Prasinezumab
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Prasinezumab
Prasinezumab (, ; developmental code names NEOD002, PRX-002, RG-7935, RO-7046015) is an anti-α-synuclein drug acting as a monoclonal antibody against α-synuclein which is under development for the treatment of Parkinson's disease. No significant effect on disease progression was seen in a 52-week phase 2 clinical trial.There have been concerns about research misconduct and data fabrication relevant to prasinezumab. As of May 2024, prasinezumab is in phase 3 clinical trials for Parkinson's disease. It is under development by Prothena Biosciences and Roche. Mechanism of action Prasinezumab is a humanized IgG1 monoclonal antibody that selectively binds to aggregated forms of alpha-synuclein while sparing the physiological monomeric form. The antibody recognizes the C-terminus of α-synuclein and preferentially targets pathological aggregates that form insoluble fibrils and Lewy bodies—hallmark features of Parkinson's disease pathology. Development history Prasinezumab was or ...
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Research Misconduct
Scientific misconduct is the violation of the standard codes of scholarly conduct and ethical behavior in the publication of professional scientific research. It is the violation of scientific integrity: violation of the scientific method and of research ethics in science, including in the design, conduct, and reporting of research. A '' Lancet'' review on ''Handling of Scientific Misconduct in Scandinavian countries'' provides the following sample definitions, reproduced in The COPE report 1999: * Danish definition: "Intention or gross negligence leading to fabrication of the scientific message or a false credit or emphasis given to a scientist" * Swedish definition: "Intention ldistortion of the research process by fabrication of data, text, hypothesis, or methods from another researcher's manuscript form or publication; or distortion of the research process in other ways." The consequences of scientific misconduct can be damaging for perpetrators and journal audiences an ...
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Anti-α-synuclein Drug
An anti-α-synuclein drug, or an α-synuclein inhibitor, is a drug which blocks or inhibits α-synuclein. α-Synuclein is a protein which is thought to be involved in the development and progression of α-synucleinopathies including Parkinson's disease, dementia with Lewy bodies, and multiple system atrophy. Anti-α-synuclein drugs are under development for treatment of Parkinson's disease and other α-synuclein-related diseases. Examples include the monoclonal antibodies prasinezumab and cinpanemab, which both failed to show effectiveness in slowing the progression of Parkinson's disease in phase 2 clinical trials. Other anti-α-synuclein drugs, like the monoclonal antibody exidavnemab, the α-synuclein vaccines PD01A and PD03A, and the small-molecule α-synuclein misfolding and aggregation inhibitors minzasolmin and emrusolmin, are also under development. Memantine is also being studied as a potential disease-modifying treatment for Parkinson's disease by inhibiting cell-t ...
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Data Fabrication
In scientific inquiry and academic research, data fabrication is the intentional misrepresentation of research results. As with other forms of scientific misconduct, it is the intent to deceive that marks fabrication as unethical, and thus different from scientists deceiving themselves. There are many ways data can be fabricated. Experimental data can be fabricated by reporting experiments that were never conducted, and accurate data can be manipulated or misrepresented to suit a desired outcome. One of the biggest problems with this form of scientific fraud is that "university investigations into research misconduct are often inadequate, opaque and poorly conducted. They challenge the idea that institutions can police themselves on research integrity." Sometimes intentional fabrication can be difficult to distinguish from unintentional academic incompetence or malpractice. Examples of this include the failure to account for measurement error, or the failure to adequately control ...
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Monoclonal Antibodies
A monoclonal antibody (mAb, more rarely called moAb) is an antibody produced from a Lineage (evolution), cell lineage made by cloning a unique white blood cell. All subsequent antibodies derived this way trace back to a unique parent cell. Monoclonal antibodies are identical and can thus have Valence (chemistry), monovalent affinity, binding only to a particular epitope (the part of an antigen that is recognized by the antibody). In contrast, polyclonal antibodies are mixtures of antibodies derived from multiple plasma cell lineages which each bind to their particular target epitope. Artificial antibodies known as bispecific monoclonal antibodies can also be engineered which include two different antigen binding sites (Fragment antigen-binding region, FABs) on the same antibody. It is possible to produce monoclonal antibodies that specifically bind to almost any suitable substance; they can then serve to detect or purify it. This capability has become an investigative tool in b ...
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Experimental Monoclonal Antibodies
An experiment is a procedure carried out to support or refute a hypothesis, or determine the efficacy or likelihood of something previously untried. Experiments provide insight into cause-and-effect by demonstrating what outcome occurs when a particular factor is manipulated. Experiments vary greatly in goal and scale but always rely on repeatable procedure and logical analysis of the results. There also exist natural experimental studies. A child may carry out basic experiments to understand how things fall to the ground, while teams of scientists may take years of systematic investigation to advance their understanding of a phenomenon. Experiments and other types of hands-on activities are very important to student learning in the science classroom. Experiments can raise test scores and help a student become more engaged and interested in the material they are learning, especially when used over time. Experiments can vary from personal and informal natural comparisons ( ...
