Company on Track to Submit New Drug Application to U.S. FDA and China FDA
NEW YORK, Dec. 06, 2018 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced that the Phase 3 portion of its pivotal Study 105, evaluating its lead asset, Plinabulin, in the 105 enrolled patients treated with docetaxel chemotherapy, has met its primary endpoint of non-inferiority versus Neulasta^® for the duration of severe neutropenia (DSN) of the first cycle, with statistical significance in a pre-specified interim analysis. In this trial, Plinabulin as a single agent was compared head-to-head with Neulasta as a single agent.
Based on the results from this Phase 3 trial, as well as the top line data from the Phase 2 portion of Study 106 released at the recent American Society of Hematology (ASH) Annual Meeting, BeyondSpring now has the necessary data to submit a new drug application (NDA) to the China Food and Drug Administration (China FDA) or National Medical Products Administration (NMPA), for the use of Plinabulin for the treatment of chemotherapy-induced neutropenia (CIN). The Company is also on track to submit an NDA to the U.S. Food and Drug Administration (FDA) for the treatment of CIN. Both submissions will be for broad claims for the treatment of CIN in terms of type of chemotherapy as well as cancer type.
The double-blind, randomized Phase 3 portion of Study 105 was to enroll approximately 150 patients in the U.S., Europe and China with advanced breast cancer, hormone refractory prostate cancer and advanced non-small cell lung cancer (NSCLC), who were randomized to receive docetaxel (75 mg/m^2), with either Plinabulin at a fixed dose of 40 mg on Day 1, or pegfilgrastim (Neulasta) at 6 mg on Day 2 of each 21-day treatment cycle. Plinabulin is administered on the same day of chemotherapy, 30 minutes after chemo administration. Neutrophil count and other hematological parameters were evaluated by Covance Central Laboratory. Covance is also the global clinical CRO for the study for patient enrollment. The primary endpoint of the study was the DSN in the first cycle. A pre-specified interim analysis following approximately 100 patients enrolled was built into the protocol study design to evaluate the primary endpoint of non-inferiority for DSN versus Neulasta.
“Our Study 105 Phase 3 data with Plinabulin as a single agent compares well with Neulasta as a single agent for the prevention of CIN. Single agent Plinabulin had a superior product profile in regard to bone pain, thrombocytopenia protection, and a favorable, non-immunosuppressive phenotype in Study 105 Phase 2 data, which we presented at recent professional society meetings. These collective data demonstrate Plinabulin’s profile as an effective CIN prevention, with a superior product profile,” said Dr. Douglas Blayney, global Principal Investigator for BeyondSpring’s CIN development program and Professor of Medicine at Stanford University School of Medicine.
“This represents a significant milestone for BeyondSpring that illustrates the effectiveness of our development strategy and ability to deliver as promised and ahead of schedule. Coupled with the recently announced positive topline efficacy and safety data from Study 106, BeyondSpring is well-positioned to submit NDAs in both China and the U.S. in the near future, to address the unmet clinical needs of cancer patients,” added Dr. Lan Huang, CEO and co-founder at BeyondSpring.
*About Study 105 Phase 3*
The study evaluated patients with advanced breast cancer, hormone refractory prostate cancer and advanced non-small cell lung cancer and was designed as a multicenter, double blind, randomized study in a head-to-head comparison of Plinabulin at 40 mg with Neulasta at 6 mg, a long-acting G-CSF, in a total of 105 patients. The primary endpoint of the study was the duration of severe neutropenia in the first cycle, and secondary endpoints included the incidence of severe neutropenia, incidence of febrile neutropenia, incidence and duration of hospitalization and bone pain, among others.
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.
*About Plinabulin*
Plinabulin, a marine-derived small-molecule, is BeyondSpring’s lead asset and is currently in late-stage clinical development for the prevention of chemo-induced neutropenia and as an anticancer therapy in non-small cell lung cancer. Studies of Plinabulin's mechanism of action indicate that Plinabulin activates GEF-H1, a guanine nucleotide exchange factor. GEF-H1 activates downstream transduction pathways leading to the maturation of dendritic cells, which in turn leads to T-cell activation and the up-regulate of IL6 in the tissue micro environment, contributing to the prevention of neutropenia.
*About Chemotherapy-Induced Neutropenia*
Chemotherapy-induced neutropenia is a common side effect in cancer patients undergoing treatment that involves the destruction of a type of white blood cell, the neutrophil, which is a patient’s first line of defense against infections. Patients with grade 4 (severe) neutropenia have an abnormally low concentration of neutrophils, making these patients more susceptible to bacterial and fungal infections and sepsis, which can require hospitalization and can be fatal.
