Published online before print August 23, 2007, doi: 10.1161/STROKEAHA.107.493411
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(Stroke. 2007;38:e110.)
© 2007 American Heart Association, Inc.
Letters to the Editor |
Response to Letter by Proctor and Tamborello
University Department of Medicine & Therapeutics, Gardiner Institute, Western Infirmary, Glasgow, UK
AstraZeneca R&D, Medical Neuroscience, Södertälje, Sweden
Vice President, Global Product Director NXY-059, AstraZeneca R&D, Södertälje, Sweden
Response
It is premature to comment on SAINT II before any manuscript is published. However, the suggestion that different products were used for the 2 SAINT trials can be discounted. Relevant knowledge contained in the patent application was applied identically to the study drug supplied for SAINT I and II. The patent application for test article preparation was filed in Sweden in May 2000 and filed internationally in May 2001. SAINT I commenced in April 2003. The suggestion that the SAINT I trial may have been delayed pending animal toxicity tests is also untrue. Appropriate testing was completed before early phase trials. The SAINT I protocol was finalized in December 2002, after the last of the preclinical efficacy studies advised by STAIR guidelines had concluded.1,2 Recruitment to SAINT I started promptly after Institutional Review Board and regulatory approvals, in April 2003, and completed ahead of schedule.3,4 Recruitment into SAINT II was impaired for a while in the US because of an interim restriction on the protocol barring concomitant treatment with rt-PA pending completion of the FDA requested interaction data.
Acknowledgments
Disclosures
K.R.L. received fees, expenses, and institutional investigator fees for steering committee work and trial participation from AstraZeneca. T.A. and T.O. are employees of AstraZeneca.
References
1. Stroke Therapy Academic Industry Roundtable. Recommendations for standards regarding preclinical neuroprotective and restorative drug development. Stroke. 1999; 30: 2752–2758.
2. Marshall JWB, Cummings RM, Bowes LJ, Ridley RM, Green AR. Functional and histological evidence for the protective effect of NXY-059 in a primate model of stroke when given 4 hours after occlusion. Stroke. 2003; 34: 2228–2233.
3. Lees KR, Zivin JA, Ashwood T, Davalos A, Davis SM, Diener HC, Grotta J, Lyden P, Shuaib A, Hardemark HG, Wasiewski WW; Stroke-Acute Ischemic NXY Treatment (SAINT I) Trial Investigators. NXY-057 for acute ischemic stroke. N Eng J Med. 2006; 354: 588–600.
4. Lees KR, Davalos A, Davis SM, Diener H-C, Grotta J, Lyden P, Shuaib A, Ashwood T, Hardemark HG, Wasiewski W, Emeribe U, Zivin JA; for the SAINT I Investigators. Additional Outcomes and Subgroup Analyses of NXY-059 for Acute Ischemic Stroke in the SAINT I Trial. Stroke. 2006; 37: 2970–2978.
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