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 August 2007
Commission
File Number 000-51122
pSivida
Limited
(Translation
of registrant’s name into English)
Level
12 BGC Centre
28
The Esplanade
Perth
WA 6000
Australia
(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- ___.
The
document attached as Exhibit 99.1 to this Report on Form 6-K is hereby
incorporated by reference herein and into the following registration statements:
(i) the Registrant's Registration Statement on Form F-3, Registration
No. 333-132776; (ii) the Registrant's Registration Statement on
Form F-3, Registration No. 333-132777; (iii) the Registrant's
Registration Statement on Form F-3, Registration No. 333-135428; (iv)
the Registrant's Registration Statement on Form F-3, Registration
No. 333-141083; (v) the Registrant's Registration Statement on
Form F-3, Registration No. 333-141091; and (vi) the Registrant's
Registration Statement on Form F-3, Registration
No. 333-143225.
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:
August
13, 2007
| PSIVIDA LIMITED | ||
| |
|
|
| By: | /s/ Michael J. Soja | |
|
Michael J. Soja |
||
| Vice President, Finance and Chief Financial Officer | ||
EXHIBIT
INDEX
|
EXHIBIT
99.1:
|
ASX
Release: pSivida completes recruitment of European Pancreatic Cancer
Study
and
releases preliminary
findings
|
| ASX/Media RELEASE |
13
August
2007
|
pSivida
completes recruitment of European
Pancreatic
Cancer Study
and
releases preliminary findings
Boston,
MA and Perth, Australia (August 13, 2007) - pSivida Limited (NASDAQ:PSDV,
ASX:PSD, Xetra:PSI) today announced the completion of the recruitment stage
of
the Phase IIa clinical study of BrachySilTM
for the
treatment of inoperable pancreatic cancer at three leading hospitals in the
United Kingdom and Singapore. All are major centers for cancer
therapy.
A
total
of 17 patients were treated with BrachySilTM
directly
to a tumor in the pancreas via endoscopic ultrasound (used to assist in locating
the delivery point), in combination with standard chemotherapy.
BrachySilTM
is a
novel oncology product which consists of a combination of BioSiliconTM
and the
isotope 32Phosphorus, a proven anti-cancer therapeutic, and is intended to
be
used in conjunction with standard chemotherapy for enhanced tumor response.
BrachySilTM
is
designed to be a targeted and localized product and could potentially provide
oncologists with an effective and user-friendly treatment for this disease
which
has a high unmet clinical need.
We
believe the preliminary data are very encouraging. Eight weeks follow-up data
available on the first 10 patients treated shows 90% of these patients have
had
either stabilization or reduction in size of their primary tumor and none of
these patients experienced product related significant adverse
events.
The
primary objective of this 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 are secondary endpoints.
Preliminary data on the balance of the patients treated will be released when
a
minimum of eight weeks follow-up data have been obtained. The first analysis
of
all the patients is expected to be available at the end of the calendar year
and
results will be used to guide future studies.
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 which is the
fourth leading cause of death by cancer in the United States.
“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 Managing Director of pSivida Limited, Dr Paul
Ashton.
-ENDS-
Released
by:
|
pSivida
Limited
Brian
Leedman
Vice
President, Investor Relations
pSivida
Limited
Tel:
+ 61 8 9226 5099
bleedman@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
Eva
Reuter
Accent
Marketing Limited
Tel:
+49 (254) 393 0740
e.reuter@dr-reuter.eu
|
NOTES
TO EDITORS:
pSivida
is a global drug delivery company committed to the biomedical sector. Retisert®
is FDA approved for the treatment of uveitis. Vitrasert® is FDA approved for the
treatment of AIDS-related CMV Retinitis. Bausch & Lomb owns the trademarks
Vitrasert® and Retisert®. pSivida has licensed the technologies underlying both
of these products to Bausch & Lomb. The technology underlying Medidur™ for
diabetic macular edema is licensed to Alimera Sciences and is in Phase III
clinical trials. pSivida has a worldwide collaborative research and license
agreement with Pfizer Inc. for other ophthalmic applications of the Medidur™
technology.
pSivida
owns the rights to develop and commercialize a modified form of silicon
(porosified or nano-structured silicon) known as BioSilicon™, which has
applications in drug delivery, wound healing, orthopedics, and tissue
engineering. The most advanced BioSilicon™ product, BrachySil™ delivers a
therapeutic, P32 directly to solid tumors and is presently in Phase II clinical
trials for the treatment of pancreatic cancer.
pSivida’s
intellectual property portfolio consists of 71 patent families, 99 granted
patents, including patents accepted for issuance, and over 300 patent
applications. pSivida conducts its operations from facilities near Boston in
the
United States, Malvern in the United Kingdom and Perth in
Australia.
pSivida
is listed on NASDAQ (PSDV),
the
Australian Stock Exchange (PSD)
and on
the Frankfurt Stock Exchange on the XETRA system (PSI).
pSivida is a founding member of the NASDAQ Health Care Index and the Merrill
Lynch Nanotechnology Index.
This
release contains forward-looking statements that involve risks and uncertainties
including with respect to the efficacy of pSivida’s drug delivery technology,
potential
products, the potential size of certain markets, our ability to continue to
raise funds
and
the
final
results of the Phase IIa clinical study of BrachySil for the treatment of
inoperable pancreatic cancer.
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: failure
of the preliminary data of the Phase IIa pancreatic cancer trial to be
indicative of final results, the risk that use of BrachySil in conjunction
with
standard chemotherapy does not enhance tumor response; failure of BrachySil
to
provide oncologists with an effective and user-friendly treatment for inoperable
pancreatic cancer; failure of the Company to conduct any future BrachySil trials
or studies. 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.