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     154  0 Kommentare Radius Announces First Patient Randomized in the RAD011 Pivotal Trial for Prader-Willi Syndrome - Seite 2


    Presenter: Dr. Anthony Goldstone (UK), co-Lead PI
  • [part of] Oral presentation (by-invitation only): a closed door KOLs meeting discussing all the studies a day prior to the main sessions
    Presenter: Dr. Deepan Singh (USA), study PI will talk about ‘all studies he’s part of’ including SCOUT-015
    • FPWR (Foundation for Prader-Willi Research)
      Place: Chicago, IL
      Dates: September 29-30

    About RAD011

    Investigational drug RAD011 is a pharmaceutical-grade synthetic cannabidiol oral solution, manufactured utilizing traditional pharmaceutical manufacturing processes. The product has purity specifications that meet standardized regulatory and quality control requirements and, compared to the process of developing a plant-derived product, the synthetic manufacturing process usually enables increased consistency and greater precision in the product supply. RAD011 has been assessed in over 125 patients across multiple indications and has potential utilization in multiple neuro-endocrine, neurodevelopmental, or neuropsychiatric disease areas. Radius has initiated a seamless pivotal Phase 2/3 study for patients with Prader-Willi Syndrome.

    About Radius
    Radius is a global biopharmaceutical company focused on addressing unmet medical needs in the areas of bone health, neuro-orphan diseases, and oncology. Radius’ lead product, TYMLOS (abaloparatide) injection, was approved by the U.S. Food and Drug Administration for the treatment of postmenopausal women with osteoporosis at high risk for fracture. The Radius clinical pipeline includes investigational abaloparatide injection for potential use in the treatment of men with osteoporosis; the investigational drug, elacestrant (RAD1901), for potential use in the treatment of hormone-receptor positive breast cancer out-licensed to Menarini Group; and the investigational drug RAD011, a synthetic cannabidiol oral solution with potential utilization in multiple neuro-endocrine, neurodevelopmental, or neuropsychiatric disease areas, initially targeting Prader-Willi Syndrome, Angelman syndrome, and infantile spasms.

    Forward-Looking Statements

    Lesen Sie auch

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the potential for RAD011 for the treatment of patients with PWS and ongoing clinical development activities with respect to RAD011.

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    Radius Announces First Patient Randomized in the RAD011 Pivotal Trial for Prader-Willi Syndrome - Seite 2 Advances asset in the neuro-endocrine orphan disease spaceSCOUT-015 clinical trial currently has 9 activated US sites and patient screening commenced30+ global sites are planned for the seamless Phase 2/3 pivotal trialPrimary endpoint of hyperphagia …

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