Spectrum Pharma Highlights Preclinical Data Of ROLONTIS (Eflapegrastim) At The AACR Annual Meeting

• ROLONTIS is currently in a pivotal clinical development program and is on track for Spectrum to file BLA next year.
• Eflapegrastim was more potent than pegfilgrastim at G-CSF equivalent doses in this neutropenic rat model.

HENDERSON, Nev--(BUSINESS WIRE)--Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, announced the presentation of preclinical data of ROLONTIS from a poster presentation session at the American Association for Cancer Research (AACR) Annual Meeting.

“We are excited to see positive data continuing to develop in our highest priority program”

“We are excited to see positive data continuing to develop in our highest priority program,” said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. “The data shows that in this preclinical study eflapegrastim was found to be more potent in shortening the duration of severe neutropenia. Eflapegrastim was more potent than pegfilgrastim at G-CSF equivalent doses in neutropenic animal models. We are currently enrolling patients in our pivotal trial and continue to expect a BLA filing next year.”

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.

About Spectrum Pharmaceuticals, Inc.

Spectrum Pharmaceuticals is a leading biotechnology company focused on acquiring, developing, and commercializing drug products, with a primary focus in Hematology and Oncology. Spectrum currently markets six hematology/oncology drugs, and has an advanced stage pipeline that has the potential to transform the Company. Spectrum’s strong track record for in-licensing and acquiring differentiated drugs, and expertise in clinical development have generated a robust, diversified, and growing pipeline of product candidates in advanced-stage Phase 2 and Phase 3 studies. More information on Spectrum is available at www.sppirx.com.

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