VANCOUVER, June 17 /CNW/ - Protox Therapeutics Inc. (TSX: PRX), a leader
in the development of receptor targeted fusion proteins, announced today that
following a positive opinion from the European Medicines Evaluation Agency's
("EMEA") Committee for Orphan Medicinal Products ("COMP"), the European
Commission has granted Orphan designation to PRX321 for the treatment of
glioma, a terminal brain cancer for which there is no known cure.
"The orphan drug designation in the EU signifies a very important step
for Protox in the development of PRX321," said Dr. Fahar Merchant, President
and CEO of Protox. "We appreciate the EMEA's recognition of our efforts and
investment to bring PRX321 forward for the potential benefit of patients with
this devastating form of brain cancer. Orphan designation provides us with
important benefits, both in the preparation for a marketing application and
also commercially for providing market exclusivity for our technology."
In addition to the 10 year market exclusivity, incentives relating to the
designation include assistance from the EMEA in developing a protocol to
maximize the chance of success in achieving market authorization. Other
incentives include direct access to the centralized procedure for the
marketing authorization application process, potential fee reductions relating
to the application for marketing authorization, and eligibility for grants
from the European Union and member states supporting research and development.
PRX321 is a novel targeted protein in which a cytokine, interleukin-4
(IL-4), is linked to a Pseudomonas exotoxin, a potent substance that
selectively kills cancer cells. A single treatment of PRX321 has demonstrated
promising signs of therapeutic activity in patients with highly aggressive
forms of brain cancer in clinical studies performed at leading centres in the
USA and Germany.
Protox is on target to initiate a pre-pivotal Phase 2b clinical trial of
PRX321, in the second half of 2008, for the treatment of recurrent
glioblastoma multiforme (GBM), the most fatal form of brain cancer.
Protox Therapeutics is a leader in advancing novel, receptor targeted
fusion proteins. Two novel drug candidates derived from the company's
INxin(TM) and PORxin(TM) platforms are being developed in three clinical
programs. A Phase 2a clinical trial evaluating PRX321 (INxin) for the
treatment of primary brain cancer has been completed and the drug has received
Fast Track Designation and Orphan Drug Status from the US FDA. Phase 2a
clinical trials evaluating PRX302 (PORxin) for the treatment of localized
prostate cancer and benign prostatic hyperplasia (enlarged prostate) have also
been initiated. Protox is also collaborating with the U.S. National Institutes
of Health (NIH) on a research program focused on the discovery of next
generation fully human targeted therapeutics.
Certain statements included in this press release may be considered
forward-looking. Such statements involve known and unknown risks,
uncertainties and other factors that may cause actual results, performance or
achievements to be materially different from those implied by such statements,
and therefore these statements should not be read as guarantees of future
performance or results. All forward-looking statements are based on Protox'
current beliefs as well as assumptions made by and information currently
available to Protox and relate to, among other things, anticipated financial
performance, business prospects, strategies, regulatory developments, market
acceptance and future commitments. Readers are cautioned not to place undue
reliance on these forward-looking statements, which speak only as of the date
of this press release. Due to risks and uncertainties, including the risks and
uncertainties identified by Protox in its public securities filings; actual
events may differ materially from current expectations. Protox disclaims any
intention or obligation to update or revise any forward-looking statements,
whether as a result of new information, future events or otherwise.
For further information:
For further information: James Beesley, Director, Investor Relations,
Protox Therapeutics, (604) 484-0975, firstname.lastname@example.org; Michael
Moore, Investor Relations, Equicom Group, (416) 815-0700 x 241,