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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
www.isotechnika.com.
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.

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, Director, Corporate Communications, Isotechnika
Inc., Phone: +1-(780)-487-1600 Ext. 243, Fax: +1-(780)-484-4105,
E-mail:sgillis-paulgaard@isotechnika.com (ISA.)

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