The current standard of care for chemotherapy-induced neutropenia prevention is G-CSF monotherapy. However, G-CSF monotherapy has limitations as described in its product information summary. As many as 90 percent of patients on chemotherapy and G-CSF monotherapy may still experience grade 3 or 4 neutropenia. Additionally, as many as 70 percent of patients using G-CSF monotherapy experience bone pain while on therapy. NCCN guidelines require that patients with grade 3/4 neutropenia decrease chemotherapy dose intensity, delay chemotherapy cycle timing or discontinue chemotherapy, each of which can have a negative effect on the long-term outcomes of cancer care.
*About BeyondSpring*
BeyondSpring is a global, clinical-stage biopharmaceutical company developing innovative immuno-oncology cancer therapies with a robust pipeline from internal development and from collaboration with the University of Washington in de novo drug discovery using a ubiquitination platform. BeyondSpring’s lead asset, Plinabulin, is in a Phase 3 global clinical trial as a direct anticancer agent in the treatment of non-small cell lung cancer and two Phase 2/3 clinical programs in the prevention of chemotherapy-induced neutropenia. BeyondSpring has a seasoned management team with many years of experience bringing drugs to the global market.
*Cautionary Note Regarding Forward-Looking Statements*
This press release includes forward-looking statements that are not historical facts. Words such as "will,""expect,""anticipate,""plan,""believe,""design,""may,""future,""estimate,""predict,""objective,""goal," or variations thereof and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on BeyondSpring's current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, difficulties raising the anticipated amount needed to finance the Company's future operations on terms acceptable to the Company, if at all, unexpected results of clinical trials, delays or denial in regulatory approval process, results that do not meet our expectations regarding the potential safety, the ultimate efficacy or clinical utility of our product candidates, increased competition in the market, and other risks described in BeyondSpring’s most recent Form 20-F on file with the U.S. Securities and Exchange Commission. All forward-looking statements made herein speak only as of the date of this release and BeyondSpring undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.
Neulasta^® is a registered trademark of Amgen, Inc.
*Contact:*
*Media Relations:*
Caitlin Kasunich / Amrita Singh
KCSA Strategic Communications
212.896.1241 / 212.896.1207
ckasunich@kcsa.com / asingh@kcsa.com
*Investor Relations:*
Laura Perry / Joe Rayne
Argot Partners
212.600.1902
BeyondSpring@argotpartners.com Reported by GlobeNewswire 5 hours ago.
NEW YORK, Dec. 06, 2018 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced that the Phase 3 portion of its pivotal Study 105, evaluating its lead asset, Plinabulin, in the 105 enrolled patients treated with docetaxel chemotherapy, has met its primary endpoint of non-inferiority versus Neulasta^® for the duration of severe neutropenia (DSN) of the first cycle, with statistical significance in a pre-specified interim analysis. In this trial, Plinabulin as a single agent was compared head-to-head with Neulasta as a single agent.
Based on the results from this Phase 3 trial, as well as the top line data from the Phase 2 portion of Study 106 released at the recent American Society of Hematology (ASH) Annual Meeting, BeyondSpring now has the necessary data to submit a new drug application (NDA) to the China Food and Drug Administration (China FDA) or National Medical Products Administration (NMPA), for the use of Plinabulin for the treatment of chemotherapy-induced neutropenia (CIN). The Company is also on track to submit an NDA to the U.S. Food and Drug Administration (FDA) for the treatment of CIN. Both submissions will be for broad claims for the treatment of CIN in terms of type of chemotherapy as well as cancer type.
The double-blind, randomized Phase 3 portion of Study 105 was to enroll approximately 150 patients in the U.S., Europe and China with advanced breast cancer, hormone refractory prostate cancer and advanced non-small cell lung cancer (NSCLC), who were randomized to receive docetaxel (75 mg/m^2), with either Plinabulin at a fixed dose of 40 mg on Day 1, or pegfilgrastim (Neulasta) at 6 mg on Day 2 of each 21-day treatment cycle. Plinabulin is administered on the same day of chemotherapy, 30 minutes after chemo administration. Neutrophil count and other hematological parameters were evaluated by Covance Central Laboratory. Covance is also the global clinical CRO for the study for patient enrollment. The primary endpoint of the study was the DSN in the first cycle. A pre-specified interim analysis following approximately 100 patients enrolled was built into the protocol study design to evaluate the primary endpoint of non-inferiority for DSN versus Neulasta.
“Our Study 105 Phase 3 data with Plinabulin as a single agent compares well with Neulasta as a single agent for the prevention of CIN. Single agent Plinabulin had a superior product profile in regard to bone pain, thrombocytopenia protection, and a favorable, non-immunosuppressive phenotype in Study 105 Phase 2 data, which we presented at recent professional society meetings. These collective data demonstrate Plinabulin’s profile as an effective CIN prevention, with a superior product profile,” said Dr. Douglas Blayney, global Principal Investigator for BeyondSpring’s CIN development program and Professor of Medicine at Stanford University School of Medicine.
