EDMONTON, April 11 /CNW/ - Isotechnika will host an evening educational
symposium at the American Transplant Congress. The evening symposium titled
"Unleashing the Power of CNi's" will take place on Saturday, May 5th at
7:30 p.m. at the San Francisco Marriott Hotel.
The symposium will highlight the use of ISA247 for the prevention of
transplant organ rejection. The evening will focus on the use of calcineurin
inhibitors, the design of ISA247, and the potential for this design to result
in improvements in both safety and efficacy for transplant and psoriasis
patients. The latest results from the North American Phase 2b kidney
transplant (PROMISE) trial will also be presented. The symposium will also
provide attendees the opportunity to meet clinical trial investigators
currently involved in the Company's PROMISE trial. The topics to be discussed
can be found at www.isotechnika.com/symposium.
"We are pleased to be given the opportunity to host a symposium at one of
the most prestigious transplant meetings worldwide," stated Dr. Randall
Yatscoff, Isotechnika's President & CEO. "This symposium is the perfect forum
to present the potential of ISA247 in transplantation to transplant surgeons
and physicians already familiar with current calcineurin inhibitors."
The formal presentations from the evening symposium will be recorded and
available to all interested parties on Isotechnika's corporate web site by
visiting www.isotechnika.com starting Monday, May 7th.
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 treatment 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 one year. The objective is to gather long term safety and efficacy data in
de novo transplant patients.
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 Phase 2/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
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 voclosporine 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
voclosporine and TAFA93 specifically with drug eluting devices for the
non-systemic treatment of vascular, cardiovascular, target vessel and tissue
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 voclosporine 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,
voclosporine 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:
firstname.lastname@example.org; Stephanie Gillis-Paulgaard, Director, Corporate
Communications, Isotechnika Inc., Phone: (780) 487-1600 Ext. 243, Fax: (780)
484-4105, E-mail: email@example.com