Spectrum starter phase II studier med SPI-2012

Spectrum Pharmaceuticals har netop startet et nyt phase II studie med deres potentielle storsællrt SPI-2012 der er en forbedring af det idag anvendte NeuLasta. NeuLasta sælger for over 5 mia. $ om året bare i USA, så det er en kæmpe marked som SPI-2012 retter sig imod. Dette phase II studie der forventes fuldt indrullet i 2013, skal bekræfte de positive data fra phase I studiet der viser at SPI-2012 giver bedre effekt end NeuLasta ved 1/3 dosis.

En sidebemærkning er at det var Ken Keller der stod bag udrulningen af NeuLasta og gjorde det til et 5 mia. $ produkt. Ken Keller er nu COO for Spectrum, og det er tydeligt til diverse præsentationer at han er meget begejstret for SPI-2012.

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Spectrum Pharmaceuticals Initiates Phase 2 Study of Long-Acting GCSF Drug Candidate, SPI-2012, for the Treatment of Chemotherapy-Induced Neutropenia

• In U.S.-based Phase 1 trial, SPI-2012 demonstrated increase of        neutrophil count similar to Neulasta^®(pegfilgrastim) at one-third the dose.
• Pending clinical progress and regulatory approval, SPI-2012 will        enter a worldwide market estimated to be over $5 billion.
• Spectrum has global rights for SPI-2012 except for Korea, China,        and Japan.

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, today announced the Company      has initiated a Phase 2 clinical program for SPI-2012 (also referred to      as “LAPS-GCSF”), a drug candidate for the treatment of      chemotherapy-induced neutropenia that utilizes partner Hanmi      Pharmaceutical Company’s proprietary LAPSCOVERY™ Technology. This      technology, as shown in preclinical models, permits greater marrow      penetration and retention of G-CSF when compared to naked CSF and avoids      elimination through kidney. In a previous Phase 1 trial in healthy      volunteers SPI-2012 showed increase in neutrophil count similar to      Neulasta^® (pegfilgrastim) at one-third the dose.

“We are excited to begin mid-stage clinical studies for a drug candidate      that can become a key component of Spectrum’s long-term growth,” said      Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and      President of Spectrum Pharmaceuticals. “Chemotherapy-induced neutropenia      constitutes a large global market estimated to be over $5 billion, and      there is preliminary evidence showing SPI-2012 may have advantages over      the comparator regarding the intensity and duration of neutrophil      recovery. We look forward to the continued study of this product      candidate, which we believe has the potential to address continued unmet      medical needs by studying the opportunity to minimize the risks from      chemotherapy induced neutropenia.”

Spectrum’s phase 2 trial is a multicenter, open label, dose-ranging      study, with a non-inferiority design to compare the effectiveness of      SPI-2012 relative to a fixed and standard dose of pegfilgrastim as a      concurrent active control to each dose of SPI-2012. The primary      objective and endpoint of this study is to assess the effect of test      doses of SPI-2012 on the mean duration of severe neutropenia during      Cycle 1 in patients with breast cancer who are candidates for adjuvant      or neoadjuvant chemotherapy.

In January 2012, Spectrum entered into a co-development and      commercialization agreement with Hanmi, gaining global rights for      SPI-2012 (except Korea, China, and Japan). Hanmi’s LAPSCOVERY™ (Long      Acting Protein/Peptide Discovery) platform technology can be applied to      various molecules including glycosylated proteins, modified or      artificial peptides with unnatural amino acid sequences. LAPSCOVERY™ can      select the optimal conjugation sites from the proteins or peptides to      minimize the structural hindrance and maximize the pharmacological      activity.