-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, C006TBoCl3g2KjzrrIxxgcLO/aYCqoBbOjQxSNtMwuxZvmRXrIdMN2jMb9YzmCJy dYYt4W2Bo7Ayr1tGOEsyzA== 0001144204-05-010867.txt : 20050408 0001144204-05-010867.hdr.sgml : 20050408 20050408062916 ACCESSION NUMBER: 0001144204-05-010867 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20050408 FILED AS OF DATE: 20050408 DATE AS OF CHANGE: 20050408 FILER: COMPANY DATA: COMPANY CONFORMED NAME: pSivida LTD CENTRAL INDEX KEY: 0001314102 STANDARD INDUSTRIAL CLASSIFICATION: LABORATORY ANALYTICAL INSTRUMENTS [3826] IRS NUMBER: 000000000 STATE OF INCORPORATION: C3 FISCAL YEAR END: 0630 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-51122 FILM NUMBER: 05740344 BUSINESS ADDRESS: STREET 1: LEVEL 12 BGC CENTRE STREET 2: 28 THE ESPLANADE CITY: PERTH STATE: C3 ZIP: 6000 BUSINESS PHONE: 61 8 9226 5099 MAIL ADDRESS: STREET 1: LEVEL 12 BGC CENTRE STREET 2: 28 THE ESPLANADE CITY: PERTH STATE: C3 ZIP: 6000 6-K 1 v016007_6k.htm
 
SECURITIES AND EXCHANGE COMMISSION
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 April 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: April 8, 2005    
  pSivida Limited
 
 		  
 		  
 
By:   /s/ Aaron Finlay
 
Aaron Finlay
  Chief Financial Officer and Company Secretary
 

 

 
EXHIBIT INDEX
 
EXHIBIT 99.1:
pSivida Expands Market for Lead Cancer Product BrachySilTM
   

 
 
 
 
-2-
 EX-99.1 2 v016007_ex99-1.htm




ASX/MEDIA RELEASE 
8th April 2005
        
pSivida Expands Market for Lead
Cancer Product BrachySilTM
Pancreatic Cancer - Significant Unmet Clinical Need

Global nanotechnology company pSivida Limited (ASX:PSD, NASDAQ:PSDV, Xetra:PSI) is pleased to announce that it has initiated a full development programme of its proprietary BrachySilTM product in a second key cancer indication. Development has commenced to evaluate the efficacy and safety of this novel brachytherapy product in pancreatic cancer, with the clinical programme scheduled to commence before the end of 2005.

Selection of this second key indication has resulted from significant independent market research and medical opinion leader feedback and therefore represents a judicious, robust and viable development option.

Pancreatic cancer is one of the most prevalent cancers with over 232,000 new cases on a global basis per annum (Globocan 2002 statistics) and approximately 60% of new cases occurring in the developed world. With an average five year survival of 4%, pancreatic cancer represents a significant unmet clinical need. 

BrachySilTM is a micron-sized particle in which the isotope 32-phosphorus is immobilised. pSivida believes that this product is unique in that it demonstrates a very high degree of isotope retention, thus reducing the risk of radioactivity effecting healthy hepatic tissue or entering the circulation and causing systemic toxicity.

The clinical programme currently being conducted in primary liver cancer has provided significant data demonstrating the product’s safety, efficacy (up to 100% tumor regression in some cases for smaller tumors) and the ease of administration via a fine gauge needle injection procedure. The ability of BrachySil™ to remain at the injection site has been another significant outcome of the trials. Multi-centre pivotal registration trials are scheduled to commence during 2005 to provide data to support registration of BrachySil™ as an approved treatment for primary liver cancer.

pSivida’s managing director Mr. Gavin Rezos said “This additional advanced development programme for BrachySilTM follows the successful completion of the initial phase of clinical evaluation for the product in primary liver cancer and is in line with our strategy to expand and maximise the market potential of this unique approach to cancer therapy. This second significant development programme will benefit enormously from the strong foundation of pharmaceutical, manufacturing and clinical experience already available for BrachySilTM, and therefore reduces risk in the pathway to regulatory approval and commercialisation.”

-ENDS-
 

Released by:
  
   
In Australia:
In US:
Josh Mann, CFA
Beverly Jedynak
Investor Relations
President
pSivida Limited
Martin E. Janis & Company, Inc.
Tel: + 61 8 9226 5099
Tel: 312-943-1100 ext. 12
joshuamann@psivida.com
bjedynak@janispr.com
 

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 24 patent families, 26 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

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.
 
 
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