Helix BioPharma Corp. (TSX, FSE: "HBP" / OTCQX: HXBPF) today announced results from the Phase II clinical trial assessing the efficacy and safety of Topical Interferon Alpha-2b cream for the treatment of ano-genital warts (AGW).
Analysis of the primary study endpoint, that is, the proportion of patients with complete clearance of their baseline lesions during the eight week treatment period, as well as the secondary efficacy endpoints, showed no statistically significant treatment effects between the treatment and the placebo groups. Topical Interferon Alpha-2b was very well tolerated. Local skin reactions (e.g., itching, burning or pain) in both groups were mostly absent or mild, and there were no treatment-related serious adverse events, which is consistent with previous clinical findings with Topical Interferon Alpha-2b.
"We remain focused on our lead indication, the treatment of women with low grade cervical lesions, based on our previously announced positive Phase II study results for this indication," said John Docherty, president and COO of Helix BioPharma. "Despite the lack of efficacy shown for the AGW indication, we are pleased with this trial's tolerability results which strengthen our safety database for future clinical testing. We are on track to file our IND for our planned Phase II/III trial in the U.S. for our lead indication in or around the end of fiscal 2010, subject to successful completion of our remaining IND-enabling activities as previously reported. We will be considering the results of the AGW study in detail to determine our next steps forward for this indication, if applicable."