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Isotechnika Inc.

Isotechnika Achieves Full Enrolment for ISA247 Phase 2b Kidney Transplant Trial

Edmonton, Canada (ots/PRNewswire)

Isotechnika Inc. (TSX:ISA)
announced today the enrolment of the last patient in its Phase 2b
trial assessing ISA247 for the prevention of kidney graft rejection
following transplantation. Of the 332 patients enrolled, 148 patients
have already completed the required six months of treatment. The
Company expects to have the last patient complete the six months of
active treatment before the end of the year. Furthermore, 43 patients
have so far completed an additional 6 months of treatment in the
optional extension phase of this trial. As previously announced,
Health Canada granted a No Objection Letter allowing patients who
have already completed 12 months of ISA247 treatment to continue
therapy through to commercialization of the drug.
"We are very excited to have achieved this significant milestone
of completing enrolment and eagerly await the final results of this
trial. Upon receipt of these results, the Company expects to submit
applications to conduct the pivotal Phase 3 trials that are required
for market approval," commented Dr. Randall Yatscoff, Isotechnika's
President & CEO. "Based on the improved safety and efficacy profile
demonstrated to date we are very optimistic about the prospects of
ISA247 as a leading treatment for kidney transplant patients. The
only two existing drugs in the class of calcineurin inhibitors share
a market size of approximately $2.2 billion annually. We are
therefore encouraged not only by the clinical prospects but also by
the market potential of ISA247 as the only late-stage calcineurin
inhibitor currently under development. "
North American Phase 2b Kidney Transplant Trial Design
Forty-two centers across North America have been contracted to
perform the trial, including thirty-eight centers in the United
States and four centers in Canada. The primary endpoint of the trial
is defined as non-inferiority in biopsy proven acute rejection (BPAR)
episodes in patients receiving ISA247 for six months as compared to
the tacrolimus control which  is currently the leading North American
transplant drug in this class. Additionally, kidney function and
other laboratory parameters will be monitored for the duration of the
trial. The overall goal of the trial is to find the most appropriate
dose that will result in efficacy (lack of acute rejection) with
minimal side effects. The use of the other two calcineurin
inhibitors, cyclosporin and tacrolimus, are often associated with
significant safety concerns.
A total of 332 de novo (newly transplanted) kidney transplant
patients have been enrolled in this trial. Patients will be placed
into one of four separate treatment groups; three different dose
groups of ISA247 (0.4 mg/kg, 0.6 mg/kg, and 0.8 mg/kg twice daily
compared with the fourth group, a tacrolimus control arm (0.05 mg/kg
twice daily). Patients in all four treatment groups will have their
doses adjusted in order to achieve pre-defined blood levels of either
ISA247 or tacrolimus. All patients will receive oral dosing with the
drug (ISA247 or tacrolimus) over a six month period along with other
standard immunosuppressive therapies used following transplantation
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 while offering
therapeutic choices to clinicians. Isotechnika looks to become the
market leader of drug therapies for indications such as
transplantation of solid organs (with Hoffman La Roche) and treatment
of autoimmune disorders such as uveitis (with Lux Biosciences) and
psoriasis.
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 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 Phase 3
European/Canadian psoriasis trial and a Phase 2b North American trial
for the prevention of kidney graft rejection subsequent to
transplantation.
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 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 from mild to moderate
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 ISA247 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 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.

Contact:

For further information: Dr. Randall Yatscoff, President & CEO,
Isotechnika Inc., +1-(780)-487-1600 ext 247, +1-(780)-484-4105 (fax),
ryatscoff@isotechnika.com; Stephanie Gillis-Paulgaard, Director,
Corporate Communications, Isotechnika Inc., +1-(780)-909-4661,
+1-(780)-484-4105 (fax), sgillis-paulgaard@isotechnika.com/

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