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CBLB502
Entolimod (CBLB502) is being developed by Cleveland Biolabs, Inc. for dual indications under the U.S. Food & Drug Administration’s (FDA) animal efficacy rule as a pivotal-stage radiation countermeasure, and under the FDA’s traditional drug approval pathway as a cancer treatment. Entolimod is a recombinant protein that acts as an agonist of toll-like receptor 5 (TLR5), an innate immunity receptor. Entolimod activation of TLR5 triggers NF-κB signaling, mobilizing an innate immune response that drives expression of numerous genes, including inhibitors of apoptosis, scavengers of reactive oxygen species, and a spectrum of protective or regenerative cytokines. Radiation countermeasure The FDA established the animal efficacy rule in 2002 to permit the approval of certain drugs and biologics that are intended to reduce or prevent serious or life-threatening conditions based on evidence of safety from trial in healthy subjects and effectiveness from appropriate animal studies wh ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Cleveland BioLabs
Statera BioPharma, Inc. is an American clinical-stage biopharmaceutical company with a focus on novel immunotherapies. In 2021, Cleveland BioLabs merged with Cytocom, Inc, a clinical-stage biopharmaceutical company developing novel immunotherapies targeting autoimmune, inflammatory, infectious diseases, and cancers. The new company renamed itself "Statera BioPharma". Cleveland BioLabs Inc. had been founded in partnership with the Cleveland Clinic in 2003 and moved to the Buffalo Niagara Medical Campus in 2007.Dan Miner"Cleveland BioLabs' best shot" ''Buffalo Business First'', BizJournals, May 24, 2013, retrieved July 23, 2013. It had license agreements and collaborations with the Cleveland Clinic, Roswell Park Comprehensive Cancer Center, the Children's Cancer Institute Australia, and the Armed Forces Radiobiology Research Institute, and specialized in research and development of products with the potential to treat cancer and protect against death following acute radiation synd ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Animal Efficacy Rule
The Food and Drug Administration (United States), FDA animal efficacy rule (also known as animal rule) applies to Drug development, development and testing of drugs and biopharmaceutical, biologicals to reduce or prevent serious or life-threatening conditions caused by exposure to lethal or permanently disabling toxic agents (Chemical agent, chemical, Biological agent, biological, Radiological weapon, radiological, or nuclear substances), where human efficacy Clinical trial, trials are not feasible or Clinical research ethics, ethical. The animal efficacy rule was finalized by the FDA and authorized by the United States Congress in 2002, following the September 11 attacks and concerns regarding bioterrorism. Summary The FDA can rely on evidence from Animal testing, animal studies to provide substantial evidence of product effectiveness if: # There is a reasonably well-understood mechanism for the toxicity of the agent and its amelioration or prevention by the product; # The effect ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
TLR5
Toll-like receptor 5, also known as TLR5, is a protein which in humans is encoded by the ''TLR5'' gene. It is a member of the toll-like receptor (TLR) family. TLR5 is known to recognize bacterial flagellin from invading mobile bacteria. It has been shown to be involved in the onset of many diseases, which includes Inflammatory bowel disease. Recent studies have also shown that malfunctioning of TLR5 is likely related to rheumatoid arthritis, osteoclastogenesis, and bone loss. Abnormal TLR5 functioning is related to the onset of gastric, cervical, endometrial and ovarian cancers. Function The TLR family plays a fundamental role in pathogen recognition and activation of innate immunity. TLRs are highly conserved from Drosophila to humans and share structural and functional similarities. They recognize pathogen-associated molecular patterns (PAMPs) that are expressed on infectious agents, and mediate the production of cytokines necessary for the development of effective immunity. ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Hematopoietic
Haematopoiesis (, from Greek , 'blood' and 'to make'; also hematopoiesis in American English; sometimes also h(a)emopoiesis) is the formation of blood cellular components. All cellular blood components are derived from haematopoietic stem cells. In a healthy adult person, approximately – new blood cells are produced daily in order to maintain steady state levels in the peripheral circulation.Semester 4 medical lectures at Uppsala University 2008 by Leif Jansson Process Haematopoietic stem cells (HSCs) Haematopoietic stem cells (HSCs) reside in the medulla of the bone (bone marrow) and have the unique ability to give rise to all of the different mature blood cell types and tissues. HSCs are self-renewing cells: when they differentiate, at least some of their daughter cells remain as HSCs so the pool of stem cells is not depleted. This phenomenon is called asymmetric division. The other daughters of HSCs ( myeloid and lymphoid progenitor cells) can follow any of the other ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Gastrointestinal
The gastrointestinal tract (GI tract, digestive tract, alimentary canal) is the tract or passageway of the digestive system that leads from the mouth to the anus. The GI tract contains all the major organs of the digestive system, in humans and other animals, including the esophagus, stomach, and intestines. Food taken in through the mouth is digested to extract nutrients and absorb energy, and the waste expelled at the anus as feces. ''Gastrointestinal'' is an adjective meaning of or pertaining to the stomach and intestines. Most animals have a "through-gut" or complete digestive tract. Exceptions are more primitive ones: sponges have small pores ( ostia) throughout their body for digestion and a larger dorsal pore (osculum) for excretion, comb jellies have both a ventral mouth and dorsal anal pores, while cnidarians and acoels have a single pore for both digestion and excretion. The human gastrointestinal tract consists of the esophagus, stomach, and intestines, and is div ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
