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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

AURORA, Ontario, Oct. 6 /PRNewswire-FirstCall/ -- Helix BioPharma Corp. (TSX, FSE: HBP / OTCQX: HXBPF) today announced progress updates for its ongoing Topical Interferon Alpha-2b and L-DOS47 product development programs following pre-investigational new drug ("pre-IND") meetings with the U.S. Food and Drug Administration ("FDA").

Helix requested the pre-IND meetings in order to confirm its plans for future investigational new drug ("IND") filings with the FDA. The meeting on Topical Interferon Alpha-2b was designed to confirm the data requirements needed, beyond the completed Phase II cervical dysplasia study to proceed to Phase II/III clinical testing in the U.S. for this indication. The pre-IND meeting on L-DOS47 was designed to receive guidance from the FDA on requirements that must be met by Helix before requesting approval to begin a Phase I study in the U.S.

"We are very pleased with the outcomes of both pre-IND meetings with the FDA," said John Docherty, president and chief operating officer of Helix BioPharma. "Our discussions confirmed our expectations of what is necessary to proceed with both clinical programs and we now have a clearly identified path to progress to those clinical investigations."

Topical Interferon Alpha-2b - Cervical Dysplasia Indication

The pre-IND meeting with the FDA was held to confirm the specific regulatory requirements for commencing U.S. clinical testing of its Topical Interferon Alpha-2b in patients with cervical dysplasia. Based on this meeting, a U.S. Phase II/III, randomized, vehicle-controlled clinical trial will be acceptable as the next clinical trial in Helix's Topical Interferon alpha-2b clinical development program.

As expected, Helix must first demonstrate that there is no significant systemic interferon alpha-2b exposure in the open-label Phase II pharmacokinetic study before filing a U.S. Phase II/III IND. This study is currently underway i
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SOURCE Helix BioPharma Corp.
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