FDA has conditionally approved a proprietary prognostic genetic test by Signal Genetics Inc, the Myeloma Prognostic Risk Signature (MyPRS), for use as an entry criterion for an upcoming clinical trial sponsored by the University of Arkansas for Medical Sciences (UAMS) to treat high-risk multiple myeloma (MM) patients.

FDA required and subsequently conditionally approved an investigational device exemption for Signal’s prognostic test to be used in conjunction with the trial of an investigational new drug filed by UAMS. The drug is intended to improve clinical outcomes for newly diagnosed MM patients with high-risk disease as defined by gene expression profiling (GEP).

Headquartered in Carlsbad, Calif, Signal Genetics is a commercial stage, molecular diagnostic company focused on providing innovative diagnostic services that help physicians make better-informed decisions concerning the care of their patients suffering from cancer. The company’s mission is to develop, validate, and deliver innovative diagnostic services that enable better patient-care decisions. Signal was founded in January 2010 and became the exclusive field licensee for UAMS research on multiple myeloma in April 2010.

The UAMS trial is titled “2012-02 total therapy 5B: A phase II trial for high-risk myeloma, evaluating accelerating and sustaining complete remission (AS-CR) by applying non-host-exhausting and timely dose-reduced MEL-80-CFZ-TD-PACE transplant(s) with interspersed MEL-20-CFZ-TD-PACE with CFZ-RD and CFZ-D maintenance.”

The Phase II trial will assess safety and efficacy of the investigational treatment regimen, using MyPRS to qualify which patients are considered to have GEP-defined high-risk MM. The 3-year investigation is limited to 45 subjects enrolled at a single testing site in the United States (approximately 60 subjects screened and 14 subjects enrolled per year).


Gareth Morgan, MD, PhD, University of Arkansas for Medical Sciences

“We are excited to begin this Phase II trial to treat high-risk multiple myeloma patients by applying more frequent, but lower doses of chemotherapy,” says Gareth Morgan, MD, PhD, professor of medicine and director of the Myeloma Institute at UAMS. “The use of MyPRS to aid in the selection of high-risk MM patients is critical to this trial.”

The conditional IDE approval requires UAMS to provide FDA with further information over the next 45 days. However, UAMS is allowed to begin enrollment of the trial based upon MyPRS results, immediately after UAMS has obtained approval from its institutional review board (IRB) and submitted the certification of approval to FDA.

“This is a significant milestone for Signal Genetics, as it brings us a step closer to our goal of gaining companion diagnostic status for MyPRS, our novel prognostic test,” says Samuel D. Riccitelli, Signal’s president and chief executive officer. “In addition, we believe this is further validation of our test and its ability to aid in the treatment of multiple myeloma patients, especially during this time in which regulation and scrutiny regarding laboratory developed tests have continued to increase.

“We are excited to be expanding our work with UAMS, our longstanding partner, and look forward to advancing to the next stages of diagnostic development and commercialization as we work toward improving the care of patients suffering from this severe form of cancer.”

“UAMS and Signal Genetics have reached a major accomplishment and believe that with the recent IND filing and receipt of a conditionally approved IDE for MyPRS, we have demonstrated to FDA the potential benefits of our work for the MM patient population,” Morgan adds. “We also believe the new clinical trial will provide further evidence for the need of physicians to make better-informed treatment decisions in order to improve patient survival rate and quality of life.”