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Isotechnika Announces Interim Three Month Data From Phase 2b Kidney Transplant Trial

Geschrieben am 07-05-2007

Edmonton, Alberta (ots/PRNewswire) - Isotechnika Inc. today
announced the audited three month results, reviewed by the Data
Monitoring Committee, of the first third of the patients treated in
its Phase 2b de novo kidney transplant trial for the Company's lead
immunosuppressive drug, ISA247.

This interim analysis is based upon the assessment of the first
116 patients enrolled. There have been 28 patients treated with the
low dose (0.4 mg/kg twice daily) resulting in 11% incidence of acute
rejection; 25 patients treated with the mid dose (0.6 mg/kg twice
daily) resulting in 8% incidence of acute rejection; and 29 patients
treated with the high dose (0.8 mg/kg twice daily) resulting in 3%
incidence of acute rejection, as compared to 34 patients treated with
tacrolimus, resulting in 9% incidence of acute rejection. All
rejection episodes were appropriately treated. No transplanted
kidneys have been lost. When all three of the ISA247 dosing groups
are combined, there is a 7% rate of acute rejection in the ISA247
groups compared to a 9% rate of acute rejection in the tacrolimus
group, which is being dosed optimally.

As part of the trial, kidney function is being measured on an
ongoing basis by Glomerular Filtration Rate (GFR). Based on the data
generated to date, very good kidney function has been observed in all
of the ISA247 dosing groups. Within the first month post-transplant,
kidney function showed improvement across all ISA247 dosing groups
similar to that observed in the tacrolimus group. Fewer incidences of
hypomagnesemia, neurological side effects, and new onset diabetes
mellitus have been observed with all ISA247 dosing groups as compared
to tacrolimus. There have been no clinically significant differences
noted in blood pressure, lipids (cholesterol and triglycerides) or
other laboratory parameters examined to date. Additionally, the
strong pharmacokinetic/pharmacodynamic correlation seen with ISA247
remains consistent with previous data reported which should
facilitate ease of dosing to target concentrations and effect.

"The interim three month data continues to support that all three
ISA247 doses are efficacious with very good kidney function in each
dose group," stated Dr. Randall Yatscoff, President & CEO of
Isotechnika. "Most encouraging is the low rate of acute rejection
coupled with an improved safety profile. To date, the Company has
enrolled 277 patients of the 332 patients required for this trial.
We are also encouraged that 100% of the patients have opted to
continue receiving therapy for an additional six months after
completing the first six months of the trial."

The management team will provide a review of the Phase 2b kidney
transplant trial via a live conference call this morning at 9:00 a.m.
ET/7:00 a.m. MT. All interested parties will be able to access the
live event (audio only) through the Company's corporate web site at
www.isotechnika.com.

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 North American leading
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 that are typically seen with other calcineurin
inhibitors such as cyclosporine and tacrolimus.

A total of 332 de novo (newly transplanted) kidney transplant
patients will be 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 (0.05 mg/kg twice daily) control arm.
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 treatment of 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 safer than currently
available treatments. Isotechnika looks to become the leader in
development of immunosuppressant therapies. 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 Food and Drug Administration 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

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 Isotechnika's lead
drug, 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.

ots Originaltext: Isotechnika Inc.
Im Internet recherchierbar: http://www.presseportal.de

Contact:
For further information: Dr. Randall Yatscoff, President & CEO,
Isotechnika Inc., Phone:+1-780-487-1600 Ext. 246,
Fax:+1-780-484-4105, Email: ryatscoff@isotechnika.com; Stephanie
Gillis-Paulgaard, Director, Corporate Communications, Isotechnika
Inc., Phone:+1-780-909-4661, Fax:+1-780-484-4105,
E-mail:sgillis-paulgaard@isotechnika.com


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