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May 17, 2018 07:00ET|Source:BeyondSpring, Inc.

NEW YORK, May 17, 2018 (GLOBE NEWSWIRE) --BeyondSpring Inc.(NASDAQ:BYSI), a global clinical-stage biopharmaceutical company focused on the development of transformative cancer therapies, today announced that the Company will present results of the Phase 2 portion of Study 105, a prospective Phase 2/3 trial of its lead asset, Plinabulin, during a poster presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting on June 4, 2018. Importantly, data from the study demonstrated that patients treated with Plinabulin dosed 30 minutes after docetaxel for the prevention of docetaxel chemotherapy-induced neutropenia (CIN) reported less bone pain, which was clinically meaningful, and had superior neutrophil counts and comparable neutropenia reduction compared to patients treated with Neulasta(pegfilgrastim) 24 hours after docetaxel. These findings suggest that Plinabulin has the potential for an overall superior product profile in the prevention of CIN.

Study 105 is part of BeyondSprings comprehensive development program for Plinabulin for the prevention of CIN. The Phase 2/3 study was designed as a head-to-head comparison of different dose levels of Plinabulin to Neulasta in a total of 55 patients. Plinabulin was given as a single dose per cycle 30 minutes after docetaxel chemotherapy, while Neulasta was given 24 hours after docetaxel chemotherapy, consistent with its approved product label. The Phase 2 portion met its primary endpoint, which was to determine the recommended Phase 3 Plinabulin dose, and the Phase 3 trial is now underway. Data from the Phase 2 portion, to be included in the poster presentation, are summarized below.

Similar Neutropenia Reduction

Patients treated with one dose of Plinabulin at 20 mg/m2had the same occurrence of severe neutropenia (grade 4) as patients treated with one dose of Neulasta (6 mg) in the first 21-day cycle; grade 4 neutropenia occurred in 14 percent of patients treated with either Plinabulin or Neulasta.

Patients treated with Plinabulin at 20 mg/m2demonstrated the same duration of severe neutropenia (DSN) in the first cycle compared to those treated with Neulasta. The DSN was 0.5 days for patients treated with either Plinabulin or Neulasta. DSN was calculated with an FDA-accepted method for small-sample-size extrapolation.

Plinabulin-Treated Patients Reported Two-Thirds Lower Rate of Bone Pain

Bone pain, which was assessed with a validated questionnaire, occurred in fewer patients treated with Plinabulin at 20 mg/m2(11 percent) compared to patients treated with Neulasta (33 percent). Neulastas ability to treat CIN is based on its mechanistic properties as a granulocyte colony-stimulating factor (G-CSF) that stimulates the expansion and proliferation of neutrophil precursors in the central part (medullary compartment) of bone marrow, which may cause severe bone pain, leading to discontinuation of chemotherapy treatment. In contrast, preclinical studies have shown that Plinabulins mechanism of action differs from G-CSF, allowing it to protect the neutrophil precursors but not induce their proliferation, which may result in less bone pain compared to G-CSF.

Plinabulin Preserved Neutrophil Number in Normal Range

Plinabulin maintained median absolute neutrophil counts (a measure of neutrophils per unit of blood that is calculated from measurements of the total number of white blood cells and bands, or immature neutrophils) within normal range, whereas patients given Neulasta experienced median absolute neutrophil counts higher than the normal range, which can potentially cause bone marrow exhaustion. This provides further evidence of a different mechanism of action with Plinabulin compared to Neulasta for CIN.

The Phase 2 data are extremely encouraging and underscore Plinabulins potential to address unmet needs in the treatment of CIN. These prospective data suggest that Plinabulin, given as a single dose per cycle, would be at least as effective as Neulasta, with the important benefit of causing less bone pain and enabling same-day dosing, compared with the next-day dosing per the G-CSF label. The neutrophil levels observed in this trial are also noteworthy, suggesting a different mechanism of action for Plinabulin compared with G-CSF, said Dr. Douglas Blayney, global Principal Investigator for BeyondSprings CIN development program and Professor of Medicine at Stanford University. The fact that Plinabulin has demonstrated anticancer efficacy in a previous non-small cell lung cancer (NSCLC) Phase 2 studywhich is anticipated to be confirmed in the ongoing NSCLC Phase 3 clinical trialis another distinct advantage. Overall, these differences indicate that Plinabulin has the potential for a superior product profile in the prevention of CIN.

These are the first head-to-head comparison data between Plinabulin and Neulasta. We are highly encouraged by these Phase 2 trial results, and subject to confirmatory Phase 3 trial data, we plan to submit a New Drug Application (NDA) for CIN to the China Food and Drug Administration (CFDA) in late 2018 or early 2019, and a U.S. NDA in 2019, added Dr. Ramon Mohanlal, Chief Medical Officer at BeyondSpring.