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 2006
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
x 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
x
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 10, 2006 | ||
| pSivida Limited | ||
| |
|
|
| By: | /s/ Aaron Finlay | |
|
Aaron
Finlay
Company
Secretary
|
||
EXHIBIT
INDEX
|
EXHIBIT
99.1:
|
First
Patient Implanted in European Pancreatic Cancer
Study
|
-2-
| ASX/MEDIA RELEASE |
10
October
2006
|
First
patient implanted in European Pancreatic Cancer Study
Boston,
MA. and Perth, Australia - Global bio-nanotech company pSivida Limited
(ASX:PSD,
NASDAQ:PSDV, Xetra:PSI)
is
pleased to announce that the first patient has been implanted with
BrachySilTM
for the
treatment of inoperable pancreatic cancer at Guys and St Thomas’ NHS Foundation
Trust Hospital in London, a major centre for cancer therapy in the United
Kingdom.
The
treatment delivers BrachySilTM
directly
to a tumor in the pancreas via endoscopic ultrasound (used to assist in locating
the delivery point). BrachySilTM
is a
novel oncology product which comprises a combination of BioSiliconTM
and the
isotope 32Phosphorus, a proven anti-cancer therapeutic. The targeted and
localized nature of the product could potentially provide oncologists with
an
effective and user-friendly treatment for this disease which has a high unmet
clinical need.
Pancreatic
cancer has one of the lowest cancer survival rates (five year relative survival
rate of approximately 5%) with 85-90% of patients being diagnosed with the
inoperable form of the disease. There is significant clinical and market demand
for effective therapies to treat this aggressive form of cancer. According
to
*GLOBOCAN, there were over 230,000 new cases and nearly as many deaths from
pancreatic cancer worldwide in 2002. Approximately 50% of these new cases were
in North America and Europe.
The
primary objective of the six month clinical study is to determine the safety
of
the image-guided implantation of BrachySil™. Efficacy, as determined by
Computerized Tomography scanning of the tumor size and overall survival, will
be
secondary endpoints. The trial is being conducted in both Europe and Asia with
a
second clinical centre at the Singapore General Hospital and the National Cancer
Centre Singapore. The findings will provide a platform for further multicenter
efficacy and safety trials.
Pancreatic
cancer is the second clinical indication for BrachySilTM,
currently in Phase IIb clinical trials for the treatment of inoperable primary
liver cancer. A Phase IIa study in inoperable primary liver cancer was completed
in July 2005 and showed BrachySil™ to be well tolerated. All patients
experienced a decrease in the size of their tumors, with some experiencing
complete tumor regression.
“We
believe that the first trial in man of BrachySilTM
for the
treatment of inoperable pancreatic cancer represents a significant next step
to
bringing an effective treatment for an aggressive cancer that presently has
a
very low survival rate,” said CEO and Executive Chairman of pSivida Limited, Dr
Roger Brimblecombe. “This trial expands our clinical development program for
BrachySil™, our novel oncology product, into an additional solid tumor
indication for which current therapies are very inadequate”.
*GLOBOCAN
is a worldwide database of cancer incidence and
mortality rates.
-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
|
European
Public Relations
Accent
Marketing Limited
Eva
Reuter
Tel:
+49 (254) 393 0740
e.reuter@e-reuter-ir.com
|
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: the failure of the company to successfully close a new issue of
convertible notes; the failure of the Company to obtain the requisite
shareholder approval to issue the new convertible notes; failure to obtain
shareholder approval for the issue of shares underlying the ADS conversion
and
the warrant issues under the new convertible notes; our inability to raise
additional funds at favourable terms or any terms; our inability to repay the
amended notes and new convertible 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
multicenter 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.