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Clinical Trials Insight: 700020515

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Trial Profile

Clinical Trials Insight: 700020515

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Mar 2010

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At a glance

  • Drugs Sitimagene ceradenovec (Primary) ; Temozolomide
  • Indications Glioma
  • Focus Registrational; Therapeutic Use
  • Sponsors Ark Therapeutics

Most Recent Events

  • 09 Mar 2010 Ark Therapeutics has withdrawn its MAA, according to a company media release. The EMEA's Scientific Advisory Group on Oncology re-examined the filing and concluded that this trial did not provide sufficient evidence of a clincial benefit.
  • 21 Dec 2009 The EMEA's CHMP adopted a negative opinion regarding the MAA, according to an Ark media release. The Committee's negative opinion was based on possible differences between groups in treatment delays, which could have affected the primary endpoint.
  • 14 Oct 2009 Results will be presented at the American Society of Neuro-Oncology Conference in New Orleans on 22 October 2009, according to an Ark Therapeutics media release.

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