FDA Fast Track Development Program
Fast track is a designation by the United States Food and Drug Administration (FDA) of an investigational drug for expedited review to facilitate development of drugs that treat a serious or life-threatening condition and fill an unmet medical need. Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and attempt to make a decision within sixty days. Purpose Fast Track is one of five Food and Drug Administration (FDA) approaches to make new drugs available as rapidly as possible: the others are priority review, breakthrough therapy, accelerated approval and Regenerative Medicine Advanced Therapy. Fast Track was introduced by the FDA Modernization Act of 1997. Requirements Fast track designation is designed to aid in the development and expedite the review of drugs which show promise in treating a serious or life-threatening disease and address an unmet medical ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Department Of Health And Human Services
The United States Department of Health and Human Services (HHS) is a cabinet-level executive branch department of the U.S. federal government created to protect the health of all Americans and providing essential human services. Its motto is "Improving the health, safety, and well-being of America". Before the separate federal Department of Education was created in 1979, it was called the Department of Health, Education, and Welfare (HEW). HHS is administered by the Secretary of Health and Human Services, who is appointed by the president with the advice and consent of the United States Senate. The position is currently held by Xavier Becerra. The United States Public Health Service Commissioned Corps, the uniformed service of the PHS, is led by the Surgeon General who is responsible for addressing matters concerning public health as authorized by the secretary or by the assistant secretary for Health in addition to his or her primary mission of administering the Commissione ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
United States Department Of Defense
The United States Department of Defense (DoD, USDOD or DOD) is an executive branch department of the federal government charged with coordinating and supervising all agencies and functions of the government directly related to national security and the United States Armed Forces. The DoD is the largest employer in the world, with over 1.34 million active-duty service members (soldiers, marines, sailors, airmen, and guardians) as of June 2022. The DoD also maintains over 778,000 National Guard and reservists, and over 747,000 civilians bringing the total to over 2.87 million employees. Headquartered at the Pentagon in Arlington, Virginia, just outside Washington, D.C., the DoD's stated mission is to provide "the military forces needed to deter war and ensure our nation's security". The Department of Defense is headed by the secretary of defense, a cabinet-level head who reports directly to the president of the United States. Beneath the Department of Defense are th ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Emergency Use Authorization
An Emergency Use Authorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Act of Congress, Acts of Congress, including by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), as codified by , to allow the use of a drug prior to approved drug, approval. It does not constitute ''approval'' of the drug in the full statutory meaning of the term, but instead authorizes the FDA to facilitate availability of an unapproved product, or an unapproved use of an approved product, during a declared state of emergency from one of several agencies or of a "material threat" by the Secretary of Homeland Security. Use EUAs have historically been infrequent. A review article by Rizk et al. provides a summary of the US experience in 2020 with pharmacological EUA approvals during the COVID-19 pandemic. It also provides a descripti ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Cytotoxic Agents
Cytotoxicity is the quality of being toxic to cells. Examples of toxic agents are an immune cell or some types of venom, e.g. from the puff adder (''Bitis arietans'') or brown recluse spider (''Loxosceles reclusa''). Cell physiology Treating cells with the cytotoxic compound can result in a variety of cell fates. The cells may undergo necrosis, in which they lose membrane integrity and die rapidly as a result of cell lysis. The cells can stop actively growing and dividing (a decrease in cell viability), or the cells can activate a genetic program of controlled cell death ( apoptosis). Cells undergoing necrosis typically exhibit rapid swelling, lose membrane integrity, shut down metabolism, and release their contents into the environment. Cells that undergo rapid necrosis in vitro do not have sufficient time or energy to activate apoptotic machinery and will not express apoptotic markers. Apoptosis is characterized by well defined cytological and molecular events including a change ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Roswell Park Comprehensive Cancer Center
Roswell Park Comprehensive Cancer Center is a cancer research and treatment center located in Buffalo, New York. Founded by surgeon Roswell Park in 1898, the center was the first in the United States to specifically focus on cancer research. The center is usually called Roswell Park in short form. The center, which conducts clinical research on cancer as well as the development new drugs, provides advanced treatment for all forms of adult and pediatric cancer, and serves as a member of the National Comprehensive Cancer Network. Roswell Park Comprehensive Cancer Center is currently the only upstate New York facility to hold the National Cancer Institute designation of "comprehensive cancer center". The Roswell Park campus, spread out in 15 separate buildings of approximately two million square feet, occupies on the Buffalo Niagara Medical Campus (BNMC) in downtown Buffalo, and includes of space equally distributed between clinical programs and research/education functions. A sep ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
