42% of Patients on Flurizan™ Had Improved or Not Declined After 24 Months
SALT LAKE CITY, UT, March 05, 2007—Myriad Genetics, Inc. (NASDAQ: MYGN) (www.myriad.com) announced today that it presented additional results of its completed Phase 2 follow-on study of Flurizan™ in patients with mild Alzheimer's disease at the annual meeting of the American Association for Geriatric Psychiatry (AAGP), held March 1-4, 2007 in New Orleans. The data indicate that Flurizan may be capable, not only of slowing the decline of Alzheimer's disease, but of halting the disease in its tracks. In this study, many patients with Alzheimer's disease got no worse over two full years, and in some cases, patients treated with Flurizan appear to have improved.
At 24 months, study participants in the Phase 2 trial with mild Alzheimer's disease taking 800 mg twice daily Flurizan experienced a 67% improvement in their level of cognitive decline compared with placebo, as measured by the Mini Mental State Exam (MMSE) score. This difference was highly significant statistically (p=0.001). Additionally, based upon the MMSE score, three times the percentage of patients on Flurizan demonstrated improvement in cognition or zero decline, compared to patients on placebo: Forty-two percent of patients on 800 mg twice daily Flurizan experienced improvement or zero decline, compared with 14% of patients taking placebo. MMSE is the primary test used by most clinicians to help diagnose, assess and monitor progression of patients with Alzheimer's disease. It was also the principal criterion for selecting patients to enroll in the Phase 2 study, and is a secondary endpoint in the two ongoing Phase 3 trials of Flurizan.
Overall, 42% of patients on Flurizan showed improvement or no decline in one or more of the three primary endpoints of cognition, global function and activities of daily living, compared to 10% of patients on placebo. On the test that measures cognition, ADAS-cog, 25% of study participants taking 800 mg BID of Flurizan showed cognitive improvement or experienced zero decline in cognition after 24 months, compared with none on placebo. With the CDR-sb test, a measure of overall function in Alzheimer's patients, 29% of study participants on Flurizan experienced an improved or zero decline score, compared with none of those on placebo.
Robert C. Green, M.D., MPH, Co-Director, Alzheimer's Disease Clinical & Research Program, Professor of Neurology, Genetics and Epidemiology at the Boston University School of Medicine, and a lead investigator on the Phase 3 trial of Flurizan, commented, "This analysis of patient response to Flurizan in the Phase 2 trial suggests that the drug may, in many patients, actually halt disease progression over a 24-month time frame. Since Flurizan appears to slow the biological progression of the disease, this is an exciting and novel finding, and if replicated in the ongoing Phase 3 trials will be extraordinarily important."
To recap the efficacy results of the Phase 2 study at month 24 presented earlier, mild patients taking 800 mg of Flurizan twice daily had an effect size of 72%, with a statistically significant value of p=0.0005, as measured by their global function on the CDR-sb test. In activities of daily living, the patients showed a statistically significant 67% effect size (p=0.015). Cognition improvement showed an effect size of 52% at 24 months on the ADAS-cog scale. These data suggest that there is a substantial benefit from Flurizan.
The additional data presented at the AAGP meeting and announced today add detail to these effect sizes by demonstrating that, not only did the population as a whole respond to the treatment, but a meaningful portion of the patients who responded to the treatment did so by experiencing either zero decline after two years or a reversal of their decline to actual improvement, something that is very rare in Alzheimer's disease. Comparisons to placebo at 24 months refer to the placebo group as originally randomized.
The vast majority of patients in this Phase 2 study, approximately 94% at the time of enrollment, were receiving stable doses of acetylcholinesterase inhibitors, which are FDA-approved drugs for symptomatic treatment of Alzheimer's disease. Thus, the benefits of Flurizan observed in these patients were over and above the current standard of care.
