Geron announces removal of Full Clinical Hold on Imetelstat
The full clinical hold on Geron’s sole pipeline candidate, investigation new drug (IND), Imetelstat, has been lifted by the FDA. The company does not intend to conduct further studies or develop imetelstat for the treatment of essential thrombocythemia (ET) or polycythemia vera (PV). The development plan is focused on high-risk myeloid malignancies such as myelofibrosis (MF).
The trial had been placed on hold due to reports of liver function abnormalities experienced by patients in previous Phase 2 ET and multiple myeloma trials. The company’s analysis of these data concluded that in the ET trial, liver function test abnormalities resolved to normal or baseline in 14 of 18 follow up patients.
With the lift of full clinical hold, a multi-center Phase 2 clinical trial for MF is projected to start during the first half of 2015. More details can be found here.
Geron announced five abstracts that will be presented at the American Society of Hematology (ASH) Annual Meeting in San Francisco, December 6-9, 2014 – click here for details
Promedior Receives Fast Track Designation for PRM-151 for the Treatment of Myelofibrosis
Promedior, a clinical stage biotechnology company developing novel therapeutics for the treatment of fibrosis, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PRM-151 for the treatment of myelofibrosis (MF), a serious, life-limiting cancer characterized by fibrosis of the bone marrow. This Fast Track designation covers Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, and Post-Essential Thrombocythemia Myelofibrosis. A detailed account of the clinical trial was covered in the MPNforum September 2014 issue, click here.
Promedior Announces Presentation of Phase 2 Data on PRM-151 in Myelofibrosis at the Upcoming ASH Annual Meeting – click here for details.
Orphan Drug Sales show a strong emphasis on Hematologic Cancers
Evaluate Pharma has released their report on orphan drugs and what the landscape will look like in 2020. The top 10 list includes blockbusters by Roche, Celgene, Novartis and Eli Lily – most of these companies are also developing drugs for Myeloproliferative Neoplasms (MPN). Click here for the study.
MPNs are an “orphan disease” – defined as a rare disease that affects a small percentage of the population. While none of the Top 10 list are presently approved for MPNs, this study bodes well for the growing MPN patient population. Here is the Orphan Drug Report 2014 Infographic.