Alle Storys
Folgen
Keine Story von Isotechnika Inc. mehr verpassen.

Isotechnika Inc.

Isotechnika Inc. Achieves all Endpoints in Multiple Ascending Dose Study for ISA247

Edmonton, Canada, November 3 (ots/PRNewswire)

Isotechnika Inc.
announced today that the Company has successfully completed the
multiple ascending dose study for its lead immunosuppressive drug,
ISA247.
The multiple ascending dose (MAD) study for ISA247 that commenced
on June 3, 2004 involved a total of 43 subjects. The study, conducted
by SFBC Anapharm in Montreal, Quebec achieved all safety endpoints.
Healthy volunteers were administered ISA247 with the first dose being
0.25 mg/kg given orally twice daily for a total of 10 days. On
subsequent occasions, separate groups of volunteers were administered
dosages of either 0.5, 1.0, or 1.5mg/kg given twice daily for a total
of 10 days. At anticipated therapeutic doses for psoriasis treatment,
subjects experienced no clinically significant impact on renal
function as measured either by serum creatinine or 24-hour creatinine
clearance determinations. Final dosing recommendations, however, will
be determined in a planned upcoming Phase III clinical trial in
psoriasis patients. Other currently marketed medications belonging to
the same therapeutic class of drugs (i.e. calcineurin inhibitors)
exhibit clinically significant deleterious effects on kidney function
at therapeutic doses. The absence of these renal effects with ISA247,
therefore, is significant. Furthermore, no serious adverse events
were observed for any other body system examined in the study.
In addition to the completion of the MAD study, two additional
studies were successfully finished; a food effect and a
bioequivalence study.
"We fully expected that these last few trials would be completed
successfully. The results obtained reconfirm our decision to move
forward with the more therapeutically active trans-ISA247. The
trans-ISA247 formulation is a more potent immunosuppressant, has
better predictability between dosing and resultant blood
concentrations, and allows dosing at therapeutic blood concentrations
of drug without significant side-effects so commonly encountered with
this class of important drugs," stated Dr. Randall Yatscoff,
Isotechnika's President & COO. "We are well poised to enter a Phase
III clinical trial for psoriasis treatment later this year."
The management team will provide a scientific update to the
investment community this morning commencing at 9:00 a.m. EST/ 7:00
a.m. MST. All Interested parties can access the live web cast (listen
only mode) by entering
http://www.newswire.ca/en/webcast/viewEvent.cgi?eventID(equal
sign)955240 in their web browser. Alternatively, you may access the
web cast through our corporate Web site at www.isotechnika.com. The
web cast will be archived for a 90 day period through the web cast
archives at www.newswire.ca.
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,
TAFA93 and TKB662. TAFA93 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 TAFA93 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.
In addition to the Company's drug pipeline, Isotechnika also has a
diagnostic division, which includes the Helikit(TM) and Diatest(TM)
breath kits. The Helikit(TM), a 13C breath test is used for the
detection of H.pylori, a bacterium that infects a large portion of
the population. The Helikit(TM) is currently sold internationally.
The Diatest(TM), a 13C glucose breath test is used for the detection
of insulin resistance. The Company expects to commence the necessary
clinical trials in 2005 involving the Diatest(TM) to obtain
regulatory approval in the United States. 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.
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.

Contact:

Dr. Randall Yatscoff, President & COO, Isotechnika Inc., tel:
+1-(780)-487-1600 Ext.246, Fax: +1-(780)-484-4105, Email:
ryatscoff@isotechnika.com; Stephanie Gillis-Paulgaard, Manager,
Corporate Communications, Isotechnika Inc., tel +1-(780)-487-1600
Ext. 243, Fax: +1-(780)-484-4105,
E-mail:sgillis-paulgaard@isotechnika.com; Archived images on this
organisation are available through CNW E-Pix at
http://www.newswire.ca. Images are free to members of The Canadian
Press. To request a free copy of this organisation's annual report,
please go to http://www.newswire.ca and click on reports@cnw

Weitere Storys: Isotechnika Inc.
Weitere Storys: Isotechnika Inc.
  • 09.09.2004 – 14:06

    Isotechnika Inc. Reports Interim Results of QTc Trial

    Edmonton, Alberta, Canada (ots/PRNewswire) - Isotechnika Inc. announced today they have received the interim results of the QTc trial for its lead immunosuppressive drug, ISA247 from eResearch Technology Inc. The study, conducted by Pracs in Fargo, North Dakota was designed as a double blind, parallel group, placebo and moxifloxacin controlled, randomized, single dose QTc study of trans-ISA247 in healthy volunteers. In ...

  • 07.07.2004 – 14:03

    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 ...