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Helix BioPharma Provides Updates on Topical Interferon Alpha-2b and L-DOS47 Following Pre-IND Meetings With the U.S. FDA
Helix BioPharma Provides Updates on Topical Interferon Alpha-2b and L-DOS47 Following Pre-IND Mee...
About this update from Helix Biopharma Corp.
[{"type":"text","content":"\n\n\n\nOct. 6, 2009 (Canada NewsWire Group) -- AURORA, Ontario, Oct. 6 /CNW/ -- Helix requested the pre-IND meetings in order to confirm its plans for future investigational new drug (\"IND\") filings with the FDA. The meeting on Topical Interferon Alpha-2b was designed to confirm the data requirements needed, beyond the completed Phase II cervical dysplasia study to proceed to Phase II/III clinical testing in the U.S. for this indication. The pre-IND meeting on L-DOS47 was designed to receive guidance from the FDA on requirements that must be met by Helix before requesting approval to begin a Phase I study in the U.S.AURORA, Ontario, Oct. 6 /CNW/ -- As expected, Helix must first demonstrate that there is no significant systemic interferon alpha-2b exposure in the open-label Phase II pharmacokinetic study before filing a U.S. Phase II/III IND. This study is currently underway in Germany. The pharmacokinetic trial will enroll up to 28 patients in order to obtain a minimum of 12 patients for evaluation for the primary study endpoint. Helix plans to proceed with filing its Phase II/III IND if sufficient positive data are obtained from the first 12 patients completing the study, and all other study findings are positive. If required, Helix may expand the data set beyond the first 12 patients if the results indicate more data are needed. Preliminary findings from patients enrolled so far in this study show no significant systemic interferon alpha-2b exposure. While the study is progressing, enrollment to date has been slower than previously anticipated. Given the recruiting challenges to date, the Company has revised its timeline for the pharmacokinetic study. In order to enhance the patient recruitment rate, the Company intends to open additional clinical sites during the Company's second quarter of fiscal 2010. Assuming the patient recruitment rate improves as planned, Helix now expects it will take until the end of its third quarter of fiscal 2010 for the 12 minimum required patients to complete the study, and up to the end of its first quarter of fiscal 2011 for all 28 patients to do so.AURORA, Ontario, Oct. 6 /CNW/ -- Given the anticipated timeline for the pharmacokinetic study activities, and assuming successful completion of the scale-up GMP engineering batch manufacturing, Helix now projects that its U.S. Phase II/III IND fi...