Bolder BioTechnology Announces Initiation of Phase 1 Clinical Trial of BBT-015 for Treating Neutropenia and Acute Radiation Syndrome

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Aug 02, 2017, 08:26 ET

BOULDER, Colo., Aug. 2, 2017 /PRNewswire/ -- Bolder BioTechnology, Inc. announced today that it has commenced dosing of patients in a Phase 1 clinical trial of its proprietary long-acting granulocyte colony-stimulating factor (G-CSF) analog, BBT-015. The trial is designed to study the pharmacokinetics, pharmacodynamics, safety and tolerability of single subcutaneous doses of BBT-015 in healthy human subjects. BBT-015 is being developed as a treatment for chemotherapy-related neutropenia in cancer patients and for Acute Radiation Syndrome.

Joe Cox, Ph.D., Bolder BioTechnology's President said: "Initiation of this clinical trial represents a major milestone for Bolder BioTechnology and the culmination of many years of effort by our dedicated and talented employees."

"BBT-015 is a novel G-CSF analog that exhibits a longer duration of action and greater potency than other G-CSF products. In preclinical studies, BBT-015 stimulated larger and longer-lasting increases in neutrophils, and faster neutrophil recovery in chemotherapy-treated, neutropenic animals compared to other G-CSF products. BBT-015 also significantly increased survival and accelerated recovery of neutrophils, platelets, and red blood cells in animals exposed to lethal doses of radiation, even when administered 24 hours following radiation exposure."

"BBT-015's increased potency and longer duration of action may stimulate faster neutrophil recovery in cancer patients and / or allow the drug to be administered less frequently and at lower doses than competing G-CSF products, with associated cost savings for patients."

"G-CSF products are some of the best selling biopharmaceuticals in the world, with annual worldwide sales exceeding $6 billion, primarily from the treatment of neutropenia in cancer patients."

About BBT-015
BBT-015 is a long-acting G-CSF analog produced using site-specific PEGylation technology. G-CSF is a human protein that stimulates production of neutrophils, a type of white blood cell that is important for fighting infections. G-CSF has a short half-life in humans and typically is administered to patients by daily injection. BBT-015 has been selectively modified with the polymer polyethylene glycol at a unique site in the protein, which allows the protein to last longer in patients, reducing the need for frequent administration and increasing the protein's ability to stimulate long-lasting production of neutrophils.

About Chemotherapy-Related Neutropenia
Neutropenia (severely reduced numbers of neutrophils) is a common side effect of chemotherapy treatment in cancer patients. Neutropenia increases the patient's risk of developing serious bacterial infection and requiring expensive hospitalization. G-CSF products are commonly administered to cancer patients following chemotherapy to accelerate neutrophil recovery and decrease the length of time that patients are neutropenic.

About Acute Radiation Syndrome
Acute Radiation Syndrome, often referred to as radiation sickness, is a collection of illnesses that occurs following exposure to high doses of ionizing radiation within a short period of time, such as might occur following an accident at a nuclear power plant or detonation of a nuclear weapon. Bone marrow, which is responsible for producing new blood cells, is one of the most radiation-sensitive tissues, and subjects acutely exposed to high doses of radiation typically develop bone marrow aplasia and severe neutropenia and thrombocytopenia (low numbers of platelets) within a few weeks of exposure, Many subjects die from infections due to a lack of neutrophils, or from uncontrolled bleeding due to a lack of platelets.

About Bolder BioTechnology
Bolder BioTechnology, Inc. is a private company that uses advanced protein engineering technologies to create proprietary human protein pharmaceuticals with enhanced therapeutic properties for the treatment of hematopoietic and endocrine disorders, cancer and infectious diseases. For additional information about Bolder BioTechnology, Inc., please visit our web site at www.bolderbio.com.

Government Support
Preclinical research reported in this press release was supported by The National Cancer Institute and The National Institute of Allergy and Infectious Diseases of the National Institutes of Health under awards R43CA078094, R44CA078094, R43AI084288, R44AI084288, and U01AI107340. The content of this press release is solely the responsibility of Bolder BioTechnology and does not necessarily represent the views of the National Institutes of Health.

Forward Looking Statements
Statements contained herein that are not historical facts are forward-looking statements that are subject to a variety of risks and uncertainties. There are a number of important factors that could cause actual results to differ materially from those expressed in any forward-looking statements made by the Company. These factors include, but are not limited to: (1) the Company's ability to successfully complete product research and development, including pre-clinical and clinical studies, and commercialization; (2) the Company's ability to obtain required government approvals; (3) the Company's ability to attract and/or maintain manufacturing, sales, distribution and marketing partners; and (4) the Company's ability to develop and commercialize its products before its competitors.

SOURCE Bolder BioTechnology, Inc.