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Positive Data From Trans-ISA247 Single Ascending Dose Trial
EDMONTON, Canada, July 6 (ots/PRNewswire) -
Isotechnika Inc. (TSX:ISA) announced today the completion of the
single ascending dose trial for the Company's lead immunosuppressive
drug candidate, ISA247. The SAD trial was conducted in healthy
volunteers using the trans-ISA247 formulation to assess the
appropriate dosage of the enhanced composition of the drug.
The data confirms that the trans formulation of ISA247 is
approximately 1.5 times more potent than the original mixture and up
to 5 times more potent than cyclosporine. Additionally, the results
demonstrate an even stronger correlation between blood drug
concentration and the observed immunosuppressive effect confirming
the reduction in inter-patient and intra-patient variability. This
finding is significant, as there is a very poor correlation between
patient's blood concentrations of drugs such as cyclosporine and the
observed immunosuppressive effect. Hence, therapeutic drug monitoring
(TDM) of ISA247 will allow for optimisation of clinical response
while minimising the potential for adverse drug events.
Our original formulation of ISA247 (consisting of two geometric
isomers: cis and trans) was less nephrotoxic than cyclosporine.
Results of the current SAD trial indicate that drug effects of
trans-ISA247 on the kidney have been reduced even further than the
original formulation suggesting that trans-ISA247 offers significant
advantages over currently used calcineurin inhibitors such as
"The SAD trial met all primary and secondary endpoints with no
serious adverse events," stated Dr. Randall Yatscoff, Isotechnika's
President and COO. "The results with trans-ISA247 far exceeded our
expectations. The therapeutic window with this formulation appears to
be wider than that previously observed with the original formulation.
These results validate our decision to move forward with the trans
formulation of ISA247 and facilitate Isotechnika meeting its drug
development timelines for this year."
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 commercialise 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.
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 use in
the prevention of organ rejection in transplantation and in the
treatment of autoimmune diseases. Isotechnika looks to become the
leader in development of immunosuppressant therapies.
Isotechnika's lead drug, ISA247, presently referred to as
trans-ISA247, is an immunosuppressant that has successfully completed
a Phase II trial for psoriasis and Phase IIa trial for kidney
transplantation. Isotechnika recently expanded its product pipeline
by developing two additional novel immunosuppressive compounds,
TAFA-93 and TKB662. TAFA-93 is a novel small molecule mTOR inhibitor,
a class of drugs currently used in the prevention of organ rejection
in transplantation and as a coated stent therapy in the treatment of
coronary artery disease. Pre- clinical studies of TKB662 have
demonstrated inhibition of T cell and B cell activation and
proliferation through multiple mechanisms of action including the
inhibition of lymphocyte phosphorylation activity. As both TAFA-93
and TKB662 have distinct mechanisms of action from calcineurin
inhibitors such as ISA247 they have the potential to be administered
as complementary therapies in both prevention of organ rejection and
treatment of autoimmune diseases. Isotechnika Inc. is an S&P/TSX
Composite Index company publicly traded under the symbol ISA. More
information on Isotechnika can be found at www.isotechnika.com.
ots Originaltext: Isotechnika Inc.
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