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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
Date:10/6/2009

nduct a Phase I/II clinical study of non-small cell lung cancer ("NSCLC") patients in parallel with a planned Phase I North American study in advanced solid tumor patients. Together, the two studies are expected to utilize open-label designs to evaluate the safety, tolerability and pharmacokinetic properties of multiple, ascending doses of L-DOS47 in tumor bearing patients. Helix anticipates the Polish study to additionally assess the prospective efficacy of L-DOS47 administration because of its focus on NSCLC patients. Helix also anticipates expanding the Polish study design to include arms in which patients will receive L-DOS47 administration together with leading chemotherapy or radiation therapy regimens. By doing so, Helix expects to broaden the likelihood of demonstrating efficacy in the study by additionally evaluating the envisioned chemo/radio-therapy potentiating properties of the DOS47 platform.

While the remaining clinic-enabling product development activities for L-DOS47 are progressing, Helix has continued to incur challenges in its manufacturing program which have in turn caused delays in the anticipated timing associated with filing its planned regulatory dossiers. After successfully completing production of GMP engineering batches of L-DOS47 earlier in the 2009 calendar year, the initial GMP clinical batch was rejected by the Company due to a deviation from the established manufacturing process, causing suspected contamination during fermentation. As a result, the Company has rescheduled production of its clinical batch, which has, in turn, caused program delays. Production of the required GMP clinical batch is now scheduled to be completed by the end of the Company's second quarter of fiscal 2010 to be followed by stability testing. Based on this, the Company now anticipates filing its U.S. Phase I and Polish Phase I/II regulatory dossiers by July 31, 2010, subject to timely and successful completion of the pre-IND filing requi
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