Myriad Genetics Announces Completion Of Phase 1 Trial Of Anti-Thrombin Drug MPC-0920

Main Category: Vascular
Also Included In: Clinical Trials / Drug Trials
Article Date: 30 Jan 2008 - 1:00 PDT

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Myriad Genetics, Inc. (NASDAQ: MYGN) has completed a Phase 1 human clinical trial of MPC-0920, an orally available, direct thrombin inhibitor. The trial studied healthy volunteers in a single, escalating dose format, to determine the safety, dose range and pharmacokinetics of the drug candidate. The results demonstrate significant biological effect on clotting time and a desirable safety profile following oral administration.

MPC-0920 is designed to address the pressing medical needs for rapid and predictable anticoagulant action, an improved therapeutic window, predictable patient response and increased efficacy. The Phase 1 trial was administered in a single ascending dose format, in which there were eight volunteers per cohort, six of whom are given the drug and two are given placebo. MPC-0920 was shown to be absorbed with a very close correlation between the plasma concentration of drug in plasma and an effect on blood clotting as measured by an increase in pro-thrombin time. There were no apparent drug related adverse events during the study. The primary objectives of the Phase 1 trial were to examine the safety and pharmacokinetics of MPC-0920 and a secondary objective was to study the biological activity of MPC-0920. Unlike most Phase 1 studies, this study showed that a significant biological activity was present and highly correlated to the observed plasma concentration.

In addition to the completed Phase 1 human clinical trial, MPC-0920 has been the subject of 27 preclinical studies to date, comprising safety, toxicity, pharmacokinetics and formulation. MPC-0920 is covered by four issued patents, two U.S. and two foreign.

"We are pleased to report Phase 1 safety data for MPC-0920 and to have demonstrated an effect on clotting time in human volunteers," said Adrian Hobden, Ph.D., President of Myriad Pharmaceuticals, Inc. "Thrombosis is a serious problem and we believe MPC-0920 has the potential to become a significant option in anti-thrombotic therapy."

Myriad intends to aggressively seek a commercial partner for MPC-0920 rather than pursuing further regulatory development independently. The Company's drug development focus remains on its core areas of neurodegeneration, cancer and anti-virals.

The market to treat thrombosis is large, totaling over $6.5 billion in the United States last year, and there is an urgent need for improved drugs, particularly those that can be taken orally. Thrombosis, the formation of a clot within a blood vessel, is one of the most common causes of death in the Western World. Approximately two million individuals in the United States die each year from an arterial or venous thrombosis or its consequences. In addition, thrombosis results in significant morbidity, particularly in the elderly. The most common form of thrombosis is deep-vein thrombosis (DVT) in the leg. This type of clot can break apart, travel up the leg and through the heart, lodging in the lungs and causing blockage of an artery. Known as pulmonary embolism, this condition causes lung tissue death and is an often-fatal complication of DVT. Major indications for MPC-0920 in anti-thrombosis include DVT, atrial fibrillation, artificial heart valves and in major open surgery such as hip replacement, which is increasingly common in older patients.

The drugs currently used to treat this condition are the anticoagulants heparin and warfarin (tradename: Coumadin®). These drugs are widely used. One-third of hospitalized patients in the United States, approximately 12 million in total, receive heparin. However, both drugs have major drawbacks. Heparin requires intravenous administration and blood-level monitoring. Heparin-induced thrombocytopenia -- low platelet count -- is a common serious drug reaction in hospitals. Warfarin is the only orally available anti-thrombotic currently approved for use in the U.S. The use of warfarin is complicated by the fact that it has serious interactions with many commonly used drugs, causing unwanted side effects. It also interacts with compounds found in food. Warfarin can be highly toxic and has a very narrow therapeutic window. Because of the risk of serious side effects, patients are typically monitored twice weekly when they are first put on warfarin. Accordingly, there is a large and urgent unmet medical need for new therapies.

Myriad Genetics, Inc. is a biopharmaceutical company focused on the development of novel healthcare products. The Company develops and markets predictive medicine products, and is developing and intends to market therapeutic products. Myriad's news and other information are available on the Company's Web site at http://www.myriad.com.

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements relating to the demonstrated results of good oral bioavailability, biological effect on clotting time and desirable safety profile; the design and ability of MPC-0920 to address the pressing medical needs for rapid and predictable anticoagulant action, improved therapeutic window, predictable patient response and increased efficacy; the ability of MPC-0290 to be orally available with a very close correlation between the concentration of drug in plasma and an effect on blood clotting as measured by an increase in pro-thrombin time; the Company's belief that MPC-0290 has the potential to become a significant option in anti-thrombin therapy; and the Company's intent to seek a commercial partner for MPC-0920 rather than pursuing further regulatory development independently. These risks and uncertainties include, but are not limited to, the success of MPC-0920 in subsequent clinical trials in demonstrating good oral bioavailability, a biological effect on clotting time and a desirable safety profile; our inability to further identify, develop and achieve commercial success for new products and technologies; our ability to discover drugs that are safer and more efficacious than our competitors; our ability to develop molecular diagnostic products that help assess which patients are subject to greater risk of developing diseases and who would therefore benefit from new preventive therapies; the possibility of delays in the research and development necessary to select drug development candidates and delays in clinical trials; the risk that clinical trials may not result in marketable products; the risk that we may be unable to successfully finance and secure regulatory approval of and market our drug candidates, or that clinical trials will be completed on the timelines we have estimated; uncertainties about our ability to obtain new corporate collaborations and acquire new technologies on satisfactory terms, if at all; the development of competing products and services; our ability to protect our proprietary technologies; patent-infringement claims; risks of new, changing and competitive technologies and regulations in the United States and internationally; and other factors discussed under the heading "Risk Factors" contained in Item 1A in our Annual Report on Form 10-K for the year ended June 30, 2007, which has been filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and Myriad undertakes no duty to update this information unless required by law.

Myriad Genetics, Inc.

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