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Helix BioPharma Corp. Announces Fiscal 2009 Results
Date:10/29/2009

AURORA, Ontario, Oct. 29 /PRNewswire-FirstCall/ -- Helix BioPharma Corp. (TSX, FSE: HBP / OTCQX: HXBPF) today announced financial results for the year ended July 31, 2009.

During the 2009 fiscal year, the Company continued to make progress with its development initiatives for its lead drug candidates, L-DOS47 and Topical Interferon Alpha-2b. The following are selected highlights during the 2009 fiscal year and subsequent to year-end.

FISCAL 2009 HIGHLIGHTS

DOS47/L-DOS47

  • A pre-IND meeting with the U.S. Food and Drug Administration ("FDA") was held for L-DOS47 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 has been finalizing these plans with key opinion leader clinicians and contract research organizations in Poland. The study is expected to run concurrently with the U.S. Phase I trial 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.

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 FDA also confirmed Helix's expectation that an additional well-controlled, Phase III confirmatory clinical trial will be required to establish efficacy and safety of the product for marketing authorization purposes. Helix intends to continue to make preparations to conduct a European Phase III trial for this purpose.
  • The Phase II pharmacokinetic
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SOURCE Helix BioPharma Corp.
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