BeyondSpring Initiates Expanded Access Program with Plinabulin for Patients Suffering from CIN in the U.S.
August 11, 2020NCCN Guideline Updates Highlight Need for Maximum CIN Prevention and Resource Allocation for COVID-19 Patients
First Patient Dosed in the U.S. Avoided Grade 4 Neutropenia in Cycle 2 with Plinabulin and Pegfilgrastim, Despite Experiencing Grade 4 Neutropenia in Cycle 1 with Pegfilgrastim Alone
NEW YORK, Aug. 11, 2020 (GLOBE NEWSWIRE) — BeyondSpring Inc. (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies, today announced that the Company has initiated an Expanded Access Program (EAP) to enable doctors across the U.S. to use BeyondSpring’s late-stage asset, Plinabulin, to prevent cancer patients’ chemotherapy-induced neutropenia (CIN), both alone and in combination with G-CSFs (the current standard of care), during the COVID-19 pandemic. Dr. Emad Ibrahim enrolled the first patient at Redlands Community Hospital in California on July 28, 2020.
In response to COVID-19, the National Comprehensive Cancer Network (NCCN) recently updated its treatment guidelines for the prophylaxis of CIN, with the objective of preserving hospital and ER resources for COVID-19 patients and maximizing protection for cancer patients against CIN development. This is designed to help necessitate healthcare interactions, and avoidance of hospital / ER visits will also minimize cancer patients’ risk of contracting COVID-19. In light of these NCCN guideline updates, BeyondSpring initiated an Expanded Access Program to enable the use of Plinabulin by oncologists to better protect cancer patients against CIN with the use of myelosuppressive chemotherapies under the current COVID-19 challenges.
Dr. Emad Ibrahim enrolled the first patient under this EAP at Redlands Community Hospital in California:
This involved a patient with breast cancer receiving standard-of-care chemotherapy (AC). The patient developed Grade 4 neutropenia in Cycle 1 despite the use of Pegfilgrastim at 6mg. When the patient completed Cycle 2 with the Plinabulin and Pegfilgrastim combination, the patient did not develop Grade 4 neutropenia.
“The recent updates to the NCCN guidelines aim to protect cancer patients from developing CIN in the most effective way possible and enable the healthcare system to reserve precious resources for COVID-19 patients,” said Ramon Mohanlal, BeyondSpring’s Chief Medical Officer and Executive Vice President, Research and Development. “In our CIN studies, Plinabulin, in combination with Pegfilgrastim, provided superior protection against CIN, compared to the standard of care alone. The observation in this first EAP patient who completely avoided Grade 4 CIN when given Plinabulin and Pegfilgrastim is a significant achievement for us. At BeyondSpring, we strive to play our part in serving patients and healthcare providers to the highest degree while working through the many challenges imposed by COVID-19.”
Preventing CIN during chemotherapy is extremely important, as this will enable cancer patients to receive the full regimen of chemotherapy and achieve treatment goals. The onset of CIN is the No. 1 reason for treatment modifications, such as downgrading the strength of chemotherapy or stopping chemotherapy altogether. When a patient develops CIN, the treating physician is required to delay the next round of chemotherapy until a patient’s white blood cell count recovers. These changes can have a profoundly negative impact on patient outcomes.
For more information on BeyondSpring’s Plinabulin Expanded Access Program, please visit www.beyondspringpharma.com/EAP/. Supplies may be limited.If you are a physician in the U.S. who would like to request Plinabulin EAP access for your patient, please email expandedaccess@beyondspringpharma.com.
About BeyondSpring Headquartered in New York, BeyondSpring is a global, clinical-stage biopharmaceutical company focused on developing innovative immuno-oncology cancer therapies to improve clinical outcomes for patients with high unmet medical needs. BeyondSpring’s first-in-class lead immune asset, Plinabulin, is a potent antigen-presenting cell (APC) inducer. It is currently in two Phase 3 clinical trials for two severely unmet medical needs indications: one is for the prevention of chemotherapy-induced neutropenia (CIN), the most frequent cause for a chemotherapy regimen dose’s decrease, delay, downgrade or discontinuation, which can lead to suboptimal clinical outcomes. The other is for non-small cell lung cancer (NSCLC) treatment in EGFR wild-type patients. As a “pipeline drug,” Plinabulin is in various I/O combination studies to boost PD-1 / PD-L1 antibody anti-cancer effects. In addition to Plinabulin, BeyondSpring’s extensive pipeline includes three pre-clinical immuno-oncology assets and a drug discovery platform dubbed “molecular glue” that uses the protein degradation pathway.
About Plinabulin Plinabulin, BeyondSpring’s lead asset, is a differentiated immune and stem cell modulator. Plinabulin is currently in late-stage clinical development to increase overall survival in cancer patients, as well as to alleviate chemotherapy-induced neutropenia (CIN). The durable anticancer benefits of Plinabulin have been associated with its effect as a potent antigen-presenting cell (APC) inducer (through dendritic cell maturation) and T-cell activation (Chem and Cell Reports, 2019). Plinabulin’s CIN data highlights the ability to boost the number of hematopoietic stem / progenitor cells (HSPCs), or lineage-/cKit+/Sca1+ (LSK) cells in mice. Effects on HSPCs could explain the ability of Plinabulin to not only treat CIN but also to reduce chemotherapy-induced thrombocytopenia and increase circulating CD34+ cells in patients.
