialist outpatient clinics. SGH also recognizes research and education
as
essential pillars of healthcare. Drawing upon its wealth of resources (clinical
expertise, modern research facilities, and patient data and specimens), the
Hospital’s researchers are pursuing, in an integrated and holistic manner, the
full range of ‘molecules-to-communities’ studies. Extensive teaching and
educational services are also offered.
For
more
information visit www.sgh.com.sg
Notes
on BrachySil™ and competitive advantages in brachytherapy
BrachySil™
is a micron-sized nanostructured silicon particle in which radioactive
32-phosphorus (32-P) is immobilized. It is administered as a liquid suspension
through a fine-gauge needle directly into tumors. The procedure takes place
under local anaesthetic and without the need for shielded rooms or robotic
injectors, and patients can be discharged the next day.
Brachytherapy
treatment utilising BrachySil™ includes the following potential
advantages:
| · |
Short
range -
32-P isotope has a short active range resulting in controlled exposure
to
radioactivity and less damage to healthy
tissue.
|
| · |
Immobilization
-
32-P device is immobilized in the tumor, significantly reducing risk
of
leakage or systemic side effects.
|
| · |
Ease
of application -
BrachySil™ is delivered under local anaesthetic and patients can be
discharged the next day.
|
| · |
Direct
delivery -
BrachySil™ is delivered via fine-gauge needle, minimizing side effects and
tissue trauma without the need for shielded rooms or robotic injectors
allowing treatment in hospitals without the need for investment in
specialised facilities.
|
| · |
Range
of tumors -
fine-gauge needle delivery allows potential application to many solid
tumors, unlike current brachytherapy
products.
|
| · |
Distribution
-
32-P half-life of 14 days allows convenient distribution to hospitals
and
application in the patient.
|
| · |
Manufacture
-
BioSilicon™ is “radiation hard” allowing ease of manufacture of BrachySil™
from phosphorus-doped silicon used in the electronics industry without
the
need to build costly manufacturing
facilities.
|
This
document contains forward-looking statements that involve risks and
uncertainties. 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
failure to develop applications for BioSiliconTM
due to
regulatory, scientific or other issues. Other reasons are contained in
cautionary statements in the Registration Statement 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.