Preclinical Data for a Topical Formulation of Voclosporin as a Potential Best-in-Class Treatment for Chronic Inflammatory Eye Diseases Presented at ARVO
EDMONTON, Alberta, July 31, 2008 /CNW/ - (ISA:TSX): Isotechnika Inc. today announced that its partner, Lux Biosciences, presented preclinical data demonstrating the safety and pharmacokinetics of LX214 as a potential once-daily topical treatment for chronic inflammatory diseases of the eye. LX214 is a clear, micellar topical formulation of voclosporin, Isotechnika's next-generation calcineurin inhibitor, which is being developed by Lux Biosciences as a
potential treatment for such conditions as dry eye syndrome, blepharitis, and atopic keratoconjunctivitis.
Lux Biosciences researchers and collaborators presented the data in a poster session at the ARVO Summer Eye Research Conference, "Ocular Immunity
and Inflammation" being held from July 31 - August 2 at the Portola Plaza Hotel in Monterey, CA. Highlights of the data included:
- Concentrations of voclosporin established therapeutic levels in tear
fluid and most ocular tissues after single or multiple topical
applications of LX214. Blood levels remained at or near base line,
and there was minimal distribution of voclosporin to the opposite,
non-treated eye indicating no systematic exposure to the drug.
- Tissue concentrations of voclosporin in the target tissues were
significantly higher than the tissue concentrations of cyclosporine A
achieved by twice daily topical application of Restasis(R)
(cyclosporine 0.05%) suggesting greater efficacy over Restasis(R) and
the potential for once-a-day dosing.
- These results are particularly important given that voclosporin has
been shown to be four-fold more potent than cyclosporine A.
- No evidence of clinical irritation or melanin binding was observed in
any of the animals treated with LX214.
"These data strongly support the further development of LX214 as a topical product for serious ocular inflammatory conditions as well as for dry
eye syndrome," said Ulrich Grau, Ph.D., President and Chief Executive Officer of Lux Biosciences. "We believe that the product has best-in-class potential
based on the preclinical findings."
Edmonton-based Isotechnika Inc. is an international 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 is a next generation calcineurin inhibitor, which recently completed a Phase 2b North American trial for the prevention of kidney rejection following transplantation. An extension to the Phase 2b trial and a combined Phase 3 European/Canadian trial for the treatment of moderate to severe psoriasis are ongoing. Our partner, Lux Biosciences, is currently conducting three separate Phase 2/3 pivotal trials investigating voclosporin (referred to as LUVENIQTM by Lux) for the treatment of uveitis. 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 Inc. is a publicly traded company on the Toronto Stock Exchange under the symbol "ISA". More information on Isotechnika can be found
at www.isotechnika.com or www.SEDAR.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 patents from infringement by third
parties, and the risk that the Company's patents 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.
/For further information: Robert Foster, Chairman & CEO, Isotechnika
Inc., Phone: (780) 487-1600 (x247), Fax: (780) 484-4105, E-mail:
firstname.lastname@example.org; Stephanie Gillis-Paulgaard, Director, Communications,
Isotechnika Inc., Phone: (780) 909-4661, Fax: (780) 484-4105, E-mail:
Posted: August 2008