Geron Corporation (NASDAQ:GERN) reported that the U.S. FDA has granted Fast Track designation to imetelstat for the prospective treatment of adult people with transfusion-dependent anemia following low or Intermediate-1 risk MDS who are non-del and who are resistant or refractory to treatment with an ESA. Imetelstat marks as a telomerase inhibitor initially advanced by Geron and licensed to Janssen Biotech, Inc. on a global basis. Janssen funded the application for Fast Track status using preliminary report from IMerge, the underway clinical trial being performed by Janssen in lower risk MDS.
The FDA’s Fast Track plan is intended to support the development and expedite the assessment of new drugs that are planned to cure grave conditions and supported by data that show the potential to resolve an unmet medical need. Fast Track designation offers opportunities for frequent interactions with the U.S. FDA review staff, including talks to discuss the drug’s development program and to ensure the collection of suitable data required to support nod.
Through the Fast Track Plan, a product candidate may be entitled for priority review, if held by the clinical data, and for the capability to submit completed sections of a NDA on a rolling basis as report becomes available before completion of the full application.
Imetelstat is being assessed in an underway Phase 2/3 clinical study in transfusion dependent patients with Intermediate-1 or Low risk MDS who are refractory or have relapsed after to previous treatment with an ESA. This study is intended in two parts: Part I is a Phase II, open-label, single-arm study while Part 2 is intended to be a Phase III, randomized, controlled study.
Geron reported that as previously reported, 32 patients were registered in Part I of IMerge, of which a subset of 13 people had not obtained prior treatment with either a lenalidomide or hypomethylating agent (HMA) and didn’t have a del chromosomal abnormality.