-- Partner Lux Biosciences Preparing to File for US and European
EDMONTON, Oct. 27 /CNW/ - Isotechnika Pharma Inc. (TSX:ISA) today announced that results of the international Phase 2/3 clinical trials studying voclosporin, conducted by its partner Lux Biosciences, were the subject of two podium presentations at the American Association of Ophthalmology (AAO) meeting and of a presentation at the satellite meeting of the American Uveitis Society (AUS) in San Francisco, October 24-27. The presentations highlighted the ability of voclosporin (LX211, LUVENIQ(TM)) to control the inflammation that characterizes this potentially blinding eye disease and significantly reduce its rate of recurrence. Isotechnika's partner, Lux Biosciences, plans to file a New Drug Application (NDA) and a Marketing Authorization Application (MAA) for marketing approvals around year-end 2009 and early 2010 in the United States and Europe, respectively, making it possible for voclosporin to become the first approved oral treatment capable of modifying the course of uveitis, a group of serious eye conditions frequently associated with either severe vision loss or substantial morbidity from steroid use.
"I am very impressed with the results and excited about Lux Biosciences' rapid march towards commercialization with our drug, voclosporin," said Dr. Robert Foster, President and CEO of Isotechnika Pharma. "Moreover, these findings support the safety profiles we have observed in Isotechnika's psoriasis and kidney transplant studies, and are something Isotechnika stakeholders will see bearing fruit as Lux continues advancing towards voclosporin's first FDA approval and expected subsequent launch."
- Professor Bahram Bodaghi, M.D., Ph.D., Pitié Salpétrière Hospital
Paris, France, presented study results from the LX211-02 study on
Monday, October 26 at 8:50 am PT at the AAO;
- Dr. Quan D. Nguyen, M.D., of the Wilmer Eye Institute at The Johns
Hopkins University, Baltimore, MD, presented study results from the
LX211-01 study on Monday, October 26 at 9:00 am PT at the AAO;
- Dr. C. Stephen Foster, MD, President, Massachusetts Eye Research and
Surgery Institution (MERSI), presented on the ability of voclosporin
to control inflammation and to significantly delay recurrence of
inflammatory exacerbation compared to the control group at AUS on
Sunday, October 25 at 8:00 pm PT.
"The LX211-02 study was a double-masked, placebo-controlled, dose-ranging study that included 232 patients at 57 centers in North America, Europe and India with clinically inactive uveitis involving any location within the eye," said Professor Bodaghi. "Results of this trial showed that LX211 was able to reduce recurrence of inflammation by 50% over placebo at the 0.4 mg/kg twice daily dose - a p-value of less than 0.05 - and may therefore effectively increase the interval between inflammatory relapses to 24 months compared to 10 months with placebo."
Professor Bodaghi also commented that, "Given that inflammatory exacerbation is a direct trigger of vision loss, this result for LX211 is impressive. In addition to a marked reduction in recurrence of inflammation, visual acuity was preserved in this study. Moreover, these results suggest the potential for disease modification whereby treatment with LUVENIQ alters the course of the disease leading ultimately to improved outcomes in this difficult-to-treat condition."
"Non-infectious uveitis involving the posterior segment of the eye is a leading cause of vision loss and long-term disability and the fourth leading cause of legal blindness in the industrialized world," said Ulrich Grau, Ph.D., Lux Biosciences' President and CEO. "As the majority of patients are first diagnosed at ages under 40 years, the socio-economic burden of uveitis is higher than that of other serious ocular conditions such as AMD and diabetic macular edema. The results from these clinical trials suggest that LX211 may have the potential to significantly change the face of uveitis therapy, based on its ability to modify the course of the disease. This is analogous to the advent of disease-modifying anti-rheumatic drugs (DMARDs) and their impact on the course of rheumatoid arthritis."
For more information about uveitis, its incidence, and how the disease is currently treated, please see http://www.luxbio.com/Uveitis%20Backgrounder.pdf.
About Isotechnika Pharma
Edmonton-based Isotechnika Pharma Inc. is a biopharmaceutical company focused on the discovery and development of novel immunosuppressive therapeutics that are designed to offer advantages over other currently available treatments. There is a significant unmet medical need in the treatment of both solid organ transplantation and autoimmune disease. It is estimated that the market potential will exceed $4 billion annually in sales for calcineurin inhibitors such as voclosporin by 2010.
Voclosporin, Isotechnika's lead drug candidate, is a next generation calcineurin inhibitor. It has completed a Phase 2b study for the prevention of kidney rejection following transplantation and a Phase 3 European/Canadian trial for the treatment of moderate to severe psoriasis. Through our partner, Lux Biosciences, our data with voclosporin is being submitted for an NDA in the United States and an MMA in Europe for the treatment of uveitis and is beginning a Phase 1 trial using their proprietary voclosporin ophthalmic solution (LX214) as a candidate for dry eye syndrome. Voclosporin has also entered First-in-Man trials as the drug utilized in the CINATRA(TM) Drug Coated Coronary Stent system developed by the Company's partner, Atrium Medical Corporation.
Isotechnika Pharma Inc. is a publicly traded company on the Toronto Stock Exchange under the symbol "ISA". More information on Isotechnika Pharma can be found at www.isotechnika.com or www.SEDAR.com.
About Isotechnika's Partner, Lux Biosciences
Lux Biosciences, Inc. is a privately held biotechnology company focused on the treatment of ophthalmic diseases. Its submission stage project LUVENIQ (LX211) is the oral formulation of a next-generation calcineurin inhibitor (voclosporin) for which positive phase 3 data have recently been obtained for the treatment of sight-threatening non-infectious uveitis. Lux Biosciences is collaborating with the team at Isotechnika Pharma who invented the molecule and is developing it for other ophthalmic indications. The Company has several earlier stage projects based on its mixed nanomicellar ocular formulation technology, and based on its proprietary product-enabling bio-erodible polymer technologies that facilitate targeted and sustained delivery of molecules to the eye.
Lux Biosciences announced on October 19, 2009 that it closed a $50 million Series B venture financing. This financing will provide funds for Lux Biosciences beyond the anticipated 2010 US-approval for LUVENIQ(TM) and the preparation for commercial launch of that product for non-infectious uveitis.
For more information on Lux Biosciences, please visit the company's website at http://www.luxbio.com.
This press release may contain forward-looking statements. Forward looking statements, including the Company's belief as to the potential of its products, the Company's expectations regarding the issuance of additional patents and the Company's ability to protect its intellectual property, involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the ability to economically manufacture its products, the potential of its products, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize its products, the ability of the Company to defend its intellectual property rights from infringement by third parties, and the risk that the Company's intellectual property rights may be subsequently shown to be invalid or infringe the patents of others. Investors should consult the Company's quarterly and annual filings with the Canadian commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements.
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For further information: For further information: Dr. Robert Foster, President & CEO, Isotechnika Pharma Inc., (780) 487-1600 (247), (780) 484-4105 (fax), firstname.lastname@example.org; Mr. Dennis Bourgeault, Chief Financial Officer, Isotechnika Pharma Inc., (780) 487-1600 (226), (780) 484-4105 (fax), email@example.com