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Helix BioPharma Corp. Announces Fiscal Q1 2010 Results
Date:12/9/2009

AURORA, Ontario, Dec. 9 /PRNewswire-FirstCall/ -- Helix BioPharma Corp. (TSX, FSE: HBP; OTCQX: HXBPF) today announced financial results for the first quarter ended October 31, 2009.

FIRST QUARTER 2010 HIGHLIGHTS

DOS47/L-DOS47

  • Helix announced that a pre-IND meeting had been held for L-DOS47 with the U.S. Food and Drug Administration ("FDA") in which the FDA generally agreed with Helix's proposed remaining non-clinical pharmacology and toxicology studies as well as its remaining GMP manufacturing program initiatives prior to IND filing.
  • Helix announced plans to conduct a Phase I/II clinical study of non-small cell lung cancer ("NSCLC") patients in Poland. Helix continues to develop these plans together with key opinion leader clinicians and prospective contract research organizations. The study is expected to run concurrently with the U.S. Phase I study in refractory solid tumor patients. The timing of both studies will be contingent on the timing of regulatory approvals of the trials as well as obtaining additional capital. The Company continues to plan to file an investigational new drug submission ("IND") and clinical trial application ("CTA") in its fourth quarter of fiscal 2010, pending timely and successful completion of the Company's planned remaining pre-IND activities.

Topical Interferon Alpha-2b

  • A pre-IND meeting with the FDA was held in which the FDA confirmed the acceptability of a Phase II/III, randomized, vehicle-controlled clinical trial as the next step in the compound's clinical development plan for patients with cervical dysplasia. The Company continues to project that its U.S. Phase II/III IND filing will occur, at the earliest, in its fourth quarter of fiscal 2010, pending timely and successful completion of its remaining pre-IND activities. The FDA also confirmed Helix's expectation that an additional well-controlled, Phase III confirm
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