• 21.08.2006, 15:05:40
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  • OTE0005

Isotechnika Inc. Announces Promising Results From Phase I TAFA93 Trials

Edmonton, Alberta (ots/PRNewswire) -

- Isotechnika Inc. announced today promising results from its
Phase I TAFA93 trials. TAFA93, a pro-drug of rapamycin, is a novel
small molecule mTOR inhibitor, which is a class of drugs currently
used in the prevention of organ rejection in transplantation. mTOR
inhibitors are typically used in combination with calcineurin
inhibitors after organ transplant. mTOR inhibitors also have
potential use in oncology and in cardiac stent technology.

A TAFA93 Phase Ia single center, randomized, placebo-controlled,
Single Ascending Dose (SAD) trial commenced in July, 2004. The
results indicated that doses of 0.04, 0.08 and 0.16 mg/kg TAFA93
taken once daily were safe and well tolerated in healthy volunteers.
No serious adverse events were reported. The data obtained from the
Phase Ia trial was used to ascertain the most appropriate dose
levels for the Phase Ib clinical trial.

Earlier this year a Phase Ib, single center, randomized, placebo-
controlled, Multiple-Ascending Dose (MAD), double-blind trial was
conducted with TAFA93. The primary objective of this study was to
assess the tolerability, safety and pharmacokinetics of multiple
doses of TAFA93 in healthy volunteers. Thirty six subjects were
randomized to receive either placebo or oral doses of TAFA93 (0.04,
0.08 or 0.16 mg/kg once daily) for 13 consecutive days.

Overall, the Phase Ib TAFA93 trial suggested that the drug was
very well tolerated. No serious adverse events were reported during
the trial. TAFA93 administration in the dose range of 0.04 mg/kg to
0.16 mg/kg resulted in dose-proportional rapamycin pharmacokinetics,
following both single and multiple doses with stable and linear
pharmacokinetics. In addition, the pharmacokinetic profiles display
less peak-to-trough variability due to a modified input of the drug,
when compared to historical rapamycin data.

The successful completion of the Phase I TAFA93 trials fulfills
one of our commitments to Atrium Medical Corporation ("Atrium") and
allows Atrium to continue moving forward with their drug eluting
stent technology program.

"Our theory is that having drug concentrations within a
therapeutic window for a longer period of time may be beneficial
giving immunosuppressive coverage for a more prolonged period of
time," stated Dr. Randall Yatscoff, Isotechnika's President and CEO.
"These results from these trials are consistent with this theory.
This may result in optimized immunosuppressive efficacy and reduced
side effects normally associated with this drug class."

About Isotechnika Inc.

Isotechnika Inc. is an international biopharmaceutical company
headquartered in Edmonton, Alberta, Canada. Drawing upon its
expertise in medicinal chemistry and immunology, the Company is
focused on the discovery and development of novel immunosuppressive
therapeutics that are safer than currently available treatments. Its
entrepreneurial management and world- class team of scientists are
building a pipeline of immunosuppressive drug candidates for
treatment of autoimmune diseases and for use in the prevention of
organ rejection in transplantation. Isotechnika looks to become the
leader in development of immunosuppressant therapies.

Isotechnika's lead compound, ISA247 is an immunosuppressant
currently in an extension protocol of a Canadian Phase III human
clinical trial for the treatment of moderate to severe psoriasis and
a North American Phase IIb human clinical trial for the prevention
of kidney graft rejection. The Company also has an additional
immunosuppressive compound in its drug pipeline, TAFA93 which is in
Phase I.

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.

Isotechnika's Partnership with Atrium Medical Corporation

In September, 2005, Isotechnika signed an exclusive worldwide
licensing agreement for the use of TAFA93 and ISA247 specifically
with drug eluting devices for the non-systemic treatment of
vascular, cardiovascular disorders, target vessel and tissue
disorders.

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.

Rückfragehinweis:
Dr. Randall Yatscoff, President & CEO, Isotechnika Inc.,
+1(780)-487-1600 (246), +1(780)-484-4105 (fax),
[email protected]; Stephanie Gillis-Paulgaard, Director,
Corporate Communications, Isotechnika Inc., +1(780)-909-4661,
+1(780)-484-4105 (fax), [email protected]

OTS-ORIGINALTEXT PRESSEAUSSENDUNG UNTER AUSSCHLIESSLICHER INHALTLICHER VERANTWORTUNG DES AUSSENDERS - WWW.OTS.AT | PRN

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