Isotechnika Announces Preliminary Phase III Psoriasis Results
Edmonton, Canada (ots/PRNewswire) - Isotechnika Inc. announcedtoday that the Canadian Phase III psoriasis trial for its leadimmunosuppressive drug, ISA247, continues to show promising results.
The Canadian Phase III Psoriasis trial (SPIRIT) which commenced onDecember 2, 2004, includes a total of 453 patients with stablemoderate to severe plaque psoriasis. The trial is currently beingconducted in 32 sites and is the largest of its kind in Canada usingan orally administered systemic medication in psoriasis. Thisrandomised, double-blind, trial examines the efficacy of 3 dosinggroups of ISA247 (0.2 mg/kg, 0.3 mg/kg and 0.4 mg/kg twice daily)over a 24 week period compared to placebo. Equal numbers of patientsare assigned to each of the four treatment groups. The primaryendpoint being investigated is the number of patients achieving a 75%decrease in the Psoriasis Area and Severity Index (PASI) score at 12weeks. Subsequent to the first 12 weeks, those patients who receivedplacebo will be administered the mid-dose of 0.3 mg/kg twice dailyfor the remaining 12 weeks of the study. Patients already receivingactive treatment with ISA247 will remain in their respective dosinggroups for the final 12 weeks until completion of the trial.
Following the 24 week duration of this phase III trial, patientswill be given the opportunity to continue therapy for an additional36 weeks through an extension study. The extension protocol wasdesigned to meet the numerous requests from trial investigatorscurrently involved in the Phase III trial. Patients choosing tocontinue treatment will receive twice daily administration of oralISA247 capsules at 0.3 mg/kg, the mid-dose of the SPIRIT trial. Theprimary reason for the extension study is to gather longer termsafety data to facilitate the advancement of ISA247 through theclinical trial process.
Based on blinded data from 200 patients treated with either ISA247or placebo for at least 12 weeks, PASI scores were, on average,reduced and were comparable to those observed in our previoussuccessful Phase II trial. A clinical response in our current trial,as determined by PASI scores, has been shown in patients as early as4 weeks after starting therapy. Dr. Darryl Toth, a principalinvestigator in the trial from Probity Medical Research states, "Inpatients at my site, I have observed a trend towards a reduction inPASI scores correlating with a decrease in patient's symptoms whichis indicative of good efficacy. Based on my clinical observations todate, the data suggests that ISA247 is an efficacious treatment witha promising safety profile."
"ISA247 belongs to a class of drugs known as 'calcineurininhibitors' and it is well known that other drugs within this classmay have significant negative effects on kidney function," states Dr.Randall Yatscoff, Isotechnika's President & COO. "In addition tomonitoring overall patient safety, we are carefully monitoring kidneyfunction in this trial with ISA247. In particular, we are measuringserum creatinine and determining glomerular filtration rate (GFR), amore accurate measure of kidney function, in all patients. Theblinded data for all patients completing the first 12 weeks oftreatment indicates that kidney function remains stable. Otherlaboratory parameters measured including, for example, cholesterol,triglycerides, and white blood cell count also remained stablethroughout the trial. The current blinded data generated from thefirst half of our phase III trial of ISA247 is encouraging. Wecontinue to look forward to meeting our drug development timelinesfor this important indication."
The management team will provide an overview of the blinded PhaseIII psoriasis data to the investment community this morningcommencing at 9:00 a.m. EDT/7:00 a.m. MDT. All Interested partiescan access the live web cast (listen only mode) by enteringhttp://w.on24.com/r.htm?e=12677&s=1&k=5CCE06914B951157D9FE4209C8A56EFDin their web browser. Alternatively, you may access the web castthrough our corporate Web site at www.isotechnika.com. The web castwill be archived for a 90 day period through the web cast archives atwww.newswire.ca.
About Isotechnika Inc.
Isotechnika Inc. is an international biopharmaceutical companyheadquartered in Edmonton, Alberta, Canada. Drawing upon itsexpertise in medicinal chemistry and immunology, the Company isfocused on the discovery and development of novel immunosuppressivetherapeutics that are safer than currently available treatments. Itsentrepreneurial management and world-class team of scientists arebuilding a pipeline of immunosuppressive drug candidates fortreatment of autoimmune diseases and for use in the prevention oforgan rejection in transplantation. Isotechnika looks to become theleader in development of immunosuppressant therapies.
Isotechnika's lead compound, ISA247 is an immunosuppressantcurrently in a Canadian Phase III human clinical trial for thetreatment of moderate to severe psoriasis. In addition, ISA247 hassuccessfully completed a Phase IIa trial for kidney transplantation.The Company also has two additional immunosuppressive compounds inits drug pipeline, TAFA93 and TKB662 which are in Phase I andpre-clinical respectively.
In addition to the Company's drug pipeline, Isotechnika also has adiagnostic division, which includes the Helikit(R) and Diatest(R)breath kits. The Helikit(R) a 13C urea breath test is used for thedetection of H. pylori, a bacterium that infects a large portion ofthe population. The Diatest(R) a 13C glucose breath test is used tomeasure insulin resistance.
Isotechnika Inc. is a publicly traded company on the Toronto StockExchange under the symbol ISA. More information on Isotechnika can befound at www.isotechnika.com.
This press release may contain forward-looking statements.Forward-looking statements, including the Company's belief as to thepotential of its products, the Company's expectations regarding theissuance of additional patents and the Company's ability to protectits intellectual property, involve known and unknown risks anduncertainties, which could cause the Company's actual results todiffer materially from those in the forward-looking statements. Suchrisks and uncertainties include, among others, the availability offunds and resources to pursue research and development projects, theability to economically manufacture its products, the potential ofits products, the success and timely completion of clinical studiesand trials, the Company's ability to successfully commercialise itsproducts, the ability of the Company to defend its patents frominfringement by third parties, and the risk that the Company'spatents may be subsequently shown to be invalid or infringe thepatents of others. Investors should consult the Company's quarterlyand annual filings with the Canadian commissions for additionalinformation on risks and uncertainties relating to theforward-looking statements. Investors are cautioned against placingundue reliance on forward-looking statements.
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Contact:For further information: Dr. Randall Yatscoff, President & COO, Isotechnika Inc., Phone: +1-780-487-1600 Ext. 246, Fax: +1-780-484-4105, Email: email@example.com; Stephanie Gillis-Paulgaard, Senior Manager, Corporate Communications, Isotechnika Inc., Phone: +1-780-487-1600 Ext. 243, Fax: +1-780-484-4105, E-mail: firstname.lastname@example.org; Archived images on this organization are searchable through CNW Photo Archive website at http://photos.newswire.ca. Images are free to accredited members of the media; To request a free copy of this organization's annual report, please go to http://www.newswire.ca and click on reports@cnw.
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Isotechnika Announces Preliminary Phase III Psoriasis Results