- Company Set to Host Evening Symposium at ATC -
EDMONTON, March 27 /CNW/ - Isotechnika Inc. announced today that an
independent data monitoring committee (DMC) has met and reviewed the interim
data from the Phase 2b kidney transplant (PROMISE) trial. The review included
3 month data from approximately 1/3 of the anticipated 332 patients to be
enrolled. The DMC has recommended that the trial continue according to the
original study design. There were no concerns in this review with regards to
the safety or efficacy of ISA247 in this patient population.
"The DMC was formed as a special safeguard to ensure the best interests
of the patients participating in this trial," commented Dr. Yatscoff,
Isotechnika's President & CEO. "Their independent review of the three month
data is consistent with our internal analysis which suggests that ISA247 is
safe and efficacious in this patient population."
Following the independent review by the DMC, Isotechnika is set to host
an evening symposium at the American Transplant Congress this May. Further
details regarding the symposium will be forthcoming.
North American Phase 2b Kidney Transplant Study Design
Forty-one centers across North America have been contracted to perform
the trial, including thirty-seven centers in the United States and four
centers 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
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 Phase 3
Canadian trial for the treatment of moderate to severe psoriasis. ISA247 is
currently being investigated in a combined Phase 3 European/Canadian psoriasis
trial and a Phase 2b North American trial for the prevention of kidney graft
rejection. Our partner, Lux Biosciences has received permission from the Food
and Drug Administration to investigate ISA247 in three separate pivotal
Phase2/Phase 3 trials for the treatment of non-infectious uveitis and as a
maintenance therapy in uveitis. The Company also successfully completed Phase
1 clinical trials of an additional immunosuppressive compound in its drug
Isotechnika Inc. is a publicly traded company on the Toronto Stock
Exchange under the symbol "ISA". More information on Isotechnika can be found
Partnerships with Isotechnika Inc.
Isotechnika Inc. signed a collaboration agreement with Hoffman La Roche
on April 9, 2002, which licensed the worldwide rights to develop and
commercialize 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 commercialize 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 commercialize Isotechnika's lead drug, ISA247
for the treatment and prophylaxis of all ophthalmic diseases.
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.
For further information:
For further information: Dr. Randall Yatscoff, President & CEO,
Isotechnika Inc., Phone: (780) 487-1600 Ext. 246, Fax: (780) 484-4105, Email:
email@example.com; Stephanie Gillis-Paulgaard, Director, Corporate
Communications, Isotechnika Inc., Phone: (780) 487-1600 Ext. 243, Fax: (780)