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
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
For
the month of June 2005
Commission
File Number 000-51122
pSivida
Limited
(Translation of registrant’s name into English)
(Translation of registrant’s name into English)
Level
12
BGC Centre
28 The Esplanade
Perth WA 6000
(Address of principal executive offices)
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.
| pSivida Limited | ||
| |
|
|
| Date: June 21, 2005 | By: | /s/ Aaron Finlay |
|
|
||
| Aaron
Finlay Chief Financial Officer and Company Secretary |
||
EXHIBIT
INDEX
|
EXHIBIT
99.1:
|
BrachySil™
Cancer Therapy Achieves Primary Endpoint in Phase IIa Clinical
Trials
|
-2-
 |
|
| ASX/MEDIA RELEASE |
21st June
2005 |
BrachySil™
Cancer Therapy Achieves Primary Endpoint
in
Phase IIa Clinical Trials
Final
Report Confirms BrachySil™ Safe and Well
Tolerated
Global
nanotechnology company pSivida Limited (ASX:PSD,
NASDAQ:PSDV, XETRA:PSI) and the
Singapore General Hospital (“SGH”), are very pleased to announce key
findings from the final report on its Phase IIa clinical trials with
BrachySil™ as a potential new brachytherapy treatment for inoperable
primary liver cancer.
The
report confirms that the primary endpoint of the trial was achieved in its key
first indication in that BrachySil™ (32-P BioSilicon™) was found to
be both safe and well tolerated. The trial was conducted at the SGH on eight
patients with advanced liver cancer who were evaluated after three and six
months following treatment.
Among
other key findings of the trial was the finding that BrachySil™
also reduced significantly the size of tumors treated as determined by CT
scanning. These combined results pave the way for a multi-centre Phase IIb
dose-profiling study for BrachySil™ in this indication, which is scheduled
to begin later in 2005. This study is expected to provide data to support the
registration of BrachySil™ as an approved treatment for liver cancer.
Gavin
Rezos, Managing Director of pSivida, said, “This report confirms the
excellent results for BrachySil™ that we previously announced at the
12-week interim study time point, and will provide not only a robust foundation
for future clinical development and regulatory filing, but also a springboard
for our ongoing licensing activities with partners looking to enhance their own
portfolios of specialist cancer therapies.”
Dr
Pierce Chow, Senior Consultant, Hepatobiliary and General Surgery at Singapore
General Hospital, said, “From the perspective of patients suffering with
advanced cancer of this kind, BrachySil™ promises to offer the possibility
of an effective, safe and relatively pain-free treatment, which can potentially
improve both the duration and quality of life. We, at the SGH, are very
encouraged by the promising data seen to date with BrachySil™ and are
optimistic that subsequent clinical trials will continue to show positive
results in this and other serious cancer indications.”
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.
Key
Findings
The
final report of the Phase IIa clinical trial has confirmed four
key
findings:
| · |
Safety
- No product-related adverse events
BrachySil™ was found to be well tolerated
by all eight patients in the trial group. No significant product-related
adverse events were reported either immediately following implantation or
during the six month follow-up period. Adverse events tended to be mild and
transient. |
| · |
Efficacy
- Treated tumors demonstrate significant tumor
regression
Implanting BrachySil™ directly into tumors
results in significant tumoricidal activity. 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 three and six months later
demonstrates significant tumor regression in targeted lesions with a maximum
regression of 100% in some small tumors from the dose used in the
trial. |
| · |
Specificity
- Retention of radioactivity in the tumor
A key finding is that BrachySil™
microparticles remain in the tumor with no or insignificant detectable
radioactive leakage. This observation is a very significant outcome for the
trial. Unlike other liver brachytherapy approaches that involve delivery via
the hepatic artery which, in some cases, results in radioactivity becoming
associated with healthy tissue, BrachySil™ is administered directly into
tumors restricting radioactivity to the tumor itself. |
| · |
Ease
Of Application - Practical and rapid treatment of tumors with ultrasound and CT
guidance
The procedure has been shown to be
straightforward and accurate for the treatment of tumors in a routine and
conventional clinical setting. From a market perspective, this demonstration is
in line with the Company’s strategy to develop a simple procedure for the
nuclear medicine physician and interventional radiologist to selectively treat
specific tumors. |
Next
Steps
As
mentioned above, pSivida is planning to initiate a multi-centre Phase IIb
dose-profiling study for BrachySil™ as a treatment for advanced liver
cancer in the second half of 2005.
The
Company plans to pursue a ‘device-based’ regulatory strategy, with
BrachySil™ filings scheduled in 2007 initially as a treatment for liver
cancer and thereafter for the treatment for other cancers involving solid
tumors.
pSivida
has already started a development programme for BrachySil™ in a second key
cancer indication - pancreatic cancer - and plans to commence Phase IIa
clinical trials before the end of 2005 to evaluate and safety and tolerability
of the treatment. The trial will also monitor the efficacy of the treatment
based on CT measurements of tumor regression as a foundation for subsequent
Phase IIb dose-profiling studies.
Finally,
pSivida will employ a multi-injector/implanter device that will be clinically
evaluated in all subsequent trials using BrachySil™ as a means of ensuring
effective distribution of the implanted dose from a single entry point. This
device will, for the first time, enable physicians to treat larger tumors and
could represent a significant advantage of BrachySil™ over existing
brachytherapies. The Company is currently seeking development and marketing
partners for BrachySil™ in the major territories.
Notes
on BrachySil™ and competitive advantages in brachytherapy
BrachySil™
(32-P-BioSilicon™) is being manufactured to regulatory guidelines by
supply chain contract partners including Atomising Systems Ltd and High Force
Ltd in the UK and Auriga Medical in Germany. Importantly the manufacturing
process has already been scaled up successfully to supply materials for
clinical trial programmes and early product launch.
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. |
-ENDS-
For
further information, please contact:
|
pSivida
Limited
Gavin
Rezos, Managing Director
Joshua
Mann, CFA, Investor Relations |
Tel: +
61 (8) 9226 5099 |
|
Singapore
General Hospital
Ms
Angela Ng,
Assistant
Manager, Corporate Communications |
Tel: +
65 6321 4325 |
|
US
Public Relations
Beverly
Jedynak, Martin E. Janis & Co. |
Tel: +1
(312) 943 1100 |
|
UK
& Europe Public Relations
Mark
Swallow, Ph.D, Citigate Dewe Rogerson |
Tel: +44
(0)20 7638 9571 |
NOTES
TO EDITORS:
pSivida
Limited
pSivida
is a global nanotechnology 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™. As a new and exciting
biocompatible material, BioSilicon™ offers multiple potential applications
across the high growth healthcare sector, including controlled release drug
delivery, targeted cancer therapies (including brachytherapy and localized
chemotherapy), tissue engineering and orthopedics. Potential diagnostics
applications are being developed through its subsidiary AION Diagnostics
Limited.
pSivida
owns the intellectual property rights to BioSilicon™ for use in or on
humans and animals. The IP portfolio consists of 26 patent families, 30 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.
The
Company’s strategic partner and largest shareholder is the QinetiQ group,
the largest science and technology company in Europe. QinetiQ is the former UK
government Defence Evaluation Research Agency and was instrumental in
discovering BioSilicon™. pSivida enjoys a strong relationship with QinetiQ
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
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.