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A Phase III Trial of NSI 566 in Patients with Amyotrophic Lateral Sclerosis (ALS)

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A Phase III Trial of NSI 566 in Patients with Amyotrophic Lateral Sclerosis (ALS)

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 28 Feb 2022

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At a glance

  • Drugs NSI 566 (Primary)
  • Indications Amyotrophic lateral sclerosis
  • Focus Therapeutic Use
  • Sponsors Palisade Bio; Seneca Biopharma

    • Most Recent Events

    • 09 Apr 2020 According to a Seneca Biopharma media release, the company received significant guidance from FDA regarding an acceptable trial design and is in the process of developing the protocol for further review.The company looks forward to working closely with the Agency on finalizing the design of this Phase 3 trial for the devastating disease.
    • 09 Apr 2020 According to a Seneca Biopharma media release, as a result of the discussion and feedback received from the FDA, Seneca believes that the existing phase 1 and 2 trial results support moving into this phase 3 clinical study for ALS.
    • 09 Apr 2020 According to a Seneca Biopharma media release, the company held a Type C meeting with the Office of Tissues and Advanced Therapies at the FDA on 10th Mar 2020 to discuss future clinical development plans for NSI-566, for the treatment of patients with amyotrophic lateral sclerosis (ALS).

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