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

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.

About Spectrum Pharmaceuticals, Inc.

Spectrum Pharmaceuticals is a leading biotechnology company focused on acquiring, developing, and commercializing drug products, with a primary focus in oncology and hematology. Spectrum and its affiliates market three oncology drugs ─ FUSILEV® (levoleucovorin) for Injection in the U.S.; FOLOTYN® (pralatrexate injection), also marketed in the U.S.; and ZEVALIN® (ibritumomab tiuxetan) Injection for intravenous use, for which the Company has worldwide marketing rights. Spectrum's strong track record in 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.

Forward-looking statement — This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements are based on management's current beliefs and expectations. These statements include, but are not limited to, statements that relate to our business and its future, including certain company milestones, Spectrum's ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, leveraging the expertise of partners and employees around the world to assist us in the execution of our strategy, and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates may not prove safe or effective, the possibility that our existing and new applications to the FDA and other regulatory agencies may not receive approval in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of sustained revenue history, our limited marketing experience, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company's reports filed with the Securities and Exchange Commission. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.

SPECTRUM PHARMACEUTICALS, INC.®, FUSILEV®, FOLOTYN®, and ZEVALIN®are registered trademarks of Spectrum Pharmaceuticals, Inc and its affiliates. REDEFINING CANCER CARE™ and the Spectrum Pharmaceuticals logos are trademarks owned by Spectrum Pharmaceuticals, Inc.

Neulasta®is a registered trademark of Amgen Inc.

© 2013 Spectrum Pharmaceuticals, Inc. All Rights Reserved.

Spectrum Pharmaceuticals, Inc.
Shiv Kapoor
Vice President, Strategic Planning & Investor Relations

KEYWORDS:   United States  North America  Nevada


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