Isotechnika Inc.

Isotechnika's Independent Data Monitoring Committee Conducts Review of Phase 2b Kidney Transplant Trial

    Edmonton (ots/PRNewswire) -

    - Company Set to Host Evening Symposium at ATC

    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 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
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 pipeline, TAFA93.         Isotechnika Inc. is a
publicly traded company on  the Toronto Stock Exchange under the
symbol "ISA". More information on  Isotechnika can be found at

    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.

    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.

ots Originaltext: Isotechnika Inc.
Im Internet recherchierbar:

For further information: Dr. Randall Yatscoff, President & COO,
Isotechnika Inc., Phone: +1-(780)-487-1600 Ext. 246, Fax:
+1-(780)-484-4105, Email:; Stephanie
Gillis-Paulgaard, Director, Corporate Communications, Isotechnika
Inc., Phone: +1-(780)-487-1600 Ext. 243, Fax: +1-(780)-484-4105, (ISA.)

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