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CytoDyn Advised of Protocol Deviation in Bird Flu Vaccine Study

Posted on: Tuesday, 10 July 2007, 09:23 CDT

CytoDyn, Inc. (Pink Sheets:CYDY), as the study sponsor, has been advised of a protocol deviation that occurred in a murine study of dosing and immunogenicity for DNA-based bird flu vaccines. The purpose of the study is to provide empirical validation of the Company's design for a clinical trial, or to identify any needed modifications to the clinical trial design. CytoDyn's clinical trial is intended as a preliminary demonstration of safety and efficacy (through the standard marker of protective antibodies) both for the Company's family of DNA flu vaccines, and for a proprietary method of using such vaccines.

The 42-week study (NAWI1618-07-01) uses 10 groups of BALB/C mice, with four mice in each group for a total of 40 mice. The four mice in Group 6 were inadvertently boosted with the wrong DNA plasmid on July 3, 2007, the 40th week of the study. What effect, if any, this will have in the context of the study will not be known until the terminal bleed on July 17, 2007, because the study is blinded.

CytoDyn CEO, Allen D. Allen, points out that, ironically, this type of deviation has been known to reveal important new phenomena which scientists would not otherwise see because the phenomena could not have been anticipated. On the other hand, omitting blood samples that were collected from 10% of the mice after the 40th week of the study is more likely to be insignificant across the 42-week study, according to Allen.

This press release contains forward-looking statements that are not historical facts. The Company's management makes forward-looking statements concerning the Company's expected future operations, performance and other developments. These forward-looking statements are necessarily estimates based upon current information and involve a number of risks and uncertainties. There can be no assurance that such risks and uncertainties, or other factors, will not affect the accuracy of such forward-looking statements. It is impossible to identify all factors that could cause actual results to differ materially from those estimated by the Company. They include, but are not limited to, government regulation, managing and maintaining growth, victimization by white-collar offenders, and the effects of adverse publicity, litigation, competition, and other factors that may be identified from time to time in the Company's announcements.

Source: Business Wire

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