Helix receives approval to conduct a clinical trial of Topical Interferon Alpha-2b in Sweden

AURORA, ON, Sept. 12 /CNW/ - Helix BioPharma today announced that it has
received approval from Sweden's drug regulatory authority, the Medical
Products Agency (MPA), to conduct a Phase II clinical trial of Topical
Interferon Alpha-2b in patients with ano-genital warts (condylomata
acuminata), who are positive for infection with the human papilloma virus
(HPV).
The trial is intended to assess the efficacy and safety of Topical
Interferon Alpha-2b compared with placebo using a double-blind, randomized
design. The trial will be conducted at multiple centers in Sweden, under the
direction of Dr. Pal Wolner-Hanssen, the coordinating investigator who is
located at the University Hospital of Lund.
"We are very pleased to receive this approval from MPA after months of
preparations," said Mr. John Docherty, Vice President of Corporate Development
for Helix BioPharma Corp. "This is a critical step towards commencing the
clinical program for the second major indication to be sought for Topical
Interferon Alpha-2b."
Based on having received this approval, the Company intends to commence
preparations to conduct the trial, with a view to beginning the trial in
concert with raising additional required capital.
Helix's Topical Interferon Alpha-2b is currently being assessed
clinically in a multi-center Phase II study in Germany for the treatment of
Low-Grade Squamous Intraepithelial Lesions (LSIL), a form of cervical
dysplasia, in women who are positive for HPV infection. The Company is
developing Topical Interferon Alpha-2b for two indications, LSIL and        
ano-genital warts.

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 US Center for Disease Control (CDC) estimates that
more than 1.4 million people develop ano-genital warts each year in the US
alone.

Topical Interferon Alpha-2b and Ano-Genital Warts

Helix is developing Topical Interferon Alpha-2b for liberal application
to the genitalia of patients with ano-genital warts as a means of delivering
potent interferon alpha-2b therapy intradermally, across the entire surface of
the external genital skin/mucosa, in order to combat the underlying viral
infection. Interferon alpha-2b is believed to function therapeutically in an
immunomodulatory fashion by promoting an innate immune system response to
viral pathogens, including HPV.

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, which statements can be
identified by the use of forward-looking terminology such as "to conduct", "is
intended", "towards commencing", "with a view to", "to seek", or variations
thereon, or that events "can", "should" or "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 proposed Swedish clinical trial will be
commenced or completed as proposed or at all; uncertainty whether the trial
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 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 news releases and 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.