Isotechnika Selected for Oral Presentation at the American Transplant Congress
Edmonton, Canada (ots/PRNewswire)
- Trades on Toronto Stock Exchange - (TSX:ISA)
Isotechnika today announced that the Company has been selected to give an oral presentation during the American Transplant Congress in San Francisco, California.
An overview of the latest Phase 2b kidney transplant trial (PROMISE) results will be presented during an oral presentation by Dr. Stephen Busque, one of the principal investigators involved in the PROMISE trial. Dr. Busque's oral presentation is scheduled to take place on Sunday, May 6 at 5:20 p.m. Interested parties will be able to access Dr. Busque's presentation (PDF file format only) by visiting the Company's corporate web site at www.isotechnika.com on Monday, May 7th.
"This oral presentation allow us the opportunity to highlight the latest Phase 2b results to transplant surgeons, physicians, and other health care professionals," stated Dr. Randall Yatscoff, Isotechnika's President & CEO. "The data presented at the American Transplant Congress will demonstrate the favourable safety and efficacy profile of ISA247 in kidney transplantation."
In addition to the oral presentation, Isotechnika will host an evening educational symposium titled "Unleashing the Power of CNi's" 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 organ transplant 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. Results from the 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.
To register or learn more about the symposium please visit www.isotechnika.com/symposium. The formal presentations from the evening symposium will be recorded and available to all interested parties by visiting the Company's corporate web site (www.isotechnika.com) starting Monday, May 7th.
North American Phase 2b Kidney Transplant Trial 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. 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.
About Isotechnika
Edmonton-based Isotechnika Inc. is an international biopharmaceutical company focused on the discovery and development of novel immunosuppressive therapeutics that are safer than currently available treatments. Isotechnika looks to become the leader in development of immunosuppressant therapies. 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 combined Phase 3 European/Canadian psoriasis trial and a Phase 2b North American trial for the prevention of kidney graft rejection. One of our partners, Lux Biosciences, has received permission from the regulatory bodies in the United States, Canada, Austria, Germany, France and the United Kingdom 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.
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 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 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 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.
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)-909-4661, Fax: +1-(780)-484-4105,
E-mail:sgillis-paulgaard@isotechnika.com