Living Cell Technologies’ Accepts Proposed Revised Conditions for Diabetes Clinical Trial in New Zealand
News Jun 23, 2009
Living Cell Technologies Limited has announced the Company has accepted a preliminary decision from the New Zealand Minister of Health, the Honorable Tony Ryall, to issue a new conditional authorization for its New Zealand Phase I/IIa clinical trial of DIABECELL® for insulin dependent diabetes.
The Minister’s letter states that “the proposed condition that would require (LCT) to amend the inclusion criteria of (LCT’s) study to limit participation in the study to patients with brittle diabetes who suffer from significant metabolic instability is essential to ensure that the study complies with international guidelines, which require that participants obtain maximum benefit possible from their participation in the study”.
“The other proposed changes to the existing conditions are matters that LCT has agreed are appropriate during the peer review process, or are changes of a procedural, rather than a substantive nature ….”
The Company said that the clinical protocol for the New Zealand diabetes trial has already been amended according to the proposed new conditions from the Minister. LCT is pleased to have worked with the Ministry of Health to finalize the protocols for the clinical trial of DIABECELL®.
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