Isotechnika Inc. Announces Promising Results From Phase I TAFA93 Trials
Edmonton, Alberta (ots/PRNewswire)
- Isotechnika Inc. announced today promising results from its Phase I TAFA93 trials. TAFA93, a pro-drug of rapamycin, is a novel small molecule mTOR inhibitor, which is a class of drugs currently used in the prevention of organ rejection in transplantation. mTOR inhibitors are typically used in combination with calcineurin inhibitors after organ transplant. mTOR inhibitors also have potential use in oncology and in cardiac stent technology.
A TAFA93 Phase Ia single center, randomized, placebo-controlled, Single Ascending Dose (SAD) trial commenced in July, 2004. The results indicated that doses of 0.04, 0.08 and 0.16 mg/kg TAFA93 taken once daily were safe and well tolerated in healthy volunteers. No serious adverse events were reported. The data obtained from the Phase Ia trial was used to ascertain the most appropriate dose levels for the Phase Ib clinical trial.
Earlier this year a Phase Ib, single center, randomized, placebo- controlled, Multiple-Ascending Dose (MAD), double-blind trial was conducted with TAFA93. The primary objective of this study was to assess the tolerability, safety and pharmacokinetics of multiple doses of TAFA93 in healthy volunteers. Thirty six subjects were randomized to receive either placebo or oral doses of TAFA93 (0.04, 0.08 or 0.16 mg/kg once daily) for 13 consecutive days.
Overall, the Phase Ib TAFA93 trial suggested that the drug was very well tolerated. No serious adverse events were reported during the trial. TAFA93 administration in the dose range of 0.04 mg/kg to 0.16 mg/kg resulted in dose-proportional rapamycin pharmacokinetics, following both single and multiple doses with stable and linear pharmacokinetics. In addition, the pharmacokinetic profiles display less peak-to-trough variability due to a modified input of the drug, when compared to historical rapamycin data.
The successful completion of the Phase I TAFA93 trials fulfills
one of our commitments to Atrium Medical Corporation ("Atrium") and
allows Atrium to continue moving forward with their drug eluting
stent technology program."Our theory is that having drug concentrations within a therapeutic window for a longer period of time may be beneficial giving immunosuppressive coverage for a more prolonged period of time," stated Dr. Randall Yatscoff, Isotechnika's President and CEO. "These results from these trials are consistent with this theory. This may result in optimized immunosuppressive efficacy and reduced side effects normally associated with this drug class."
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 and a North American Phase IIb human clinical trial for the prevention of kidney graft rejection. The Company also has an additional immunosuppressive compound in its drug pipeline, TAFA93 which is in Phase I.
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's Partnership with Atrium Medical Corporation
In September, 2005, Isotechnika signed an exclusive worldwide licensing agreement for the use of TAFA93 and ISA247 specifically with drug eluting devices for the non-systemic treatment of vascular, cardiovascular disorders, target vessel and tissue disorders.
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:
Dr. Randall Yatscoff, President & CEO, Isotechnika Inc.,
+1(780)-487-1600 (246), +1(780)-484-4105 (fax),
ryatscoff@isotechnika.com; Stephanie Gillis-Paulgaard, Director,
Corporate Communications, Isotechnika Inc., +1(780)-909-4661,
+1(780)-484-4105 (fax), sgillis-paulgaard@isotechnika.com