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.
RECENT NEWS ARTICLES
BeyondSpring and Leading Cancer Center to Present Poster at 2023 ASCO Annual Meeting
NEW YORK, May 18, 2023 – BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a global clinical-stage biopharmaceutical company focused on using a groundbreaking technology platform for drug discovery and developing innovative therapies to improve...
BeyondSpring Files 2022 Annual Report on Form 20-F
NEW YORK, April 18, 2023 – BeyondSpring Inc. (the “Company” or “BeyondSpring”) (Nasdaq: BYSI), a clinical-stage global biopharmaceutical company focused on using its novel technology platform for drug discovery and development of innovative therapies to improve...
BeyondSpring Provides Business Update and Reports Year End 2022 Financial Results
SEED Therapeutics, a BeyondSpring Subsidiary, Achieved Milestones on the Eli Lilly Collaboration BeyondSpring Completed Enrollment of Three Investigator-Initiated Trials (IIT) with Plinabulin in the U.S. for Multiple Cancer Indications NEW YORK, April 18, 2023 –...
BeyondSpring Enrolls First Patient in Phase 2 Study with Plinabulin, Keytruda and Docetaxel in Patients with Metastatic Non-Small Cell Lung Cancer Who Progressed After Immunotherapy
NEW YORK, March 1, 2023 – BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a clinical-stage global biopharmaceutical company focused on developing innovative cancer therapies, today announced that the first patient has been enrolled in...
BeyondSpring Receives Notifications from Nasdaq Regarding Compliance With Listing Rules
NEW YORK, January 9, 2023 – BeyondSpring Inc. (the “Company” or “BeyondSpring”) (Nasdaq: BYSI), a clinical stage global biopharmaceutical company focused on developing innovative cancer therapies, today announced that on December 29, 2022, the Company received a...
BeyondSpring Presents Positive Data with Plinabulin for the Prevention of Docetaxel-Induced Neutropenia in Patients with Non-Small Cell Lung Cancer and Breast Cancer at Three Medical Conferences
Additional analyses of non-small cell lung cancer (NSCLC) studies support the efficacy of plinabulin monotherapy in reducing the mean duration of severe neutropenia (DSN) for patients receiving docetaxel In an analysis of breast cancer patients, plinabulin monotherapy...
BeyondSpring Receives Nasdaq Notice Regarding Minimum Bid Price Requirements
NEW YORK, November 23, 2022 – BeyondSpring Inc. (the “Company” or “BeyondSpring”) (Nasdaq: BYSI), a clinical stage global biopharmaceutical company focused on developing innovative cancer therapies, today announced that on November 18, 2022, it received...
BeyondSpring Presents New Clinical Evidence of Plinabulin Protection of Granulocyte-Monocyte Progenitor Stem Cells for the Prevention of Chemotherapy-Induced Neutropenia at the ESMO Congress 2022
Plinabulin rapidly (within 24 hours) mitigates chemotherapy-induced myelosuppression by protecting bone marrow granulocyte-monocyte progenitor (GMP) stem cells NEW YORK, September 13, 2022 – BeyondSpring Inc. (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a...
BeyondSpring Presents New Data for the Use of Plinabulin and Pegfilgrastim to Decrease Neutropenia Burden in Peri-Transplant Multiple Myeloma Patients at the 19th International Myeloma Society Annual Meeting
Plinabulin was well tolerated and only one out of the 10 patients enrolled had non-engraftment related neutropenic fevers or febrile neutropenia (FN) with the plinabulin/pegfilgrastim combination NEW YORK, August 29, 2022 – BeyondSpring Inc. (the “Company” or...
BeyondSpring Presents New Clinical Data in the Chemotherapy-Induced Neutropenia and NSCLC Programs at the 2022 ASCO Annual Meeting
NEW YORK, May 27, 2022 – BeyondSpring Inc. (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a clinical stage global biopharmaceutical company focused on developing innovative cancer therapies to improve clinical outcomes for patients who have a high unmet medical...
RECENT MEDIA COVERAGE
TD Ameritrade Watch List
Read More
Managing Chemotherapy Toxicities for Improved Patient Outcomes
Read More
New Treatment Modalities: Protein Degraders And Molecular Glues Gain Traction
Read More
Seed Therapeutics blossoms in an $800M deal with Lilly
Read More
Seed Therapeutics Launches Protein Degradation Research Platform and Appoints Edward Dongheng Liu as Chief Financial Officer
Read More
BeyondSpring Forms Partnership Advisory Committee Comprised of Industry Veterans
Read More
JAMA Oncology Highlights Plinabulin’s Efficacy in Preventing Chemotherapy-Induced Neutropenia as a Monotherapy
Read More