"The 24 month Phase 2 responder analysis provides further evidence of efficacy against mild Alzheimer's disease that is consistent with our understanding of Flurizan's mechanism of action as a SALA," said Adrian Hobden, Ph.D., President of Myriad Pharmaceuticals, Inc. "The results support our belief that Flurizan is modifying the course of the underlying disease process."
Myriad has two Phase 3 trials of Flurizan ongoing in patients with mild Alzheimer's disease. In each study, participants are taking 800 mg of Flurizan or placebo twice daily, and the last participant enrolled will have taken the study drug for 18 months. Flurizan is the first in a new class of drug candidates known as Selective Amyloid beta-42 Lowering Agents (SALAs). Flurizan lowered levels of Abeta42 in cellular assays and animal models. Abeta42 is the primary constituent of senile plaque that accumulates in the brain of patients with Alzheimer's disease. It is thought to be the key initiator of Alzheimer's disease, since Abeta42 has the greatest tendency to aggregate, cause neuronal damage and initiate amyloid deposits in the brain. Most genetic mutations that cause early-onset Alzheimer's disease appear to do so by increasing production of Abeta42. Myriad believes that Flurizan is the most advanced drug candidate that modifies the production of Abeta42 to be evaluated in a clinical trial for the treatment of Alzheimer's disease.
Myriad Genetics, Inc. is a biopharmaceutical company focused on the development and marketing of novel healthcare products. The Company develops and markets molecular diagnostic 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 www.myriad.com. Flurizan is a trademark of Myriad Genetics, Inc. in the United States and other countries.
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include: the capacity of Flurizan to not only slow the decline of Alzheimer's disease, but halt the disease in its tracks; the suggestion that patients on Flurizan with Alzheimer's disease will get no worse, and in some cases reverse the course of the disease, resulting in patient improvement; the showing of improvement or no decline of patients on Flurizan on one or more of the three primary endpoints of cognition, global function and activities of daily living; the suggestion that Flurizan may, in many patients, actually halt disease progression over a 24-month time frame; the appearance that Flurizan slows the biological progression of the disease, and the extraordinary importance of this finding if replicated in the ongoing Phase 3 trials; the suggestion that there is a substantial benefit from Flurizan; the demonstration that not only did the population as a whole respond to the treatment, but a meaningful portion of the patients who responded to the drug did so by experiencing either zero decline after two years or a reversal of their decline to actual improvement; the efficacy of Flurizan against Alzheimer's disease consistent with the understanding of Flurizan's mechanism of action as a SALA; the Company's belief that Flurizan is modifying the course of the underlying disease process; the appearance that Flurizan is modifying the underlying course of the disease process; the continued encouragement of the Company by the potential of Flurizan to treat mild Alzheimer's disease; the anticipated completion of the Phase 3 trial, in order to confirm similar efficacy results for Flurizan in a larger population; the anticipated completion of enrollment of patients with mild Alzheimer's disease in a global Phase 3 trial; and the belief that Flurizan is the most advanced drug candidate in a clinical trial that inhibits the production of Abeta42 to be evaluated in a clinical trial for the treatment of Alzheimer's disease. These forward-looking statements are based on management's current expectation and are subject to certain risks and uncertainties that could cause actual results to differ materially from those set forth or implied by forward-looking statements. These include, but are not limited to, uncertainties as to the extent of future government regulation of Myriad Genetics' business; uncertainties as to whether Myriad Genetics and its collaborators will be successful in developing, and obtaining regulatory approval for, and commercial acceptance of, therapeutic compounds; the risk that markets will not exist for therapeutic compounds that Myriad Genetics develops or if such markets exist, that Myriad Genetics will not be able to sell compounds, which it develops, at acceptable prices; and the risk that the Company will not be able to sustain revenue growth for its predictive medicine business and products. These and other risks are discussed under the heading "Risk Factors" contained in Item 1A in our Annual Report on Form 10-K for the year ended June 30, 2006, 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 this release, and Myriad undertakes no duty to update this information unless required by law.
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