Category: Uncategorized
March 10, 2003

News Release: Isotechnika's Phase II Clinical Trial of ISA247 in Patients With Psoriasis Yields Impressive Results

Isotechnika Inc. today announced that the final data obtained from its Phase II study to evaluate its novel immunosuppressive therapy, ISA247, in patients with moderate to severe psoriasis showed positive results and demonstrated that ISA247 is well tolerated and efficacious. The trial results convincingly showed that ISA247 met or exceeded all of the primary and secondary efficacy and safety endpoints of the study. The primary efficacy endpoint for the study was the achievement of a 2 point reduction of patient Static Global Assessment scores from baseline to the end of the treatment period. In the high dose arm of the study, the data showed that 54% of the patients achieved this parameter (p less than 0.0001) as compared to 17% in the low dose group and 0% in the placebo group. One of the secondary efficacy endpoints for the trial was the achievement of a 75% reduction in Psoriasis Area and Severity Index (PASI) patient scores from baseline to the end of the treatment period. In the high dose arm of the study, the data showed that 74% of the patients achieved this parameter (p less than 0.0001) as compared to 18% for the low dose group and 0% in the placebo group. Further, a 50% reduction in PASI scores was observed in 88% of the patients in the high dose group and 40% of the patients in the low dose patient group. These efficacy results were achieved without any significant adverse effect on blood pressure and lipid levels. The mean serum creatinine levels remained within the acceptable reference range indicating normal kidney function was maintained for all dosing groups. No significant adverse events (SAE) were recorded in the trial, which provided further confirmation of drug safety and tolerability.

"We are thrilled with the results of our latest study in psoriasis patients which continue to confirm the increased potency and lower toxicity of ISA247 when compared with other medications in this class," said Dr. Randall Yatscoff, President and COO. "As expected, the data confirms that within a certain dosage range, ISA247 elicits the desired therapeutic response without significant adverse side effects. This trial's promising results, when confirmed in Phase III studies, clearly differentiates ISA247 from other calcineurin inhibitors and medications currently used in the treatment of psoriasis. In addition, the data clearly shows that this compound provides treatment beyond the field of transplantation to other diseases and disorders, opening up new potential markets for ISA247," said Dr. Yatscoff, "But what really excites us is that this drug has the potential to enhance the health and quality of life of psoriasis patients suffering from the debilitating symptoms of this difficult-to-treat condition."

The psoriasis trial was a double-blinded placebo controlled study performed at twelve centers in Canada with 201 patients participating in total. The twelve week study was randomized with 2 patients receiving the high dose of ISA247 (0.75 mg/kg) twice a day, 2 patients receiving the low dose of ISA247 (0.25 mg/kg) twice a day and 1 patient on placebo. At the end of the study, the patients were monitored for an additional six week period. The primary objectives of the trial were to evaluate the efficacy and safety of ISA247 in the treatment of psoriasis.

The Company will present and discuss the data from the Phase II psoriasis trial as part of the scheduled fourth quarter and year end financials webcast and conference call on Thursday, March 13, 2003 at 11:00 am EST.

Webcast and Conference Call Details

A live webcast (listen only mode) of the conference call will be available at http://webevents.broadcast.com/cnw/isotechnika20030313. To access the live call, please dial (416) 640-4127 (Toronto) or 1-800-814-4861. Callers are encouraged to dial in ten minutes before the call to avoid delays.

A recording of the webcast will be archived for a 90 day period through the webcast archives at www.newswire.ca and on the company website www.isotechnika.com. A recording of the conference call will also be available until midnight on Thursday, March 20, 2003 by calling (416) 640-1917 (Toronto) or 1-877-289-8525 and entering access code 240789 followed by the pound key.

"Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995.

To the extent any statements made in this release contain information that is not historical, these statements are essentially forward looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission.

About Psoriasis

Psoriasis is an auto-immune disease which is prevalent in 1-2 percent of the general population. It is estimated that more than seven million people in the United States alone suffer from this difficult-to-treat condition, with 20-30% of this disease population suffering from moderate to severe psoriasis. In psoriasis, the immune system selectively attacks the skin resulting in inflammation, and the formation of red and potentially painful lesions. These lesions produce red, thickened areas with silvery scales, most often found on the scalp, elbows, knees and lower back. In some cases, psoriasis is so mild that people do not know they have it. In other cases, severe psoriasis may cover large areas of the body. In 2001, the global market for psoriasis medications was estimated at $600 Million USD. With the anticipated introduction of several new treatment therapies, the psoriasis market is projected to grow to more than $3 Billion USD by 2011.

About ISA247

ISA247 is a novel calcineurin inhibitor in Phase II clinical development as immunosuppressive therapy in organ transplantation and in the treatment of autoimmune diseases. Early studies indicate that ISA247 is considerably more potent and far less toxic compared to other immunosuppressants in this class, such as cyclosporin A. This compelling combination of reduced toxicity and improved potency would give a major therapeutic benefit over existing calcineurin based treatments. ISA247 is being developed under a global collaboration agreement with Roche.

About Isotechnika Inc.

Isotechnika Inc. is an international biotechnology company headquartered in Edmonton, Alberta with additional operations in Arizona. The company is focused on the development of immunosuppressive therapeutic drugs for use in organ transplant patients and in the treatment of autoimmune diseases. Its founders and scientific team have developed a novel, multi-platform drug, ISA247, which has progressed through discovery, pre-clinical and Phase II human clinical trials in less than six years. ISA247 is also currently in the final stages of a Phase II human clinical trial in renal transplantation. It has the potential to become the market leader in immunosuppressant therapy; an established market for drugs of this class is in excess of 2.2 billion USD per year globally. Isotechnika Inc. and Roche have signed an agreement for the global co-development and commercialization of Isotechnika's innovative transplant drug, ISA247. Under terms of the agreement, the Company could receive up to an aggregate of $215 million USD comprised of license fees, development and commercial milestones and equity investment. Roche is also responsible for 70 % of the shared development costs of ISA247. The Company will also receive predetermined tiered sales-based royalties at escalating rates upon commercialization of ISA247.

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world's leading research-orientated healthcare groups. The company's two core businesses in pharmaceuticals and diagnostics provide innovative products and services that address prevention, diagnosis and treatment of diseases, thus enhancing people's health and quality of life.

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For further information: Dr. Randall Yatscoff, President & COO,
Isotechnika Inc., (780) 909-5042, (780) 484-4105 (fax),
yatscoffr(at)attcanada.net, Gordon Agopsowicz, Director, Investor Relations,
Isotechnika Inc., (780) 487-1600 Ext. 245, (780) 484-4105 (fax