Edmonton, Canada (ots/PRNewswire) -
- Trades on Toronto Stock Exchange - (TSX:ISA)
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
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 at www.isotechnika.com.
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 disorders.
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
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.
ots Originaltext: Isotechnika Inc.
Im Internet recherchierbar: http://www.presseportal.ch
For further information: Dr. Randall Yatscoff, President & CEO,
Isotechnika Inc., Phone: +1-780-487-1600 Ext. 247, Fax:
+1-780-484-4105, Email: email@example.com; Stephanie
Gillis-Paulgaard, Director, Corporate Communications, Isotechnika
Inc., Phone: +1-780-487-1600 Ext. 243, Fax: +1-780-484-4105, E-mail: