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FDA Grants Permission to Isotechnika for TAFA-93 Clinical Trial
EDMONTON, Canada, July 7 (ots/PRNewswire) -
Isotechnika Inc. today announced that the Company has received
permission from the Food and Drug Administration of the United States
for the commencement of a Phase Ib human clinical trial for TAFA-93.
TAFA-93 is a novel prodrug of the mTOR inhibitor rapamycin
designed to reduce the unfavourable pharmacokinetics and side effects
of rapamycin. mTOR inhibitors are currently used in the prevention of
organ rejection in transplantation, in the treatment of auto-immune
and oncological diseases, and as a component of coated stents for the
treatment of coronary artery disease. Due to the distinct mechanism
of action of TAFA-93 from calcineurin inhibitors such as ISA247,
Isotechnika's lead drug, TAFA-93 has the potential to be administered
as a complementary therapy along with ISA247 in the prevention of
organ rejection after transplantation.
A Canadian Phase Ia trial for TAFA-93 is currently ongoing in
Montreal, Quebec. Upon receipt of the preliminary data from the Phase
Ia trial, Isotechnika will commence the US Phase Ib trial. The
Company anticipates the commencement of the Phase Ib trial to take
place this fall. Clinical trial site selection for the phase Ib trial
is currently underway.
"We are extremely pleased with the FDA's decision to allow
Isotechnika to move forward with a Phase Ib trial for TAFA-93,"
stated Dr. Randall Yatscoff, Isotechnika's President and COO. "Our
drug development program continues to meet the timelines set for this
year. With two of our three drug candidates now in the clinical phase
we remain focused on expanding our pipeline in novel
immunosuppressive drug therapies," added Yatscoff.
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 mTOR inhibitors
mTOR inhibitors are a class of immunosuppressive drugs which
includes Rapamune(R), that inhibit T cell activation at a different
stage in the immune response as compared to other classes (i.e.
calcineurin inhibitors, DNA synthesis inhibitors). In
transplantation, mTOR inhibitors are typically used in combination
with calcineurin inhibitors. The side effects (hyperlipidemia,
gastrointestinal effects, thrombocytopenia), of this class of drugs
currently limit its broader use in transplantation and in the
treatment of auto-immune diseases. The current market for this class
of drugs is in excess of 0.5 billion USD per year globally.
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 a publicly
traded company on the Toronto Stock Exchange under the symbol ISA.
More information on Isotechnika can be found at www.isotechnika.com.
ots Originaltext: Isotechnika Inc.
Im Internet recherchierbar: http://www.newsaktuell.ch
Dr. Randall Yatscoff, President and COO, Isotechnika Inc., Phone:
+1-780-487-1600 extension 246, Fax: +1-780-484-4105, E-mail:
firstname.lastname@example.org; Stephanie Gillis-Paulgaard, Manager,
Corporate Communications, Isotechnika Inc., Phone: +1-780-487-1600
extension 243, Fax: +1-780-484-4105, E-mail:
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