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Cinpanemab
Cinpanemab (, ; developmental code names BIIB054, NI-202) is an anti-α-synuclein drug acting as a monoclonal antibody against α-synuclein which was under development for the treatment of Parkinson's disease. It showed no significant influence on disease progression in a 52-week phase 2 clinical trial. The drug reached phase 2 clinical trials but was discontinued in 2021 due its lack of effectiveness. It was under development by Biogen. See also * Prasinezumab Prasinezumab (, ; developmental code names NEOD002, PRX-002, RG-7935, RO-7046015) is an anti-α-synuclein drug acting as a monoclonal antibody against α-synuclein which is under development for the treatment of Parkinson's disease. No signifi ... References External links Cinpanemab - AlzForum {{Monoclonals for bone, musculoskeletal, circulatory, and neurologic systems Experimental drugs Experimental monoclonal antibodies Parkinson's disease ...
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Hoffmann-La Roche
F. Hoffmann-La Roche AG, commonly known as Roche (), is a Swiss multinational holding healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has shares listed on the SIX Swiss Exchange. The company headquarters are located in Basel. Roche is the fifth-largest pharmaceutical company in the world by revenue and the leading provider of cancer treatments globally. In 2023, the company’s seat in Forbes Global 2000 was 76. The company owns the American biotechnology company Genentech, which is a wholly owned independent subsidiary, and the Japanese biotechnology company Chugai Pharmaceuticals, as well as the United States–based companies Ventana and Foundation Medicine. Roche's revenues during fiscal year 2020, were 58.32 billion Swiss francs. Descendants of the founding Hoffmann and Oeri families own slightly over half of the bearer shares with voting rights (a pool of family shareholders 45%, ...
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Lewy Bodies
Lewy bodies are the inclusion bodies â€“ abnormal aggregations of protein â€“ that develop inside neurons affected by Parkinson's disease (PD), the Lewy body dementias (Parkinson's disease dementia and dementia with Lewy bodies (DLB)), and some other disorders. They are also seen in cases of multiple system atrophy, particularly the parkinsonian variant (MSA-P). Lewy bodies appear as spherical masses in the cytoplasm that displace other cell components. For instance, some Lewy bodies tend to displace the nucleus to one side of the cell. There are two main kinds of Lewy bodies â€“ classical and cortical. A classical Lewy body is an eosinophilic cytoplasmic inclusion consisting of a dense core surrounded by a halo of 10 nm wide radiating fibrils, the primary structural component of which is alpha-synuclein (α-synuclein). While similar in many other respects, cortical Lewy bodies are only faintly eosinophilic, do not have a surrounding halo, and do not show a radia ...
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α-Synuclein
Alpha-synuclein (aSyn) is a protein that in humans is encoded by the ''SNCA'' gene. It is a neuronal protein involved in the regulation of synaptic vesicle trafficking and the release of neurotransmitters. Alpha-synuclein is abundant in the brain, with smaller amounts present in the heart, muscles, and other tissues. Within the brain, it is primarily localized to the axon terminals of presynaptic neurons. There, it interacts with phospholipids and other proteins. Presynaptic terminals release neurotransmitters from specialized compartments called synaptic vesicles, a process essential for neuronal communication and normal brain function. In Parkinson's disease and related synucleinopathies, abnormal, insoluble forms of alpha-synuclein accumulate within neurons as inclusions known as Lewy bodies. Mutations in the ''SNCA'' gene are linked to familial forms of Parkinson's disease. During the process of seeded nucleation, alpha-synuclein adopts a cross-beta sheet structure charac ...
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Intravenous Therapy
Intravenous therapy (abbreviated as IV therapy) is a medical technique that administers fluids, medications and nutrients directly into a person's vein. The intravenous route of administration is commonly used for rehydration or to provide nutrients for those who cannot, or will not—due to reduced mental states or otherwise—consume food or water per os, by mouth. It may also be used to administer pharmaceutical drug, medications or other medical therapy such as blood transfusion, blood products or electrolytes to correct electrolyte imbalances. Attempts at providing intravenous therapy have been recorded as early as the 1400s, but the practice did not become widespread until the 1900s after the development of techniques for safe, effective use. The intravenous route is the fastest way to deliver medications and fluid replacement throughout the body as they are introduced directly into the circulatory system and thus quickly distributed. For this reason, the intravenous route ...
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Clinical Trial
Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, pharmaceutical drug, drugs, medical nutrition therapy, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received institutional review board, health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted. Depending on product type and development stage, investigators initially enroll volunteers or patients into small Pilot experiment, pi ...
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