Date: 2017-01-05
Type of information: update on patient enrollment
phase: 1-2
Announcement: update on patient enrollment
Company: Stemline Therapeutics (USA - NY)
Product: SL-401 - recombinant human interleukin-3 truncated diphtheria toxin fusion protein
Action
mechanism: fusion protein. SL-401 is a targeted therapy directed to the interleukin-3 receptor (IL-3R) present on CSCs and tumor bulk of a wide range of hematologic cancers. Three multicenter clinical trials with SL-401 are currently open in seven indications. SL-401 is currently completing the lead-in stage of the pivotal trial in blastic plasmacytoid dendritic cell neoplasm (BPDCN). Clinical studies with SL-401 are also open in additional hematologic indications including acute myeloid leukemia (AML) in first complete remission (CR) with minimal residual disease (MRD), relapsed/refractory AML, and four types of advanced high-risk myeloproliferative neoplasms (MPN), including systemic mastocytosis, advanced symptomatic hypereosinophilic disorder, myelofibrosis, and chronic myelomonocytic leukemia. Previously, SL-401 demonstrated single-agent activity, including multiple durable CRs, in a Phase 1/2 trial in BPDCN and relapsed/refractory AML.
Disease: blastic plasmacytoid dendritic cell neoplasm
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: This is a non-randomized, open-label, multi center study. A cycle of therapy is 5 consecutive days every 21 days for 6 or more cycles. Stage I will consist of a brief run-in period in which patients with BPDCN (previously untreated and previously treated) and AML (persistent/recurrent and previously untreated) will be treated with SL-401 at 3 dose levels. During Stage 2, two cohorts of BPDCN and AML patients will be treated at the maximum tolerated dose or maximum tested dose in which multiple dose-limiting toxicities are not observed (identified in Stage 1). ( NCT02113982)
Latest
news: * On January 5, 2017, Stemline Therapeutics announced an agreement with the FDA on the registration pathway for SL-401 in blastic plasmacytoid dendritic cell neoplasm. To support the filing of a Biologics License Application (BLA) for full approval in first-line BPDCN, Stemline is currently enrolling an additional small cohort, planned for 8-12 first-line BPDCN patients, into its ongoing Phase 2 trial. To date, approximately half of these new patients are enrolled into the study, with full enrollment expected this quarter. * On March 13, 2014, a Phase 1-2 trial sponsored by Stemline Therapeutics was published on the NIH website ClinicalTrials.gov for SL-401 and is currently recruiting participants.
