Spectrum Pharmaceuticals, Inc. An International Commercial-Stage Biotechnology Company
Spectrum Pharmaceuticals, Inc. An International Commercial-Stage Biotechnology Company
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SPI-2012Spectrum Pharmaceuticals, Inc. An International Commercial-Stage Biotechnology Company

SPI-2012, Spectrum's third biological drug, is a long-acting Granulocyte Colony-Stimulating Factor (G-CSF) that utilizes Hanmi Pharmaceuticals proprietary platform technology, LAPSCOVERY.

G-CSF stimulates proliferation of granulocyte progenitors and subsequent production of neutrophils in the bone marrow. A recombinant form of G-CSF is used in appropriate cancer patients to accelerate recovery from neutropenia after chemotherapy, allowing higher-intensity treatment regimens to be given at full-dose and on schedule. Chemotherapy can cause myelosuppression and unacceptably low levels of white blood cells, making patients prone to infections, hospitalizations, and interruption of additional chemotherapy treatments.

Target Indications

  • Chemotherapy induced neutropenia

Route of Administration

  • Subcutaneous injection

Mode of Action

Binds to the G-CSF receptor expressed on granulocyte progenitors and stimulates their proliferation and subsequent maturation to functionally active neutrophils.

Status

  • Two Phase 1 studies of SPI-2012 have been conducted in healthy volunteers to evaluate the safety, pharmacokinetic and pharmacodynamic properties of SPI-2012.
  • Overall, in the Phase 1 studies in healthy volunteers, it was concluded that SPI-2012 had an acceptable safety profile and increased white blood cell (WBC) and neutrophil counts in a pronounced and dose-dependent manner.
  • A Phase 2 multicenter, dose-ranging study that evaluated the effectiveness and safety of SPI-2012 relative to a fixed, standard dose of pegfilgrastim as a concurrent active control was initiated in 2013 in collaboration with Hanmi Pharmaceuticals.
  • The primary objective and endpoint of this Phase 2 study was to assess the effect of SPI-2012 on the duration of severe neutropenia during Cycle 1 in patients with breast cancer who received adjuvant or neoadjuvant chemotherapy.

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Spectrum Pharmaceuticals, Inc. An International Commercial-Stage Biotechnology Company

Market OpportunitiesSpectrum Pharmaceuticals, Inc. An International Commercial-Stage Biotechnology Company

SPI-2012

SPI-2012 could have potential advantages for more rapid and profound granulocyte recovery in patients with chemotherapy induced neutropenia, a multibillion dollar worldwide market

If SPI-2012 is ultimately commercialized, Spectrum shall own worldwide rights except for Korea, China, and Japan.