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Helix BioPharma Announces Q3 2009 Financial Results and Provides Product Development Update
AURORA, Ontario, June 15 /CNW/ -- Helix BioPharma Corp. ("Helix" or the "Company"), (TSX, FSE: "H...
About this update from Helix Biopharma Corp.
[{"type":"text","content":"\n\n\n\nAURORA, Ontario, June 15 /CNW/ -- Helix BioPharma Corp. ("Helix" or the\n"Company"), (TSX, FSE: "HBP") today announced its product development\nprogress, quarterly highlights and financial results for the third quarter of\nfiscal 2009, ended April 30, 2009.\n\n\n\nTHIRD QUARTER HIGHLIGHTS AND PRODUCT DEVELOPMENT UPDATE\n\nU.S. Registration Statement\n\n\nHelix's 20-F registration statement filed with the U.S. Securities and\nExchange Commission became effective during the quarter.\n\n\n\nBioFinance 2009 Investor Conference Presentation\n\n\nJohn Docherty, president and chief operating officer, presented at the\nBioFinance 2009 Investor Conference, where he provided an overview of the\nCompany's leading technology platforms, DOS47(TM) and Biphasix(TM) and the\nCompany's current product development programs, L-DOS47 and Topical Interferon\nAlpha-2b.\n\n\n\nL-DOS47 Product Development Update\n\n\nOver the past quarter, Helix has continued to advance towards initiating\nPhase I/II-level human clinical studies with L-DOS47. It has submitted a\nformal meeting request to the FDA for a pre-IND meeting, in anticipation of a\nfuture IND filing. The Company has also continued to advance its GMP\nmanufacturing scale-up program with the successful production of engineering\nbatches of L-DOS47, and is currently making preparations to produce its first\nclinical batch of GMP product to be used in its initial human trials.\n\n\nHelix plans to file IND/CTA applications in North America and Europe,\nrespectively, to seek permission to initiate Phase I/II studies. Due to\nrecent challenges in successfully producing GMP engineering batches to date,\nincluding third party scheduling and technical issues, the Company has revised\nits estimated date of IND filing. Based on the estimated delay for completing\nthe remaining program activities, and assuming successful and timely\ncompletion of such activities, the Company now expects its IND filing to occur\nwithin approximately six months of the previously anticipated date of July 31,\n2009. The success of upcoming program efforts, including the remaining GMP\nscale-up production activities, the outcome of its upcoming pre-IND meeting\nand the outcome of the remaining non-clinical pharmacology and toxicology\nstudies will ultimately determine the timing of Helix's P...