By Aaron Lorenzo

Myriad Genetics Inc. is taking its lead prostate cancer drug to the next step.

The Salt Lake City-based company submitted a multicenter, double-blind, placebo-controlled trial of its prostate cancer drug, Flurizan (MPC-7869), to the FDA.

¿Officially it will be, from the FDA¿s perspective, a [Phase] IIb [trial],¿ said William Hockett, vice president of corporate communications. ¿We consider it a [Phase] II/III, which means that it has the elements of a Phase III in that it is large, it is well controlled, and is statistically powered to demonstrate the endpoints.¿

This new trial is designed to demonstrate the efficacy of Flurizan in prostate cancer patients and will be conducted at 65 U.S. sites. Myriad plans to enroll 400 early stage prostate cancer patients in the study, which is designed to evaluate systemic disease progression of prostate cancer.

¿Enrollment should proceed rapidly because this is a patient population that is not being studied widely,¿ Hockett said. ¿We think we can enroll those approximately 400 patients in six months to maybe nine months, conservatively.¿

Patients will be assigned to one of three regimens ¿ either a once-daily dose of Flurizan, a twice-daily dose or placebo. They will be followed for two years, with primary endpoints including time to metastases and effect on prostate specific antigen (PSA) levels.

The company said it could be in a position to file for approval with the FDA at the study¿s completion.

¿If we demonstrate statistical significance in increasing the time to metastases in prostate cancer patients, then we would file an NDA for approval based on that,¿ Hockett said. ¿We hope that it can be a pivotal trial that can be used as the basis for registration and then approval from the FDA.¿

Myriad has completed two Phase I trials and one Phase IIa trial with Flurizan in healthy volunteers and late-stage cancer patients.

¿The product demonstrated encouraging data in the Phase IIa trial with advanced prostate cancer patients,¿ Hockett said. ¿The primary endpoint of that trial was safety, and the data appear to have demonstrated safety very well. It also had a hint of efficacy in the effect on PSA levels. Although that wasn¿t the primary endpoint, it looked very promising, strong enough to encourage us to move on to a full, large trial such as this one.¿

Flurizan affects a drug target in a novel pathway that may be involved in the regulation of NFkB, a transcriptional activator implicated in cancer and inflammatory diseases. With the drug reaching this late-stage trial, the company continues to make itself over as a biopharmaceutical drug developer of the next generation.

¿Myriad had been perceived in the past as a diagnostic company, or a company with predictive medicine products on the market, which we are,¿ Hockett said. ¿This really helps to demonstrate to people that we have a very strong focus on drug development. Our lead product is in the clinic in what we hope is a pivotal trial. We have two more products that we intend to file INDs on next year. It¿s really a point at which we want to be recognized as a biopharmaceutical company.

¿We have the regulatory personnel in-house, we have a sales force at the other end to take this product to market should it be approved. So, we really have put in all the biostatistics and the additional chemists to take a drug target discovery most all the way through and out to the market.¿

In addition to Flurizan, Myriad features four products in preclinical development, including an advanced program in HIV designed to stop the infection process, a program in acute thrombosis and a compound that addresses colon cancer.

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