Thallion Pharmaceuticals Inc. has announced that its intention to resume patient recruitment in its Phase II SHIGATEC study during October 2011, just before the upcoming high season for Shiga toxin-producing E. coli bacteria infections in South America.
On July 13, 2011, the Company announced that due to a preliminary product out-of-specification finding observed during routine stability testing of its anti-Stx1 monoclonal antibody, it decided to temporarily suspend screening and enrollment in the SHIGATEC study as a precautionary measure pending a more comprehensive assessment of the situation.
Over the course of the past several weeks, Thallion, in close collaboration with its development partner LFB Biotechnologies, has completed an in-depth analysis of the product OOS finding.
The results of this examination provide support for the continued use of the existing clinical product. The Company has nevertheless decided to wait for the results from one additional stability time point in early October before re-activating the study.
In parallel, the Company and LFB have committed to the manufacturing of a new lot of anti-Stx1 clinical material to provide further assurance for the timely completion of the trial. This new lot is expected to become available for use in the clinical study, if needed, in December.
"Whether the temporary suspension is lifted in October, as currently anticipated, or we elect to wait until the new lot of clinical material becomes available, we are confident that we will complete the SHIGATEC Phase II trial during this upcoming high season for STEC infections," said Dr. Allan Mandelzys, Thallion's Chief Executive Officer.
Dr. Mandelzys continued, "Accordingly, this temporary suspension should not adversely impact our overall clinical development timelines in a material way."