Trades on Toronto Stock Exchange - (TSX:ISA)
EDMONTON, June 6 /CNW/ - Isotechnika Inc. announced today that the
Company received approval from the Polish Competent Authority for
participation in the ongoing Phase 3 European/Canadian clinical trial. This
trial investigates the use of ISA247 in patients suffering from moderate to
severe psoriasis. The Company previously received approval from the German
Competent Authority and Health Canada to commence the trial. At present, a
total of 283 patients have been enrolled in Germany and Canada.
"The addition of twelve clinical trial sites in Poland allows others to
gain experience with ISA247 for the treatment of psoriasis and further
broadens our investigator base. Addition of these sites, to the twenty-nine
sites already established in Germany and Canada, should facilitate us meeting
our expected recruitment timelines for this trial," stated Dr. Randall
Yatscoff, Isotechnika's President & CEO. "Patient enrolment in Poland is
expected to commence immediately."
Phase 3 European/Canadian Trial Design
The Phase 3 European/Canadian psoriasis trial (ESSENCE) will be performed
at forty-one clinical centers in Canada, Germany, and Poland. The 24-week
trial is being conducted as a randomized, orally administered placebo and
cyclosporine controlled trial. To maximize the benefit to patients enrolled in
the placebo group, all patients randomized to the placebo group will receive
active treatment with ISA247 beginning after 12 weeks of placebo dosing.
To determine successful completion of the trial, the following efficacy
parameters will be measured: Static Physician's Global Assessment (SPGA)
scores, Psoriasis Area and Severity Index (PASI) scores. Safety parameters
will also be monitored by measuring the prevalence of adverse events,
including altered kidney function.
About Isotechnika Inc.
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 while offering therapeutic choices to clinicians.
Isotechnika looks to become the market leader of drug therapies for
indications such as transplantation of solid organs and treatment of
autoimmune disorders such as psoriasis.
There is a significant unmet medical need in both solid organ
transplantation and autoimmune disease. It is estimated that the market
potential far exceeds $1 billion annually in sales for calcineurin inhibitors
such as ISA247.
Isotechnika's lead drug, ISA247, has successfully completed a Phase 3
Canadian trial for the treatment of moderate to severe psoriasis. ISA247 is
currently being investigated in a combined Phase 3 European/Canadian psoriasis
trial and a Phase 2b North American trial for the prevention of kidney graft
rejection. One of our partners, Lux Biosciences, has received permission from
the regulatory bodies in Austria, Canada, France, Germany, India, the United
Kingdom and the United States to investigate ISA247 in three separate pivotal
Phase 2/Phase 3 trials for the treatment of non-infectious uveitis and as a
maintenance therapy in uveitis.
Isotechnika Inc. is a publicly traded company on the Toronto Stock
Exchange under the symbol "ISA". More information on Isotechnika can be found
Partnerships with Isotechnika Inc.
Isotechnika Inc. signed a collaboration agreement with Hoffman La Roche
on April 9, 2002, which licensed the worldwide rights to develop and
commercialize ISA247 for all transplant indications.
On September 30, 2005, Isotechnika Inc. entered into an exclusive
worldwide licensing agreement with Atrium Medical Corporation for the use of
ISA247 and TAFA93 specifically with drug eluting medical devices for the
non-systemic treatment of vascular, cardiovascular, target vessel and tissue
Isotechnika Inc. and Cellgate Inc. signed an option agreement on
April 25, 2006, granting Isotechnika the option to obtain an exclusive license
to develop and commercialize conjugates consisting of Cellgate's patented
transporter technology for the topical delivery of ISA247 in patients
suffering all forms of psoriasis.
On May 25, 2006, Isotechnika Inc. signed an agreement with Lux
Biosciences, Inc. of Jersey City, New Jersey granting Lux Biosciences
worldwide rights to develop and commercialize Isotechnika's lead drug, ISA247,
for the treatment and prophylaxis of all ophthalmic diseases.
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: Dr. Randall Yatscoff, President & CEO,
Isotechnika Inc., Phone: (780) 487-1600 Ext. 247, Fax: (780) 484-4105, Email:
email@example.com; Stephanie Gillis-Paulgaard, Director, Corporate
Communications, Isotechnika Inc., Phone: (780) 487-1600 Ext. 243, Fax: (780)
484-4105, E-mail: firstname.lastname@example.org