Isotechnika's Strategic Partner to Highlight Both Topical and Polymer Delivery Technologies Utilizing Voclosporin
EDMONTON, April 28, 2008 /CNW/ - (TSX:ISA) - Isotechnika
Inc. announced today that collaborators with Lux Biosciences,
Inc. are scheduled to present data on the use of voclosporin
with Lux's proprietary topical and new bioerodible
polymer/drug products for the treatment of dry eye and other
inflammatory eye diseases. These multiple presentations
(poster and oral) will take place at the Association for
Research in Vision and Ophthalmology (ARVO) conference
scheduled from April 27 - May 1 in Fort Lauderdale,
Florida.
Lux (one of the Company's strategic partners) is a privately
held biotechnology company specialized in the field of
ophthalmic diseases. Their latest products involving next
generation polymer technologies for the controlled delivery
of drugs and tailor-made product concepts for topical
delivery to the eye offer major market opportunities for new and/or
improved treatments for a variety of chronic inflammatory
ocular conditions.
"Some 15 - 20 million people in North America and Europe are
affected by chronic inflammatory diseases of the eye, which
include such conditions as dry eye, keratoconjunctivitis,
blepharitis and uveitis," said Ulrich Grau, Ph.D. Lux's
President and Chief Executive Officer. "The ophthalmic disease
treatment community has a major need for local delivery of
immunosuppressive therapy that is efficacious, well-tolerated
and suitable for long-term
use."
Lux licensed Isotechnika's next generation calcineurin
inhibitor, voclosporin, for ophthalmic indications - the oral
form of voclosporin (LX211) is currently in phase 3 clinical
development in uveitis. By combining this molecule with
innovative delivery technologies, such as mixed micelles or
bioerodible polymers, Lux believes they can deliver therapeutic
concentrations of drug directly to the eye in a targeted and
sustained fashion, offering the potential to greatly improve
treatment for these widespread ocular
conditions.
Prof. Ashim Mitra and colleagues from the University of Missouri -
Kansas City will present a poster on the development of a
clear, mixed micellar formulation product using voclosporin
(LX214) for the treatment of dry eye syndrome and potentially
other relevant ocular diseases. Of note, the preparation is a
clear fluid and contains a relatively high concentration
(0.2%) of voclosporin. The researchers investigated different
agents to tailor the formulation viscosity, thereby
increasing the drug residence time in the eye. LX214
formulations were well tolerated and did not produce irritation
in animal eyes, as opposed to the comparator 0.05% CsA
emulsion (Restasis(R)). LX214 was also efficacious in a
preliminary study in a dog model of keratoconjunctivitis
sicca (KCS). LX214 is currently in late stages of preclinical
development and is expected to reach the clinic during
2008.
Prof. Joachim Kohn and colleagues from the New Jersey Center
for Biomaterials of Rutgers, The State University of New
Jersey will present orally on the development of a
bioerodible insert for ocular delivery of voclosporin
(LX212). The inserts under investigation were created from
bioerodible polymers selected from a large combinatorial library
developed at Rutgers University and licensed to Lux for
ophthalmic use. When formulated with drug, inserts employing
these polymers exhibit a new hybrid mechanism of drug release
that is capable of sustained drug delivery from 6 to 24
months. As such, these drug/polymer combinations have
potential clinical implications for the treatment of a
variety of immune-mediated ophthalmic conditions. Of note,
the insert will provide sustained, near-constant levels for its
entire lifetime, which has the potential to translate into
improved efficacy when compared to discontinuous dosage
forms, such as oral capsules or drops. The prototype implants
are very small, owing to the fact that the active ingredient
is very potent.
"We believe that our two product concepts for chronic inflammatory
ocular surface diseases have enormous potential given the
very large numbers of patients involved," said Dr. Grau.
"Moreover, with these two product concepts we are in a
position to segment this market and provide tailored products
that specifically address the needs of different patient
populations. Furthermore, Lux Biosciences is employing the
polymer technologies in the development of further products
for our own internal pipeline, and we are also in partnering
discussions for applications outside our own field of
interest."
Interested parties will be able to access the poster by
visiting Isotechnika's corporate website at http://www.isotechnika
.com and accessing the presentations folder in the "For
Investors" section.
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 exceeds $2
billion annually in sales for calcineurin inhibitors such as
voclosporin. 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 LX211 by Lux) for the treatment of uveitis.
Isotechnika Inc. is a publicly traded
company on the Toronto Stock Exchange under the symbol "ISA".
More information on Isotechnika can be found at http://www.isotechnika.com">www.isotechnika.com.
<< Partnerships with Isotechnika Inc. ----------------------------------
- Roche retains an option to continue development of the transplant indications for voclosporin based on the successful completion of the ongoing Phase 2b kidney transplant trial. - Atrium Medical Corporation has exclusive worldwide licensing agreement for use of voclosporin and TAFA93 with drug eluting devices for non-systemic treatment of vascular, cardiovascular, target vessel and tissue disorders. - Lux Biosciences Inc. was granted worldwide rights to develop and commercialize voclosporin for the treatment and prophylaxis of all ophthalmic diseases. >>
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
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funds and resources to pursue research and development
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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: Stephanie Gillis-Paulgaard, Director, Corporate Communications, Isotechnika Inc., Phone: (780) 487-1600 ext 243, Fax: (780) 484-4105, E-mail: sgillis-paulgaard@isotechnika.com">sgillis-paulgaard@isotechnika.com/
Posted: April 2008
