Isotechnika Inc. completes critical study
EDMONTON, Nov. 22 /CNW/ - Isotechnika Inc. announced today the
results
from the rat carcinogenicity study for its lead immunosuppressive
drug,
ISA247. ISA247 did not exhibit any carcinogenicity up to the
highest doses
tested in male and female rats over a two year period.
Carcinogenicity studies are required by
the United States Food and Drug
Administration (FDA) and other Regulatory Authorities and are a
critical part
of the package submitted for marketing approval. Carcinogenicity
studies are
performed by administering a range of doses of a drug, including a
dose
considerably higher than the anticipated clinical dose for a period
of two
years. This timeframe is equivalent to administering the drug over
a lifetime
in humans.
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. 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.
ISA247 is currently being investigated in
a Phase 2b North American trial
for the prevention of kidney graft rejection subsequent to
transplantation and
a Phase 3 European/Canadian psoriasis trial.
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.
----------------------------------
<<
- Roche retains an option to
continue development of the transplant
indications based on the
successful completion of the ongoing Phase 2b
kidney transplant
trial.
- Atrium Medical Corporation has
exclusive worldwide licensing agreement
for use of ISA247 and
TAFA93 with drug eluting devices for non-
systemic treatment of
vascular, cardiovascular, target vessel and
tissue disorders.
- Lux Biosciences Inc. was
granted 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.
%SEDAR: 00010508E
-30-
/For further information: Dr. Robert Foster, Chairman & CEO,
Isotechnika
Inc., Phone: (780) 487-1600 (x247), Fax: (780) 484-4105,
E-mail:
rfoster@isotechnika.com;
Stephanie Gillis-Paulgaard, Director, Corporate
Communications, Isotechnika Inc., Phone: (780) 487-1600 (x243),
Fax: (780)
484-4105, E-mail: sgillis-paulgaard@isotechnika.com/
Posted: November 2007
