September 22, 2008
Helix Receives Approval to Open Sites in Germany for Its Ongoing Clinical Trial With Topical Interferon Alpha-2b in Patients With Ano-Genital Warts
AURORA, Ontario, Sept. 22 /PRNewswire/ -- Helix BioPharma announced today that it has received the necessary regulatory approvals to open clinical sites in Germany to expand upon its clinical trial with Topical Interferon Alpha-2b in patients with ano-genital warts, which is presently underway in Sweden.
"We are pleased to have received approval to open these additional clinical sites," said John Docherty, President of Helix BioPharma. "The opening of sites in Germany will grant us access to expanded clinical resources and a larger patient pool in order to enhance the recruitment rate of our trial."
The opening of additional sites in Germany is intended to compensate for a lower than expected patient enrollment rate thus far in Sweden. These sites have been added in order to speed the pace of enrollment to support Helix BioPharma's objective of completing patient enrollment by the end of the Company's fiscal fourth quarter, ending July 31, 2009.
About the Clinical Trial
The trial is designed to 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. 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.
Dr. Pal Wolner-Hanssen of the University hospital in Malmo MAS, Sweden will remain the overall coordinating investigator for the trial, and Professor Dr. med. Eggert Stockfleth of the Department of Dermatology, Skin Cancer Center Charite, Universitatsmedizin Berlin will oversee the German study activities specifically.
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. Each year in the United States alone, there are over 750,000 new cases of ano-genital warts.
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.
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".
For further information contact: Investor & Media Relations Ian Stone Russo Partners LLC Tel: (619) 814-3510 Fax: (619) 955-5318 Email: [email protected] David Schull Russo Partners LLC Tel: (212) 845-4271 Email: [email protected] http://www.russopartnersllc.com/
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 and information regarding the Company's Topical Interferon Alpha-2b and drug candidate L-DOS47 and the Company's research and development initiatives, which statements and information can be identified by the use of forward-looking terminology such as "to open", "intended", "in order to", "objective", "expected", "anticipates", or that events "will" occur, or comparable terminology referring to future events or results. Forward looking statements and information are statements and information 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 Topical Interferon Alpha-2b or L-DOS47 will be successfully developed and commercialized at all; uncertainty whether patient enrolment for the current clinical trial in Sweden will be completed by July 31, 2009 or at all; uncertainty whether the clinical trial will proceed or be completed as anticipated; the risk that the results of the clinical trial may be unsatisfactory resulting in the discontinued development of the drug; the need for additional studies and clinical trials, the occurrence and success of which cannot be assured; the risk that many new drugs fail in later studies and clinical trials; the risk of unexpected side effects; 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 and partnership/strategic alliance risks; the effect of competition; uncertainty of the size and existence of a market opportunity for Helix's products; 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 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 and information 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 or information should those beliefs, opinions or expectations, or other circumstances change.
Helix BioPharma Corp.
CONTACT: Investor & Media Relations: Ian Stone, +1-619-814-3510,+1-619-955-5318 (Fax), [email protected]; or David Schull,+1-212-845-4271, [email protected], both of Russo Partners LLCfor Helix BioPharma Corp.