LONDON, UK / ACCESSWIRE / February 07, 2018 / Active-Investors.com has just released a free research report on Spectrum Pharma, Inc. (NASDAQ: SPPI).If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=SPPI as the Company's latest news hit the wire. On February 05, 2018, Spectrum Pharma, a leading biotechnology Company that works towards acquiring, developing, and commercializing drug products, with a primary focus in Hematology and Oncology, declared that the first Phase-3 study of ROLONTIS, ADVANCE has met its primary endpoint of non-inferiority in Duration of Severe Neutropenia in comparison to pegfilgrastim. Register today and get access to over 1,000 Free Research Reports by joining our site below:

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Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, Spectrum Pharma most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:

www.active-investors.com/registration-sg/?symbol=SPPI

Additionally, the Company also announced that RECOVER, which is its second Phase-3 study for evaluating ROLONTIS has completed enrollment.

About ROLONTIS

ROLONTIS (or eflapegrastim) is Spectrum Pharma's first biological drug. It is a long-acting Granulocyte-Colony Stimulating Factor (G-CSF), which leverages Hanmi Pharmaceutical Company's proprietary platform technology, LAPSCOVERY. Spectrum Pharma had entered into a licensing agreement with Hanmi Pharmaceuticals in January 2012 for gaining global rights for ROLONTIS, except in Korea, China, and Japan.

More often than not, chemotherapy causes myelosuppression, a condition wherein bone marrow activity is decreased, resulting in fewer red blood cells, white blood cells, and platelets. This makes patients prone to infections, hospitalizations, and also interrupts additional chemotherapy treatments. G-CSF helps overcome that situation by stimulating proliferation of granulocyte progenitors and subsequent production of neutrophils in the bone marrow. A recombinant form of G-CSF is administered to cancer patients to accelerate recovery from neutropenia post chemotherapy. Thus, it allows higher-intensity treatment regimens to be given at full-dose and on schedule.

About the Phase-3 ADVANCE Study

Spectrum Pharma initiated ADVANCE, a pivotal Phase-3 study in 2016 to evaluate ROLONTIS in the management of chemotherapy-induced neutropenia. As per the FDA Special Protocol Assessment, the ADVANCE study was a multicenter, randomized, active-controlled trial that enrolled 406 early-stage breast cancer patients, who received docetaxel and cyclophosphamide chemotherapy every 21 days. In the trial, patients were randomized 1:1 to treatment with ROLONTIS or pegfilgrastim. Pegfilgrastim is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (GCSF) analog filgrastim, which works to stimulate the level of white blood cells.

Study Met Primary Endpoints

ROLONTIS met its primary study endpoint in the ADVANCE study, which was non-inferiority in the Duration of Severe Neutropenia in Cycle 1 of chemotherapy, in comparison to pegfilgrastim. The Duration of Severe Neutropenia is when absolute neutrophil counts (ANC) falls below 0.5×109/L. This assessment was based on central laboratory assessment of ANC over the 21-day cycle.

Moreover, the incidence of adverse events in this study was similar to that for pegfilgrastim arms.

The Way Forward for ROLONTIS

The positive top-line data for ROLONTIS is an important milestone for Spectrum Pharma. ADVANCE study confirms the efficacy and safety of ROLONTIS that was observed in the Phase-2 study. Lee S. Schwartzberg, M.D., FACP Professor of Medicine and Division Chief, Hematology Oncology, The University of Tennessee Health Science Center, and Executive Director, UT/West Cancer Center, believes that this drug, if approved, would be a valuable addition to the supportive care treatment options for cancer patients receiving myelosuppressive cytotoxic chemotherapy.

Besides, Spectrum Pharma has also initiated a second Phase-3 study (RECOVER) to help strengthen the regulatory package in the US and Europe. The 218-patient study is now fully enrolled. It would cover sites not only from the US, but also from Europe, Canada, and South Korea. The Company plans to file a Biologics License Application (BLA) in the fourth quarter of 2018.

Stock Performance Snapshot

February 06, 2018 - At Tuesday's closing bell, Spectrum Pharma's stock advanced 2.04%, ending the trading session at $20.99.

Volume traded for the day: 1.16 million shares, which was above the 3-month average volume of 1.15 million shares.

Stock performance in the last month ? up 16.35%; previous three-month period ? up 6.77%; past twelve-month period ? up 310.76%; and year-to-date - up 10.77%

After yesterday's close, Spectrum Pharma's market cap was at $2.16 billion.

The stock is part of the Healthcare sector, categorized under the Biotechnology industry. This sector was up 1.2% at the end of the session.

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