Tous Actualités
Suivre
Abonner Isotechnika Inc.

Isotechnika Inc.

Isotechnika Announces Preliminary 48 Week Clinical Data From the Phase III ISA247 Psoriasis Trial

Edmonton, Canada (ots/PRNewswire)

Isotechnika Inc. (TSX:ISA)
announced today preliminary 48 week clinical data obtained from its
Phase III psoriasis and extension trials 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 therapy. Those patients who chose to enroll
in the extension trial were moved from the 0.2 mg/kg bid (low dose)
or 0.4 mg/kg bid (high dose) groups into the 0.3 mg/kg bid (mid dose)
group. Patients who commenced the SPIRIT trial in the 0.3 mg/kg bid
dose group remained on the same dosage regimen for the duration of
the extension trial. The goal of the extension trial is to
demonstrate continued therapeutic benefit to psoriasis patients while
gathering long term safety data.
To date, data has been received on 193 patients receiving
treatment for a total of 48 weeks. Patients previously in the low
dose group experienced an improvement in mean percent decrease in
PASI scores from baseline of 41% to 64% after an additional 24 weeks
on the mid dose. Patients previously in the mid and high dose group
remained stable with mean percent decrease from baseline PASI scores
of 61% and 66%, respectively after a total of 48 weeks of treatment.
Of the total patient population, 4.4% (9 patients in the SPIRIT
trial and 11 patients in the extension trial), showed a clinically
significant change in kidney function. There have been no clinically
significant changes noted during the extension trial in any of the
other safety parameters monitored including cholesterol,
triglycerides, new onset diabetes and infectious complications.
"It is essential that new psoriasis medications are developed and
heartening to see that such an efficacious medication with an
excellent 48 week safety profile is in the pipeline," commented Dr.
Robert Auerbach, Clinical Professor of Dermatology, New York
University School of Medicine.
"We are pleased that the extension data shows continued efficacy
and safety of ISA247. The number of patients experiencing a
clinically significant reduction in kidney function is significantly
less than with other calcineurin inhibitors such as cyclosporine
where the incidence is at least 20%," added Dr. Randall Yatscoff,
Isotechnika's President & CEO. "In addition, the absence of any
clinically significant changes in lipids, glucose and blood pressure
levels, along with the absence of significant infectious
complications, supports the long term safety of ISA247
administration."
Management will host a web cast to provide an overview of the
preliminary 48 week clinical data this morning at 9:00 a.m. EST/ 7:00
a.m. MST. All Interested parties can access the live web cast (listen
only mode) by accessing
http://www.newswire.ca/en/webcast/index.cgi?okey=64134 or through the
home page of the Company's corporate Web site at www.isotechnika.com.
The web cast will be archived for 90 days at www.newswire.ca and the
Company's Web site.
About Isotechnika
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 an extension protocol of 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 an additional
immunosuppressive compound in its drug pipeline, TAFA93 which is in
Phase I.
In addition to the Company's drug pipeline, Isotechnika also has a
diagnostic division, which includes the Helikit(R) breath kit. The
Helikit(R), a 13C urea breath test, is used for the detection of H.
pylori, a bacterium that infects a large portion of the population.
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
Isotechnika Inc. has a collaboration agreement with Hoffman La
Roche which licensed the worldwide rights to develop and
commercialize Isotechnika's novel molecule ISA247 for all transplant
indications. In addition, the Company has an exclusive worldwide
licensing agreement with Atrium Medical Corporation for the use of
ISA247 and TAFA93 specifically with drug eluting devices for the
non-systemic treatment of vascular, cardiovascular, target vessel and
tissue disorders.
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 & CEO, Isotechnika Inc., Tel:
+1-780-487-1600 ext 246, +1-780-484-4105 (fax),
ryatscoff@isotechnika.com; Stephanie Gillis-Paulgaard, Director,
Corporate Communications, Isotechnika Inc., Tel: +1-780-909-4661,
+1-780-484-4105 (fax),
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. To request a free copy of this organization's annual
report, please go
to http://www.newswire.ca and click on Tools for Investors.

Plus de actualités: Isotechnika Inc.
Plus de actualités: Isotechnika Inc.
  • 17.03.2006 – 20:04

    Advisory - Isotechnika to Announce Clinical Data From Phase III Psoriasis Trial

    Edmonton, Canada (ots/PRNewswire) - Isotechnika Inc. will announce preliminary 48 week clinical trial data for the Company's Canadian Phase III psoriasis trial for its lead immunosuppressive drug, ISA247, on Monday, March 20th at 8:00 a.m. EST/6:00 a.m. MST. Management will provide an overview of the preliminary 48 week Phase III data following the release ...

  • 05.01.2006 – 15:04

    Isotechnika Enrols First Patient in Phase IIb Kidney Transplant Trial

    Edmonton, Canada (ots/PRNewswire) - Isotechnika Inc. announced today that the Company enrolled its first patient in a North American Phase IIb kidney transplant trial for its lead immunosuppressive drug, ISA247, on January 4, 2006. The trial will be performed at thirty-four centers across North America , including twenty-nine centers in the United States and ...

  • 08.12.2005 – 15:33

    Isotechnika Announces Nine Month Safety Data From the Phase III Psoriasis Trial for ISA247

    Edmonton, Canada (ots/PRNewswire) - Isotechnika Inc. (TSX:ISA) announced today nine month interim safety and efficacy data obtained from its 24 week Phase III psoriasis trial and 12 week extension 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 ...