AURORA, ON, Dec. 11 /PRNewswire-FirstCall/ - Helix BioPharma Corp. announced today that it has initiated patient enrollment in a Phase II clinical trial of Topical Interferon Alpha-2b for the treatment of ano-genital warts (condylomata accuminata) associated with human papilloma virus ("HPV") infection.
The trial, which is taking place in Sweden, will assess the efficacy and safety of Topical Interferon Alpha-2b compared with placebo using a double blind, randomized design over an examination period of four months per patient. One hundred twenty patients are to be enrolled in the trial. Half will receive a placebo and half will receive Topical Interferon Alpha-2b receiving group. Only female subjects are to be enrolled in the trial in order to avoid inter-sex treatment variations.
Trial subjects will self-administer Topical Interferon Alpha-2b twice daily for five consecutive days per week over a treatment period of eight weeks, with a follow-up visit at 16 weeks. The primary endpoint for the trial will be comparison of the proportion of patients with complete clearance of their baseline lesions during the eight week treatment period.
"We are very pleased to be commencing patient enrollment in this trial, after months of preparations and having recently raised additional capital to help support our development program initiatives," said John Docherty, Vice President of Corporate Development for Helix BioPharma Corp. "Ano-genital warts represent the second major target indication to be sought for our Topical Interferon Alpha-2b, to hopefully build upon its broad utility as a topical treatment for HPV-induced skin/mucosal lesions."
The trial is being conducted across multiple centers in Sweden under the direction of Dr. Pal Wolner-Hanssen, the coordinating investigator at the University hospital in Malmo MAS. Helix has contracted the services of Encorium Group Inc., a multi-national, full-service contract research organization with local offices in Sweden, to assist Helix in managing the conduct and evaluation of the trial.
About Ano-Genital Warts
Ano-genital warts result from HPV infection of the external genitalia, and can manifest as outwardly visible growths of varying sizes and shapes in both men and women. The U.S. Centers for Disease Control and Prevention ("CDC") estimates that more than 1.4 million people develop ano-genital warts each year in the US alone.
About Topical Interferon Alpha-2b
Interferon Alpha-2b is an immune system modulator that is active against a variety of HPV-induced lesions. Interferon Alpha-2b is thought to function by triggering an antiviral response within infected cells, by activating certain intracellular enzymes which cause degradation of viral RNA, and by mobilizing the body's natural immune system to destroy the infected cells. Interferon Alpha-2b has been widely used commercially as a treatment for ano-genital warts caused by HPV, but is not generally favoured due to the fact that conventional administration requires painful intradermal injection by a medical professional. Furthermore, intradermal injection is restricted to visible lesion administration, while HPV infection is often characterized by both visible and non-visible (i.e. sub-clinical) lesions.
Helix's Topical Interferon Alpha-2b is expected to offer a safe, discreet, self-administered, pain-free therapy that can be broadly applied across the entire affected tissue area. Helix anticipates that this will prove highly advantageous not only from a patient compliance perspective, but also from an efficacy standpoint, by offering a new means of targeting both visible and sub-clinical lesions and treating cervical infection that was previously impractical to treat via injection.
About Helix BioPharma Corp.
Helix BioPharma Corp. is a biopharmaceutical company specializing in the field of cancer therapy. The Company is actively developing innovative products for the prevention and treatment of cancer based on its proprietary technologies. Helix's product development initiatives include its Topical Interferon Alpha-2b and its novel L-DOS47 new drug candidate. Helix is listed on the TSX under the symbol "HBP".
The Toronto and Frankfurt Stock Exchanges have not reviewed and do not accept responsibility for the adequacy or accuracy of the content of this News Release. This News Release contains certain forward-looking statements regarding the Company's Topical Interferon Alpha-2b and the Company's research and development initiatives, which statements can be identified by the use of forward-looking terminology such as "to be", "hopefully", "expected", "anticipated", or that events "will" occur, or comparable terminology referring to future events or results. Forward looking statements are statements about the future and are inherently uncertain, and Helix's actual results could differ materially from those anticipated in these forward-looking statements as a result of numerous factors, including without limitation, uncertainty whether the clinical trial will be completed as planned or at all; uncertainty whether the clinical trial will achieve expected results and the possibility that such results may be negative; the need for additional clinical trials, the occurrence and success of which cannot be assured; product liability and insurance risks; research & development risks, the risk of technical obsolescence; the need for further regulatory approvals, which may not be obtained in a timely matter or at all; intellectual property risks; marketing/manufacturing (including scale-up) risks; partnership/strategic alliance risks; the effect of competition; uncertainty of the size and existence of a market opportunity for Helix's products; uncertainty as to whether the Company's products will be successfully commercialized, or at all; Helix's need for additional future capital, which may not be available in a timely manner or at all; as well as a description of other risks and uncertainties affecting Helix and its business, as contained in the Company's latest Annual Information Form and other filings with the Canadian Securities Regulatory Authorities, any of which could cause actual results to vary materially from current results or Helix's anticipated future results. Forward-looking statements are based on the beliefs, opinions and expectations of Helix's management at the time they are made, and Helix does not assume any obligation to update any forward-looking statement should those beliefs, opinions or expectations, or other circumstances change.
Helix BioPharma Corp.CONTACT: Investor Relations: Christina Bessant or Nick Hurst, The EquicomGroup, Tel: (416) 815-0700 ext. 269, (800) 385-5451, Fax: (416) 815-0080,Email: cbessant@equicomgroup.com, nhurst@equicomgroup.com; Media Relations:Matthew Haines, Noonan Russo, Tel: (212) 845-4235, Fax: (212) 845-4260,Email: Matthew.Haines@eurorscg.com, www.NoonanRusso.com
