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-No serious adverse drug reactions seen-
-Study findings to be reported in first quarter of 2007-
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AURORA, ON, Nov. 14 /CNW/ - Helix BioPharma Corp. (TSX, FSE: "HBP")
announced today completion of enrollment and treatment in its Phase 2 clinical
study of Topical Interferon Alpha-2b in women with low-grade squamous
intraepithelial lesions ("LSIL") that are positive for human papilloma virus
("HPV") infection.
The study was designed to evaluate the safety and effectiveness of
Topical Interferon Alpha-2b in patients with cytologically confirmed LSIL and
polymerase chain reaction ("PCR") confirmed HPV. Patients received Topical
Interferon Alpha-2b therapy applied intravaginally three times a week for a
period of six weeks, followed by a six week follow-up period. The primary
study endpoint is to determine the proportion of patients with resolution of
their abnormal Pap smear during the twelve week study duration. Other study
assessments include safety and tolerability, pre- and post-study histological
examinations by way of colposcopy and qualitative assessment of HPV-positive
status using PCR. In addition, the Company studied a second patient population
that received no treatment whatsoever as a comparator to the treatment
population.
As planned, 40 patients were enrolled across the two patient groups,
divided into 20 patients in each group. No serious adverse drug reactions were
reported in the study. The Company is completing analytical work on patient
samples collected over the duration of the patient testing and will be
gathering and analyzing the final data. The Company expects to complete all
data analyses and report the final integrated study findings during the first
quarter of calendar 2007.
The Phase 2 study was conducted at four clinical sites in Germany under
the guidance of Prof. Achim Schneider, MD, MPH, a world expert in the field of
cervical cancer. Prof. Schneider is the Director of the Department of
Gynecology at one of the largest university hospitals in Europe, The
CharitDe-Universitatsmedizin Berlin.
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
certain HPV induced lesions, 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 "estimates", "expected", "anticipates", 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 report of the
findings of the Topical Interferon Alpha-2b study will be available as
estimated; uncertainty whether the study results will show efficacy and safety
of Topical Interferon Alpha-2b as anticipated or at all; 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 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 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.
