Protox Therapeutics signs manufacturing agreement with Waisman


    BioManufacturing Facility in Wisconsin
    TSX-V:PRX


VANCOUVER, Oct. 7 /CNW/ - Protox Therapeutics Incorporated ("Protox")
today announced that it has entered into a manufacturing agreement with the
Waisman Clinical BioManufacturing Facility (WCBF) at the University of
Wisconsin-Madison to manufacture clinical batches of PSA-PA1, its lead product
in development for the treatment of localized prostate cancer. Production of
PSA-PA1 under Good Manufacturing Practice (cGMP) conditions will be a
requirement when the Company files an Investigational New Drug (IND)
application with the United States FDA by mid-2005 to initiate Phase I Human
trials. 
"Protox is planning to file an Investigational New Drug application with
the FDA for PSA-PA1, our lead product in development as soon as possible in
order to proceed with Phase I Human Trials. We are keen to move forward with
our planned progressive research to demonstrate, both in further pre-clinical
trials and in later human trials, the unique potential of our technology in
treating localized prostate cancer," said Dr. Tom Buckley, Chief Scientific
Officer of Protox. "WCBF appears to be most suited to produce our lead product
in development within our budget and timelines. This contract work, along with
our recently announced CTBR agreement to conduct expanded pre-clinical trials
(August 17, 2004) are key major milestones which will keep our aggressive
development plans on track." 
"This is a very exciting project for our facility and we are confident in
our ability to produce PSA-PA1 in a timely and cost effective manner," said
Derek Hei, Technical Director at the WCBF, (formerly Director of Biomedical
Engineering at Cerus Corp.). We are very impressed with the scalable
manufacturing process that the Protox scientists have developed for the
production of PSA-PA1." 
ABOUT THE WAISMAN CLINICAL BIOMANUFACTURING FACILITY: The Waisman
Clinical BioManufacturing Facility (WCBF) is a state-of-the-art facility that
is equipped with experienced staff and specialized equipment that are
necessary for producing experimental human biotherapeutics in compliance with
the FDA (cGMP) requirements. The WCBF is designed to manufacture clinical-grade biological pharmaceuticals for early stage (Phase I and Phase II) human
clinical trials. Located at the University of Wisconsin-Madison's Waisman
Center, the WCBF also provides services to UW-Madison investigators and their
external collaborators in advancing cutting-edge experimental therapeutics
from basic research to testing in human clinic trials. For more information
visit their website www.gmpbiomanufacturing.org. 
ABOUT PROTOX: Protox Therapeutics Inc. has developed, and has licensed
from third parties, technologies intended to transform the naturally occurring
bacterial toxin, Aerolysin, into novel, cancer therapeutics. Once altered
using Protox' proprietary technology, Aerolysin has demonstrated the ability
to target and kill cancer cells by forming holes in their membranes while
leaving healthy 'bystander' cells intact. The Company anticipates that this
approach will produce therapeutics that may have greater efficacy and lower
side effects than current methods of treating cancer. 
The TSX Venture Exchange has not reviewed and does not accept
responsibility for the adequacy or accuracy of the content of this News
Release. This News Release contains forward-looking statements about Protox's
future drug research and development plans, which statements can be identified
by the use of forward-looking terminology such as "planned", "to proceed",
"move forward", "to demonstrate", "potential", "to produce", "development",
"designed to", or the negative thereof or any other variations thereon or
comparable terminology referring to future events or results. Forward-looking
statements are statements about the future and are inherently uncertain, and
Protox's actual results could differ materially from those anticipated in
those forward-looking statements as a result of numerous factors, including
without limitation, uncertainty as to whether Protox's products will be
further developed and marketed successfully as a drug or at all; the fact that
results from preclinical studies may not be predictive of results obtained in
clinical trials; the need for regulatory approvals prior to undertaking
clinical trials and prior to marketing a final product, which approvals may
not be obtained on acceptable terms or at all; uncertainty as to whether
Protox will file an IND by mid-2005 or at all; the fact that Protox is
currently negotiating licenses from third parties necessary to market its
product, which licenses may not be obtained upon acceptable terms or at all,
including a license of the technology on which its product PSA-P1A is based;
the fact that Protox will be required to undertake additional pre-clinical
studies before it will be able to proceed to clinical trials and there can be
no assurance regarding the timing or outcome of such studies, whether the
results of such studies will enable the Protox to proceed with clinical
trials, or as to the timing or outcome of any clinical trials; general
research and development risks; the risk of technical obsolescence; product
liability risks; insurance risks; manufacturing risks and the need to
manufacture to regulatory standards; the effect of competition; the risk of
adverse side effects; intellectual property risks; the need for additional
capital, the availability of which is not assured; changes in business
strategy or development plans; the dependency of Protox on key personnel;
uncertainty as to future market size and market acceptance of Protox's
products; and partnership/strategic alliance risks; as well as a description
of other risks and uncertainties affecting Protox and its business, as
contained in news releases and filings with regulatory authorities, any of
which could cause actual results to vary materially from current results or
Protox's anticipated future results. Forward-looking statements are based on
the beliefs, opinions and expectations of Protox's management at the time they
are made, and Protox does not assume any obligation to update its forward-looking statement if those beliefs, opinions or expectations, or other
circumstances should change. 
-0-                           10/07/2004 
/For further information: regarding Protox, contact: Terry Vanderkruyk, 
Director, Investor Relations, Protox Therapeutics Inc., Tel: (604) 688-4376, 
Cell: (604) 789-0844, Fax: (604) 688-0173, 
tvanderkruyk(at)protoxtherapeutics.com/ 
(PRX.) 
CO:  Protox Therapeutics Inc.
ST:  British Columbia
IN:  MTC 
SU:  CON  
-30- 
-0- Oct/07/2004 12:00 GMT
 
 
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