Tous Actualités
Suivre
Abonner Isotechnika Inc.

Isotechnika Inc.

FDA Allows Long Term Use of ISA247 in Isotechnika Phase 2b Kidney Transplant Trial

Edmonton, Canada (ots/PRNewswire)

Isotechnika today announced
that the Company has received permission  from the Food and Drug
Administration of the United States (FDA) for the  long term use of
ISA247 in patients currently participating in the  Company's Phase 2b
kidney transplant (PROMISE) trial. The Company  previously announced
in June that it had also received a No Objection  Letter from Health
Canada for the long term use of ISA247 in this trial.
Patients involved in the PROMISE trial are allowed to remain on
ISA247  through to commercialization of the drug and beyond after
completion of the  12 month trial. Patients choosing to remain on
ISA247 therapy will continue  to have safety and efficacy parameters
monitored on an ongoing basis.
"With this approval from the FDA along with the previously
received  approval from Health Canada all patients enrolled in the
PROMISE trial will  have the opportunity to continue on ISA247 for
the long term," stated Dr.  Randall Yatscoff, Isotechnika's President
& CEO. "It is our belief that by  having patients continue to receive
ISA247 therapy we are contributing to  an improved quality of life
subsequent to transplantation. The long term  data received from
these patients will facilitate ISA247 achieving its  commercial
potential."
North American Phase 2b Kidney Transplant Trial Design
Forty-two centers across North America have been contracted to
perform  the trial, including thirty-eight 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 leading
North American 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. The use of the other two
calcineurin inhibitors, cyclosporin and tacrolimus, are often
associated  with significant safety concerns.
A total of 332 de novo (newly transplanted) kidney transplant
patients  have been 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 control arm (0.05 mg/kg
twice daily). 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 dosing
with the drug (ISA247 or tacrolimus) over a six month  period along
with other standard immunosuppressive therapies used following
transplantation.
About Isotechnika
Edmonton-based Isotechnika Inc. is an international
biopharmaceutical  company focused on the discovery and development
of novel immunosuppressive  therapeutics that are designed to offer
advantages over other currently  available treatments while offering
therapeutic choices to clinicians.  Isotechnika looks to become the
market leader of drug therapies for  indications such as
transplantation of solid organs (with Hoffman La Roche)  and
treatment of autoimmune disorders such as uveitis (with Lux
Biosciences) and psoriasis.
There is a significant unmet medical need in the treatment of both
solid organ transplantation and autoimmune disease. It is estimated
that  the market potential exceeds US$ 2 billion annually in sales
for calcineurin  inhibitors such as ISA247.
Isotechnika's lead drug, ISA247, has successfully completed a
Phase 3  Canadian trial for the treatment of moderate to severe
psoriasis. ISA247 is  currently being investigated in a Phase 3
European/Canadian psoriasis trial  and a Phase 2b North American
trial for the prevention of kidney graft  rejection subsequent to
transplantation.
Isotechnika Inc. is a publicly traded company on the Toronto Stock
Exchange under the symbol "ISA". More information on Isotechnika can
be  found at http://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 & CEO,
Isotechnika Inc., Phone: +1-780-487-1600-247, Fax: +1-780-484-4105,
ryatscoff@isotechnika.com; Stephanie Gillis-Paulgaard, Director,
Corporate Communications, Isotechnika Inc., Phone: +1-780-909-4661,
Fax: +1-780-484-4105, sgillis-paulgaard@isotechnika.com

Plus de actualités: Isotechnika Inc.
Plus de actualités: Isotechnika Inc.
  • 23.07.2007 – 15:14

    Isotechnika Completes Patient Recruitment of Pivotal Phase 3 Psoriasis Trial

    Edmonton, Canada (ots/PRNewswire) - Isotechnika Inc. (TSX:ISA) announced today that the Company has completed recruitment of its pivotal Phase 3 European/Canadian psoriasis trial (ESSENCE). As of July 20, 2007, the Company closed recruitment at 638 patients. The patient population is made up of 228 Canadian patients, 294 patients from Germany and 116 patients from ...

  • 27.06.2007 – 15:11

    Isotechnika Achieves Full Enrolment for ISA247 Phase 2b Kidney Transplant Trial

    Edmonton, Canada (ots/PRNewswire) - Isotechnika Inc. (TSX:ISA) announced today the enrolment of the last patient in its Phase 2b trial assessing ISA247 for the prevention of kidney graft rejection following transplantation. Of the 332 patients enrolled, 148 patients have already completed the required six months of treatment. The Company expects to have the last ...