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Isotechnika Inc.

Isotechnika's Phase III Psoriasis Trial Achieves Clinical Endpoints

Edmonton, Canada (ots/PRNewswire)

Isotechnika Inc. announced
today the unblinded 12 week data for the Company's Canadian Phase III
psoriasis trial for its lead immunosuppressive drug, ISA247.
    A Summary of the results is as follows:
    - The study met all primary and secondary efficacy endpoints determined
      at 12 weeks
    - Efficacy endpoints were achieved with minimal side effects
    - No clinically significant differences in mean serum creatinine and
      glomerular filtration rate (GFR) were observed amongst the four
      treatment groups at 12 weeks
The Canadian Phase III Psoriasis (SPIRIT) trial commenced on
December 2, 2004 and included a total of 453 patients with stable
moderate to severe plaque psoriasis. The trial was conducted at 32
sites over a 24 week period using orally administered ISA247 in
psoriatic patients. This randomized, double-blind trial examined the
efficacy of three dosing groups of ISA247 (0.2 mg/kg, 0.3 mg/kg and
0.4 mg/kg) administered twice daily compared to placebo with equal
numbers of patients assigned to each of the four treatment groups.
"Our goal was to create a drug with a superior safety and efficacy
profile compared to other medications used to treat psoriasis,"
stated Dr. Randall Yatscoff, Isotechnika's President and COO. "We are
pleased to have achieved these goals in the interim data analysis
which indicates the presence of a therapeutic window. It is very
encouraging to see that our 24 week endpoints were achieved at the 12
week point of the trial."
In the high dose group, 48% of the patients achieved a PASI 75
score and 72% achieved a PASI 50 score. Furthermore, in the mid dose
group 24% and 47% of the patients achieved PASI 75 and PASI 50
scores, respectively. Both the PASI 50 and PASI 75 scores were
clinically significant (p less than 0.05) versus placebo. The mean
percentage reduction in the PASI scores of the high dose group and
the mid dose group were 62.5% and 44.0%, respectively.
Incidences of treatment-related adverse events in patients
receiving ISA247 were similar to those receiving placebo.
Additionally, there were no clinically significant changes noted in
any of the parameters monitored including hypertension, cholesterol,
triglycerides and infectious complications analyzed for the interim
report. The highest mean change in serum creatinine at 12 weeks was
5% above baseline in the high dose (0.4 mg/kg twice daily) group.
This mean percentage change is not clinically significant as it is
within normal analytical and physiological variation. After 12 weeks
of treatment, a total of five patients, (four in the high dose (4%)
and one in the mid dose (1%)) were withdrawn from the trial due to a
clinically significant effect on kidney function.
"The results with ISA247 indicate that efficacy equals that of the
best treatments presently available for severe psoriasis. This study
positions ISA247 as a possible first line therapy for severe
psoriasis while providing a side-effect profile not different from
placebo," states Dr. Gilles Lauzon, Director of the Division of
Dermatology at the University of Alberta.
The management team will provide an overview of the unblinded
interim Phase III psoriasis data to the investment community this
morning commencing at 9:00 a.m. ET/ 7:00 a.m. MT. All Interested
parties can access the live web cast (listen only mode) by entering
http://www.newswire.ca/en/webcast/index.cgi?okey(equal sign)64134 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 six month 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
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 a Canadian Phase III human clinical trial for the
treatment of moderate to severe psoriasis. In addition, ISA247 has
successfully completed a Phase IIa trial for kidney transplantation.
The Company also has two additional immunosuppressive compounds in
its drug pipeline, TAFA93 and TKB662 which are in Phase I and
pre-clinical respectively.
In addition to the Company's drug pipeline, Isotechnika also has a
diagnostic division, which includes the Helikit(R) and Diatest(R)
breath kits. The Helikit(R) a (13)C urea breath test is used for the
detection of H. pylori, a bacterium that infects a large portion of
the population. The Diatest(R) a (13)C glucose breath test is used to
measure insulin resistance.
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.
To request a free copy of this organization's annual report,
please go to http://www.newswire.ca and click on reports@cnw

Contact:

For further information: Dr. Randall Yatscoff, President & COO,
Isotechnika Inc., Phone: +1-(780)-487-1600 Ext. 246, Fax:
+1-(780)-484-4105, Email: ryatscoff@isotechnika.com; Stephanie
Gillis-Paulgaard, Senior Manager, Corporate Communications,
Isotechnika Inc., Phone: +1-(780)-487-1600 Ext. 243, Fax:
+1-(780)-484-4105, E-mail:sgillis-paulgaard@isotechnika.com; Archived
images on this organization are searchable through CNW Photo Archive
website at http://photos.newswire.ca. Images are free to accredited
members of the media.

Plus de actualités: Isotechnika Inc.
Plus de actualités: Isotechnika Inc.
  • 14.09.2005 – 15:01

    Isotechnika Announces Ninety Per Cent Participation in Phase III Psoriasis Extension Trial

    Edmonton, Canada (ots/PRNewswire) - Isotechnika Inc. (TSX: ISA) announced today the participation level in its Canadian Phase III psoriasis extension trial for its lead immunosuppressive drug, ISA247. Patients completing the 24 week Canadian Phase III SPIRIT trial were given the opportunity to continue therapy for an additional 36 weeks or to discontinue ...

  • 03.08.2005 – 13:03

    Isotechnika Announces Interim Blinded Phase III Psoriasis Results

    Edmonton, Canada (ots/PRNewswire) - Isotechnika Inc. (TSX: ISA) announced today that the Canadian Phase III psoriasis trial for its lead immunosuppressive drug, ISA247, continues to demonstrate a promising safety and efficacy profile. The Canadian Phase III Psoriasis (SPIRIT) trial commenced on December 2, 2004 and includes a total of 453 patients with ...

  • 12.05.2005 – 13:31

    Isotechnika Granted Permission From FDA for Phase IIb Kidney Transplant Trial

    Edmonton, Alberta (ots/PRNewswire) - Isotechnika Inc. announced today that the Company has received permission from the Food and Drug Administration of the United States to proceed with a Phase IIb kidney transplant trial for its lead immunosuppressive drug, ISA247. The planned randomized, open-label trial will include approximately 332 de novo (newly ...