Date: 2017-04-04
Type of
information: Presentation of results at a congress
phase: preclinical
Announcement: presentation of results at the American Association for Cancer Research (AACR) Annual Meeting
Company: Spectrum Pharmaceuticals (USA - NV)
Product: Rolontis™ (eflapegrastim)
Action
mechanism: protein. Eflapegrastim is a long-acting Granulocyte-Colony Stimulating Factor (G-CSF) that utilizes Hanmi Pharmaceutical Co., Ltd. proprietary platform technology, Lapscovery™. It binds to the G-CSF receptor expressed on granulocyte progenitors and stimulates their proliferation and subsequent maturation to functionally active neutrophils.
Disease: chemotherapy-induced neutropenia
Therapeutic
area: Cancer - Oncology - Hematological diseases
Country:
Trial
details:
Latest
news:
- • On April 4, 2017, Spectrum Pharmaceuticals announced the presentation of preclinical data of Rolontis™ (eflapegrastim) from a poster presentation session at the American Association for Cancer Research (AACR) Annual Meeting. Abstract #1347: In vivo efficacy of eflapegrastim in rats with chemotherapy-induced neutropenia: In this study, rats were treated with 50 mg/kg of cyclophosphamide (CPA) intraperitoneally to induce neutropenia. Pegfilgrastim was administered subcutaneously as a single dose of 100 µg/kg on Day 1 and filgrastim was administered subcutaneously at a dose of 20 µg/kg daily for five days on Days 1 to 5. Eflapegrastim was administered subcutaneously as a single dose on Day 1, at doses ranging from 32 µg /kg to 322 µg/kg (or 8.8 µg/kg to 88 µg/kg as G-CSF equivalent). Blood samples were collected for 8 days after drug administration for the measurement of neutrophil counts and the Duration of Severe Neutropenia (DSN).
- Results showed the DSN in neutropenic rats treated with eflapegrastim was compared with the DSN in neutropenic rats treated with pegfilgrastim or filgrastim. The DSN was 0.2 days when eflapegrastim was administered as a single dose at 88 µg/kg (as G-CSF equivalent) 24 hours after administering CPA. In contrast, the DSN was 3.04 days with filgrastim administered at a dose of 20 µg/kg for 5 days from Day 1 to Day 5 and 2.8 days with pegfilgrastim administered as a single dose of 100 µg/kg 24 hours after administering CPA. At the lowest eflapegrastim dose of 8.8 µg/kg that was about 1/10 of G-CSF equivalent dose for pegfilgrastim, the DSN in eflapegrastim-treated rats was 2.94 days. Thus, eflapegrastim was found to be more potent in shortening the DSN with a lower G-CSF equivalent dose when compared to either pegfilgrastim or filgrastim.
Is
general: Yes
