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 /CNW/ -- 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
    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: ian.stone@russopartnersllc.com

           David Schull
           Russo Partners LLC
           Tel: (212) 845-4271
           Email: david.schull@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.

For further information:

For further information: Investor & Media Relations: Ian Stone,
+1-619-814-3510, +1-619-955-5318 (Fax), ian.stone@russopartnersllc.com; or
David Schull, +1-212-845-4271, david.schull@russopartnersllc.com, both of
Russo Partners LLC for Helix BioPharma Corp.

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