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Spectrum Pharmaceuticals Initiates Phase 2 Study of Long-Acting GCSF Drug Candidate, SPI-2012, for t

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By Business Wirevia The Motley Fool

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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 …read more

Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

Spectrum Pharmaceuticals Gains Rights to Pivotal-Stage Captisol-Enabled® Melphalan

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By Business Wirevia The Motley Fool

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Spectrum Pharmaceuticals Gains Rights to Pivotal-Stage Captisol-Enabled ® Melphalan

  • Product candidate is being investigated as a conditioning treatment prior to autologous stem cell transplant for patients with multiple myeloma.
  • Melphalan has been granted Orphan designation by the FDA for this indication.
  • In a previous Phase 2 study, Captisol-enabled melphalan had acceptable safety findings, and it met the requirements for establishment of bioequivalence to the current commercial intravenous formulation of melphalan.
  • Spectrum anticipates NDA filing in the first half of 2014 with potential commercial launch the following year, subject to FDA approval.

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 gained global development and commercialization rights to Ligand Pharmaceuticals’ (NAS: LGND) Captisol-enabled®, propylene glycol-free (PG-free) melphalan. Captisol-enabled melphalan is currently in a pivotal trial for use as a conditioning treatment prior to autologous stem cell transplant for patients with multiple myeloma.

Spectrum is assuming the responsibility for the ongoing pivotal clinical trial and will be responsible for filing an NDA, which is anticipated in the first half of 2014. Under the license agreement, Ligand will receive a license fee and is eligible to receive milestone payments, as well as royalties following potential commercialization.

“We are pleased to add this late-stage program to our portfolio, which includes belinostat, for which we anticipate an NDA filing mid-year, and apaziquone, for which we expect to file an NDA in 2014,” stated Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals, Inc. “Captisol-enabled melphalan is designed to meet the need for a formulation of melphalan that is free of propylene glycol, which has been associated with renal and cardiac side effects. The Captisol technology may allow longer duration of administration and slower infusion rates, potentially enabling a higher dose intensity of pre-transplant chemotherapy to optimize efficacy. We look …read more
Source: FULL ARTICLE at DailyFinance