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Helix Biopharma Corp.
Helix opens additional sites for its Topical Interferon Alpha-2b Phase II clinical study
Published Jun 2 2005
4 min read

Helix opens additional sites for its Topical Interferon Alpha-2b Phase II clinical study

AURORA, ON, June 2 /CNW/ - Helix BioPharma announced today the opening of
two additional German sites for the Phase II clinical trial of its Topical
Interferon Alpha-2b product at the CharitDe Berlin, one of the largest
university hospitals in Europe. The sites will fall under the direction of
Professor Achim Schneider, MD, MPH, the principal investigator for the study,
and are expected to begin enrolling patients immediately.
"We are pleased to add these new clinical sites," said Dr. Don Segal,
President and CEO of Helix BioPharma. "The opening of these new sites grants
us access to expanded clinical resources and a larger pool of potential
patients for this trial."
The study, which began in November 2004 at the Friedrich-Schiller-
University in Jena, Germany, is designed to evaluate the efficacy and safety
of Topical Interferon Alpha-2b in the treatment of women with low-grade
squamous intraepithelial lesions ("LSIL") that are positive for human
papilloma virus ("HPV") infection. LSIL represents the mild-to-moderate forms
of cervical dysplasia, which may progress to cervical cancer in women. In the
United States alone, an estimated one million women annually are diagnosed
with LSIL. At present, there is no pharmaceutical therapy available to these
patients. The trial is scheduled for completion in 2006.

About CharitDe Berlin
CharitDe Berlin is one of the largest university hospitals in Europe
comprising four campuses: Benjamin Franklin, Berlin-Buch, CharitDe Mitte and
Virchow clinical center. Its researchers have been recognized internationally
for their work on HPV and cervical cancer.

About Interferon alpha-2b and 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, 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 discreet,  
self-administered, pain-free therapeutic alternative to injections 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
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 main product development programs are for 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 current clinical
trial being conducted in Europe. Forward-looking statements can be identified
by the use of forward-looking terminology such as "should allow",
"ultimately", "scheduled", "expected", "anticipates", "new", or variations
thereon 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 in 2006 or at all; uncertainty whether the trial results
will show efficacy and safety of Topical Interferon Alpha-2b as anticipated or
at all; uncertainty whether the additional sites will affect the pace of
enrolment in the trial; 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 and 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 Topical Interferon Alpha-2b
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 its latest Annual Information Form filed with the
Canadian Securities Regulatory Authorities at www.sedar.com, 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.