Isotechnika's Partner Initiates First-in-Man Study of LX214 (Voclosporin Ophthalmic Solution) As a Candidate for Dry Eye Syndrome



    EDMONTON, Feb. 17 /CNW/ - (ISA:TSX): Isotechnika Inc. announced today
that its partner, Lux Biosciences, has begun treating patients in a
First-in-Man (Phase 1) study with LX214, a proprietary topical ophthalmic
solution containing voclosporin as the active ingredient. Lux is developing
LX214 as a potential treatment for keratoconjunctivitis sicca, commonly known
as dry eye syndrome (DES), and other chronic inflammatory ocular surface
diseases.
    "We are pleased with the progress of our program for LX214, which we
advanced from inception into the clinic in 18 months, in parallel with our
LX211 and LX201 phase 3 development programs," said Dr. Ulrich Grau, Lux
Biosciences' President and Chief Executive Officer.
    He noted that LX214 is a unique product that, based on preclinical data,
is differentiated from the benchmark therapy by
    
    -  much higher drug levels in target tissues in the eye,
    -  the lack of irritation, and
    -  24-hour therapeutic drug levels in the eye providing a rationale for
       once-a-day dosing.
    

    "These features suggest that LX214 may demonstrate advantages over other
treatment approaches in the very large dry eye indication," Dr. Grau
commented.
    "Initiating clinical trials for dry eye syndrome is very exciting as it
represents the fifth indication for voclosporin," stated Dr. Robert Foster,
Isotechnika's President and Chief Executive Officer. "And, we are pleased with
the rapid progress that Lux has made with voclosporin and look forward to
release of the results of their Phase 2/3 uveitis clinical trial program."
    LX214 is a proprietary formulation and has been developed for topical
ophthalmic use in collaboration with Professor Ashim Mitra at the University
of Missouri, Kansas City. Unlike other topical dry eye products and product
candidates with a similar mechanism of action, LX214 is a crystal clear,
aqueous, mixed micellar formulation. In addition to the unique features of the
formulation, LX214 contains a high concentration of voclosporin and, based on
preliminary testing, appears to be non-irritating. Lux has filed for a patent
covering LX214 with a priority date in 2007. The primary objective of the
phase 1 study is to evaluate the safety and tolerability of LX214 when applied
topically to the eye of healthy volunteers and patients with
keratoconjunctivitis sicca.

    About Dry Eye Syndrome

    Dry eye syndrome (DES) is a condition that includes a variety of
disorders resulting in loss or breakup of the natural tear film, which
maintains lubrication on the surface of the eye. Without this tear film,
vision is impaired, the ocular surface may be damaged and patients may suffer
severe ocular discomfort. Though the exact causes of DES are unknown, there is
evidence supporting the link between reduced tear production and chronic
inflammation of the ocular surface and lacrimal gland. Symptoms associated
with dry eye syndrome account for up to 40% of all ophthalmologist visits and
affect about 10 million people in North America and Europe. Though there are a
variety of medications that palliate the symptoms of DES, there is still no
cure for this debilitating disease. Currently available medications for DES
leave substantial room for more effective and better-tolerated products.

    
    About Isotechnika
    -----------------
    

    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 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 LUVENIQ(TM) 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 our 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.

    
    Forward-Looking Statements
    --------------------------
    

    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:

For further information: Robert Foster, CEO, Isotechnika Inc., Phone:
(780) 487-1600 (x247), Fax: (780) 484-4105, E-mail: rfoster@isotechnika.com;
Stephanie Gillis-Paulgaard, Director, Communications, Isotechnika Inc., Phone:
(780) 909-4661, Fax: (780) 484-4105, E-mail:
sgillis-paulgaard@isotechnika.com

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ISOTECHNIKA PHARMA INC.

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