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Isotechnika Inc.

Isotechnika Announces Initial Data From Phase IIb Kidney Transplant Trial

Edmonton, Canada, November 16 (ots/PRNewswire)

- Transplant Data Presented at the American Society of Nephrology
Conference
Isotechnika Inc. today announced results from initial data for its
Phase IIb kidney transplant trial of the Company's lead
immunosuppressive drug, ISA247.
To date, 133 patients have been enrolled in the trial. Based on an
early review of the unaudited data, the Company has observed a
similar incidence of rejection episodes between the low (0.4 mg/kg
twice daily) and mid (0.6 mg/kg twice daily) ISA247 dosing groups as
in the tacrolimus control arm. To date, there have been no rejections
in the high (0.8 mg/kg twice daily) ISA247 dose group. When all three
of the ISA247 dosing groups are combined, there is an 8% rate of
acute rejection in the ISA247 groups compared to a 14% rate in the
tacrolimus group, which is being dosed according to clinical
practice.
As part of the trial, kidney function is being measured by
Glomerular Filtration Rate (GFR) on an ongoing basis. Based on the
data generated to date, very good kidney function has been observed
in all of the ISA247 dosing groups. Within the first month
post-transplant, kidney function showed improvement across all ISA247
dosing groups similar to that observed in the tacrolimus group.
Additionally, there have been no clinically significant differences
noted in cholesterol and triglycerides or other laboratory parameters
examined to date in patients receiving ISA247.
"We are pleased that all three ISA247 doses are showing good
efficacy while maintaining very good kidney function," stated Dr.
Randall Yatscoff, President & CEO of Isotechnika. "Furthermore,
ISA247 continues to demonstrate a strong Pharmacokinetics and
Pharmacodynamics (PK/PD) correlation which should facilitate ease of
dosing to achieve desired targeted drug concentrations in blood."
The Phase IIb kidney transplant data is being presented today at
the American Society of Nephrology Conference in San Diego. The
poster entitled "ISA247: A Novel Calcineurin Inhibitor (CNI) A
Promising Safety Profile With Enhanced Efficacy" will be presented by
Dr. Robert Gaston, one of the principal investigators involved in the
Phase IIb trial. All interested parties will be able to access a copy
of the scientific poster in the Investor Relations section of the web
site.
The management team will provide an update on the current status
of the Phase IIb kidney transplant trial via a live web cast this
morning at 9:00 a.m. ET/7:00 a.m. MT. All interested parties will be
able to access the live event through the Company's corporate web
site at www.isotechnika.com.
Trial Design
Forty-two centres across North America have been contracted to
perform the trial, including thirty-seven centres in the United
States and five centres in Canada. The primary endpoint of the trial
is defined as non-inferiority in biopsy proven acute rejection (BPAR)
episodes in patients receiving ISA247 for six months as compared to
the tacrolimus control which is currently the North American leading
transplant drug in this class. Additionally, kidney function and
other laboratory parameters will be monitored for the duration of the
trial. The overall goal of the trial is to find the most appropriate
dose that will result in efficacy (lack of acute rejection) with
minimal side effects that are typically seen with other calcineurin
inhibitors such as cyclosporine and tacrolimus.
A total of 332 de novo (newly transplanted) kidney transplant
patients will be enrolled in this trial. Patients will be placed into
one of four separate treatment groups; three different dose groups of
ISA247 (0.4 mg/kg, 0.6 mg/kg, and 0.8 mg/kg twice daily) compared
with the fourth group, a tacrolimus (0.05 mg/kg twice daily) control
arm. Patients in all four treatment groups will have their doses
adjusted in order to achieve pre-defined blood levels of either
ISA247 or tacrolimus. All patients will receive oral treatment of
drug (ISA247 or tacrolimus) over a six month period along with other
standard immunosuppressive therapies used following transplantation.
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 has successfully completed a
Canadian Phase III human clinical trial for the treatment of moderate
to severe psoriasis. ISA247 is currently being investigated in a
North American Phase IIb human clinical trial for the prevention of
kidney graft rejection. The Company also has an additional
immunosuppressive compound in its drug pipeline, TAFA93 which
successfully completed Phase I clinical trials.
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. signed a collaboration agreement with Hoffman La
Roche on April 9, 2002, which licensed the worldwide rights to
develop and commercialise ISA247 for all transplant indications.
On September 30, 2005, Isotechnika Inc. entered into 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.
Isotechnika Inc. and Cellgate Inc. signed an option agreement on
April 25, 2006, granting Isotechnika the option to obtain an
exclusive license to develop and commercialise conjugates consisting
of Cellgate's patented transporter technology for the topical
delivery of ISA247 in patients suffering from mild to moderate
psoriasis.
On May 25, 2006, Isotechnika Inc. signed an agreement with Lux
Biosciences, Inc. of Jersey City, New Jersey granting Lux Biosciences
worldwide rights to develop and commercialise Isotechnika's lead
drug, 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 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.

Contact:

For further information: Dr. Randall Yatscoff, President & CEO,
Isotechnika Inc., Phone: +1-780-487-1600 Ext. 246, Fax:
+1-780-484-4105, Email: ryatscoff@isotechnika.com; Stephanie
Gillis-Paulgaard, Director, Corporate Communications, Isotechnika
Inc., Phone: +1-780-909-4661, Fax: +1-780-484-4105, E-mail:
sgillis-paulgaard@isotechnika.com

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