“This represents a significant milestone for BeyondSpring that illustrates the effectiveness of our development strategy and ability to deliver as promised and ahead of schedule. Coupled with the recently announced positive topline efficacy and safety data from Study 106, BeyondSpring is well-positioned to submit NDAs in both China and the U.S. in the near future, to address the unmet clinical needs of cancer patients,” added Dr. Lan Huang, CEO and co-founder at BeyondSpring.
*About Study 105 Phase 3*
The study evaluated patients with advanced breast cancer, hormone refractory prostate cancer and advanced non-small cell lung cancer and was designed as a multicenter, double blind, randomized study in a head-to-head comparison of Plinabulin at 40 mg with Neulasta at 6 mg, a long-acting G-CSF, in a total of 105 patients. The primary endpoint of the study was the duration of severe neutropenia in the first cycle, and secondary endpoints included the incidence of severe neutropenia, incidence of febrile neutropenia, incidence and duration of hospitalization and bone pain, among others.
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.
*About Plinabulin*
Plinabulin, a marine-derived small-molecule, is BeyondSpring’s lead asset and is currently in late-stage clinical development for the prevention of chemo-induced neutropenia and as an anticancer therapy in non-small cell lung cancer. Studies of Plinabulin's mechanism of action indicate that Plinabulin activates GEF-H1, a guanine nucleotide exchange factor. GEF-H1 activates downstream transduction pathways leading to the maturation of dendritic cells, which in turn leads to T-cell activation and the up-regulate of IL6 in the tissue micro environment, contributing to the prevention of neutropenia.
*About Chemotherapy-Induced Neutropenia*
Chemotherapy-induced neutropenia is a common side effect in cancer patients undergoing treatment that involves the destruction of a type of white blood cell, the neutrophil, which is a patient’s first line of defense against infections. Patients with grade 4 (severe) neutropenia have an abnormally low concentration of neutrophils, making these patients more susceptible to bacterial and fungal infections and sepsis, which can require hospitalization and can be fatal.
The current standard of care for chemotherapy-induced neutropenia prevention is G-CSF monotherapy. However, G-CSF monotherapy has limitations as described in its product information summary. As many as 90 percent of patients on chemotherapy and G-CSF monotherapy may still experience grade 3 or 4 neutropenia. Additionally, as many as 70 percent of patients using G-CSF monotherapy experience bone pain while on therapy. NCCN guidelines require that patients with grade 3/4 neutropenia decrease chemotherapy dose intensity, delay chemotherapy cycle timing or discontinue chemotherapy, each of which can have a negative effect on the long-term outcomes of cancer care.
*About BeyondSpring*
BeyondSpring is a global, clinical-stage biopharmaceutical company developing innovative immuno-oncology cancer therapies with a robust pipeline from internal development and from collaboration with the University of Washington in de novo drug discovery using a ubiquitination platform. BeyondSpring’s lead asset, Plinabulin, is in a Phase 3 global clinical trial as a direct anticancer agent in the treatment of non-small cell lung cancer and two Phase 2/3 clinical programs in the prevention of chemotherapy-induced neutropenia. BeyondSpring has a seasoned management team with many years of experience bringing drugs to the global market.
*Cautionary Note Regarding Forward-Looking Statements*
This press release includes forward-looking statements that are not historical facts. Words such as "will,""expect,""anticipate,""plan,""believe,""design,""may,""future,""estimate,""predict,""objective,""goal," or variations thereof and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on BeyondSpring's current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, difficulties raising the anticipated amount needed to finance the Company's future operations on terms acceptable to the Company, if at all, unexpected results of clinical trials, delays or denial in regulatory approval process, results that do not meet our expectations regarding the potential safety, the ultimate efficacy or clinical utility of our product candidates, increased competition in the market, and other risks described in BeyondSpring’s most recent Form 20-F on file with the U.S. Securities and Exchange Commission. All forward-looking statements made herein speak only as of the date of this release and BeyondSpring undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.
Neulasta^® is a registered trademark of Amgen, Inc.
*Contact:*
*Media Relations:*
Caitlin Kasunich / Amrita Singh
KCSA Strategic Communications
212.896.1241 / 212.896.1207
ckasunich@kcsa.com / asingh@kcsa.com
*Investor Relations:*
Laura Perry / Joe Rayne
Argot Partners
212.600.1902
BeyondSpring@argotpartners.com Reported by GlobeNewswire 5 hours ago.
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