Edmonton, Canada (ots/PRNewswire) -
- Trades on Toronto Stock Exchange - (TSX:ISA)
Isotechnika today announced that the Company has received a No
Objection Letter from Health Canada for the long term use of ISA247
in patients currently participating in the Canadian arm of the
Company's Phase 2b kidney transplant trial.
The No Objection Letter allows patients to remain on ISA247
through to commercialization of the drug and beyond after completion
of the 12 month Phase 2b trial. Patients choosing to remain on ISA247
therapy will continue to have safety and efficacy parameters
monitored on an ongoing basis. A similar protocol amendment for the
long term use of ISA247 has also been submitted to the Food and Drug
Administration of the United States.
"We submitted the protocol amendment for the long term use of
ISA247 after receiving numerous requests from investigators and
patients currently involved in our kidney transplant trial," said Dr.
Randall Yatscoff, Isotechnika's President & Chief Executive Officer.
Dr. Yatscoff added, "Transplant patients are required to remain on
immunosuppressive therapies for the rest of their lives. It is
expected that the majority of our patients will choose to continue
the use of ISA247. We are excited that our patients have the
opportunity to continue on ISA247 which should make a real
difference in the quality of their lives."
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 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. Patients completing the six month trial will be
given the option to continue therapy for an additional six months.
The objective is to gather long term safety and efficacy data in de
novo transplant patients.
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 CDN$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
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.
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: http://www.presseportal.ch
For further information: Dr. Randall Yatscoff, President & CEO,
Isotechnika Inc., Phone: +1-780-487-1600 Ext. 247, Fax:
+1-780-484-4105, Email: email@example.com; Stephanie
Gillis-Paulgaard, Director, Corporate Communications, Isotechnika
Inc., Phone: +1-780-909-4661, Fax: +1-780-484-4105, E-mail: