Business
Helix BioPharma Corp. initiates enrollment in Phase II clinical trial with Topical Interferon Alpha-2b in patients with ano-genital warts
Helix BioPharma Corp. initiates enrollment in Phase II clinical trial with Topical Interferon Alpha-2b in patients with ano-genital warts.
About this update from Helix Biopharma Corp.
[{"type":"text","content":"\n\n\n\nAURORA, ON, Dec. 11 /CNW/ - Helix BioPharma Corp. (TSX, FSE: \"HBP\")\nannounced today that it has initiated patient enrollment in a Phase II\nclinical trial of Topical Interferon Alpha-2b for the treatment of ano-genital\nwarts (condylomata accuminata) associated with human papilloma virus (\"HPV\")\ninfection.\n\n\nThe trial, which is taking place in Sweden, will assess the efficacy and\nsafety of Topical Interferon Alpha-2b compared with placebo using a double\nblind, randomized design over an examination period of four months per\npatient. One hundred twenty patients are to be enrolled in the trial. Half\nwill receive a placebo and half will receive Topical Interferon Alpha-2b\nreceiving group. Only female subjects are to be enrolled in the trial in order\nto avoid inter-sex treatment variations.\n\n\nTrial subjects will self-administer Topical Interferon Alpha-2b twice\ndaily for five consecutive days per week over a treatment period of eight\nweeks, with a follow-up visit at 16 weeks. The primary endpoint for the trial\nwill be comparison of the proportion of patients with complete clearance of\ntheir baseline lesions during the eight week treatment period.\n\n\n\"We are very pleased to be commencing patient enrollment in this trial,\nafter months of preparations and having recently raised additional capital to\nhelp support our development program initiatives,\" said John Docherty, Vice\nPresident of Corporate Development for Helix BioPharma Corp. \"Ano-genital\nwarts represent the second major target indication to be sought for our\nTopical Interferon Alpha-2b, to hopefully build upon its broad utility as a\ntopical treatment for HPV-induced skin/mucosal lesions.\"\n\n\nThe trial is being conducted across multiple centers in Sweden under the\ndirection of Dr. Pal Wolner-Hanssen, the coordinating investigator at the\nUniversity hospital in Malmo MAS. Helix has contracted the services of\nEncorium Group Inc., a multi-national, full-service contract research\norganization with local offices in Sweden, to assist Helix in managing the\nconduct and evaluation of the trial.\n\n\nAbout Ano-Genital Warts\n\n\nAno-genital warts result from HPV infection of the external genitalia,\nand can manifest as outwardly visible growths of varying sizes and shapes in\nboth men and women. The U.S. Centers for Disease Control and Preve...