VANCOUVER, June 17 /CNW/ - Protox Therapeutics Inc. (TSX: PRX - News), 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.
About Protox
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
James Beesley, Director, Investor Relations, Protox Therapeutics, (604) 484-0975, jbeesley@protoxtherapeutics.com Michael Moore, Investor Relations, Equicom Group, (416) 815-0700 x 241, mmoore@equicomgroup.com
Source: Protox Therapeutics Inc.
