Myriad Genetics, Inc. (NASDAQ: MYGN) announced today the results of its multi-center, double-blind, placebo-controlled human clinical trial of MPC-7869 (Flurizan™ R-flurbiprofen) in prostate cancer.

The drug had no side effects but nor did it have any positive effect on the patients’ prostate “ancer. The company will not pursue Flurizan™ further for cancer but will continue to look for other uses, primarily for Alzheimer’s disease.

The clinical trial was designed to evaluate the safety of Flurizan™ and to test its efficacy in slowing the rate of progression of prostate cancer among 246 patients with advanced disease.

Efficacy was measured by length of time to systemic disease progression and change in velocity of Prostate Specific Antigen levels.

“Statistical significance was not achieved for either of the endpoints,” Myriad Genetics says. The company “does not intend to pursue further development of this compound in cancer. Myriad will continue to concentrate its efforts on the compound’s demonstrated activity in Alzheimer’s disease.”

Patients participating in the study were assigned to one of three arms: 800 mg once daily or 800 mg twice daily of MPC-7869 or placebo.

The study showed no significant differences in adverse events between the placebo and drug-treated arms. Additionally, during the course of the study, there were no significant differences in serious adverse events between the drug and placebo arms.

Twenty-two patients experienced serious adverse events in the placebo group, compared to 22 in the 800 mg once daily group and 23 in the 800 mg twice daily group. In particular, there were no significant differences between the drug-treated and placebo groups for adverse gastrointestinal, myocardial or cerebrovascular events.

The study showed that MPC-7869 was well tolerated over long-term administration in an elderly population, confirming the data from previous studies. With the completion of this study, Myriad now has over 1,200 patient-years of safety data on this compound, with a maximum exposure period of 44 months.

“The safety data collected in this trial will be very useful to our program in Alzheimer’s disease,” said Peter Meldrum, President of Myriad Genetics, Inc. “The age of the study population is similar and the 800 mg twice daily dose of MPC-7869 is identical to that of our two ongoing Phase 3 trials in Alzheimer’s disease.”

Myriad Genetics, Inc. is a biopharmaceutical company focused on the development 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™ (R-flurbiprofen) is an R-enantiomier (a virtual mirror image) of the NSAID flurbiprofen. Unlike other NSAIDs, at therapeutic concentrations R-flurbiprofen lacks anti-inflammatory activity, and does not inhibit either cyclooxygenase 1 or cyclooxygenase 2 (COX) enzymes. Although this compound lacks activity against COX, studies have shown that this drug is a potent reducer of levels of Beta amyloid, the main constituent of amyloid plaques in Alzheimer’s disease, and therefore there was interest in this drug as a therapeutic agent.

References and Outside Links:

Research on Flurizan and prostate cancer stem cells:
Biochem Pharmacol. 2006 Nov 15;72(10):1257-67. Epub 2006 Sep 1.
Gene expression profiling in R-flurbiprofen-treated prostate cancer: R-Flurbiprofen regulates prostate stem cell antigen through activation of AKT kinase.
Zemskova M, et al. Center for Molecular Biology and Gene Therapy, Loma Linda University, Loma Linda, CA 92354, USA.

Research into Flurizan™ (R-flurbiprofen) for Alzheimer’s disease:

Alzheimer Research Forum (alzforum.org): Flurizan™ Trial info

Mayo Clinic , Jacksonvolle FL press releaseAugust 07, 2003.

CNS Spectr. 2007 Jan;12(12 Suppl 1):1-14. Amyloid-Based interventions in Alzheimer’s disease.
Kennedy GJ, et al. Division of Geriatric Psychiatry, Department of Psychiatry, Montefiore Medical Center, Bronx, NY, USA

J Clin Invest. 2003 August 1; 112(3): 440–449.
NSAIDs and enantiomers of flurbiprofen target γ-secretase and lower Aβ42 in vivo

J Neurochem. 2002 Nov;83(4):1009-12. Links
Selective inhibition of Abeta42 production by NSAID R-enantiomers.
Morihara T et al. Department of Medicine, University of California, Los Angeles, California, USA.