AURORA, Ontario, June 15 /PRNewswire/ -- Helix BioPharma Corp. ("Helix" or the "Company"), (TSX, FSE: "HBP") today announced its product development progress, quarterly highlights and financial results for the third quarter of fiscal 2009, ended April 30, 2009.
THIRD QUARTER HIGHLIGHTS AND PRODUCT DEVELOPMENT UPDATE
U.S. Registration Statement
Helix's 20-F registration statement filed with the U.S. Securities and Exchange Commission became effective during the quarter.
BioFinance 2009 Investor Conference Presentation
John Docherty, president and chief operating officer, presented at the BioFinance 2009 Investor Conference, where he provided an overview of the Company's leading technology platforms, DOS47(TM) and Biphasix(TM) and the Company's current product development programs, L-DOS47 and Topical Interferon Alpha-2b.
L-DOS47 Product Development Update
Over the past quarter, Helix has continued to advance towards initiating Phase I/II-level human clinical studies with L-DOS47. It has submitted a formal meeting request to the FDA for a pre-IND meeting, in anticipation of a future IND filing. The Company has also continued to advance its GMP manufacturing scale-up program with the successful production of engineering batches of L-DOS47, and is currently making preparations to produce its first clinical batch of GMP product to be used in its initial human trials.
Helix plans to file IND/CTA applications in North America and Europe, respectively, to seek permission to initiate Phase I/II studies. Due to recent challenges in successfully producing GMP engineering batches to date, including third party scheduling and technical issues, the Company has revised its estimated date of IND filing. Based on the estimated delay for completing the remaining program activities, and assuming successful and timely completi
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