Edmonton, Canada, November 7 (ots/PRNewswire) - Isotechnika Inc.
(TSX: ISA) announced today the unaudited 24 week data for the
Company's Canadian Phase III psoriasis trial for its lead
immunosuppressive drug, ISA247.
A summary of the results is as follows:
- All primary and secondary efficacy endpoints were achieved at 24
- Efficacy endpoints were achieved with minimal side effects
- In the mid- and low-dose groups, continued improvement in PASI
scores were observed from 12 to 24 weeks
- No clinically significant differences in mean serum creatinine
and glomerular filtration rate (GFR) were observed amongst the four
treatment groups at 24 weeks
"We are extremely pleased to have met our endpoints and achieved a
dose that demonstrates a continual increase in efficacy with minimal
effect on renal function," stated Dr. Randall Yatscoff, Isotechnika's
President & CEO. "Again, this positions us well for future clinical
trials with ISA247. This data supports that ISA247, at therapeutic
doses, is efficacious with minimal side effects."
The overall decrease in PASI scores at 24 weeks for the low (0.2
mg/kg twice daily), mid (0.3 mg/kg twice daily) and high (0.4 mg/kg
twice daily) dose groups were 41%, 55% and 70%, respectively. For the
placebo patients that converted to the mid dose group at 12 weeks the
overall decrease in PASI score was 62%. The PASI 50 scores at 24
weeks for the mid (0.3 mg/kg twice daily) and high (0.4 mg/kg twice
daily) dose groups were 56% and 70%, respectively. PASI 75 scores for
the mid and high dose groups were 26% and 49% at 24 weeks. Patients
treated in the mid dose group and low dose group (0.2 mg/kg twice
daily) experienced a continual increase in efficacy over the 24 week
period with minimal effect on renal function. Both the PASI 50 and
PASI 75 scores were statistically significant (p less than 0.05)
versus placebo. In all dose groups, PASI scores exhibited good
Following 24 weeks of treatment, there were no clinically
significant changes noted in the following parameters; hypertension,
cholesterol, triglycerides and infectious complications which is
consistent with the previously released interim report. Additionally,
the incidence of treatment-related adverse events in patients
receiving ISA247 was not different to those receiving placebo.
The mean decrease in glomerular filtration rate at 24 weeks in the
low, mid and high dose groups was 3.0%, 2.8%, and 6.0%, respectively.
This mean percentage change is not clinically significant as it is
within normal analytical and physiological variation. There were no
progressive changes in renal function from 12 to 24 weeks in all dose
groups. Of the 451 patients enrolled in the trial a total of 7
patients, (six in the high dose (7%) and one in the mid dose (1%))
experienced two consecutive greater than 30% decreases in glomerular
filtration rate. Patients originally receiving placebo that were
subsequently crossed over to the mid-dose group at 12 weeks showed no
change in kidney function.
Dr. Robert Bissonnette, a principal investigator involved in the
Phase III SPIRIT trial stated, "Results from patients treated with
ISA247 for 24 weeks confirm its safety and efficacy profile in the
treatment of psoriasis. These results suggest that ISA247 could
become one of our first line systemic treatments for moderate to
Management will provide an overview of the unblinded Phase III
data this morning at 8:00 a.m. EST/6:00 a.m. MST. All Interested
parties can access the live web cast (listen only mode) by going to
Alternatively, you may access the web cast through our corporate Web
site at www.isotechnika.com. The web cast will be archived for a six
month period through the web cast archives at www.newswire.ca.
The Canadian Phase III Psoriasis (SPIRIT) trial commenced on
December 2, 2004. The trial was conducted at 32 sites over a 24 week
period using orally administered ISA247 in psoriatic patients. This
randomized, double-blind trial examined the efficacy of three dosing
groups of ISA247 (0.2 mg/kg, 0.3 mg/kg and 0.4 mg/kg) administered
twice daily compared to placebo with equal numbers of patients
assigned to each of the four treatment groups. The 24 week results
outlined below are based on a total of 451 patients.
About Isotechnika Inc.
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 is an immunosuppressant
currently in an extension protocol of a Canadian Phase III human
clinical trial for the treatment of moderate to severe psoriasis. In
addition, ISA247 has successfully completed a Phase IIa trial for
kidney transplantation. The Company also has an additional
immunosuppressive compound in its drug pipeline, TAFA93 which is in
In addition to the Company's drug pipeline, Isotechnika also has a
diagnostic division, which includes the Helikit(R) and Diatest(R)
breath kits. The Helikit(R) a 13C urea breath test is used for the
detection of H. pylori, a bacterium that infects a large portion of
the population. The Diatest(R) a 13C glucose breath test is used to
measure insulin resistance.
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.
Isotechnika Inc. has a collaboration agreement with Hoffman La
Roche which licensed the worldwide rights to develop and
commercialize Isotechnika's novel molecule ISA247 for all transplant
indications. In addition, the Company has 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
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
Dr. Randall Yatscoff, President & CEO, Isotechnika Inc., Tel:
+1-780-487-1600 Ext. 246, Fax: +1-780-484-4105, Email:
firstname.lastname@example.org; Stephanie Gillis-Paulgaard, Director,
Corporate Communications, Isotechnika Inc., Tel: +1-780-487-1600 Ext.
243, Fax: +1-780-484-4105, E-mail: email@example.com;
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