AURORA, ON, March 30 /CNW/ - Helix BioPharma Corp. (TSX: HBP/Frankfurt:
Helix today announced positive results from its phase II clinical study
of its Topical Interferon Alpha-2b in women with human papilloma virus (HPV)
induced low-grade cervical lesions.
The study showed a clinically efficacious response to treatment in nearly
half of the treated patients. In addition, the product demonstrated an
excellent safety profile, with no significant local intolerance or
drug-related serious adverse event observations.
"Treated patients responded well, both in terms of efficacy and safety to
this new investigational therapeutic," said Prof. Dr. med. Achim Schneider
M.P.H., a world expert in the field of cervical cancer and Director of the
Department of Gynaecology at the Charité University Hospital in Berlin.
"Helix's product shows real promise as a practical and effective
pharmaceutical means of preventing cervical cancer development in women
presenting with HPV-induced cervical lesions", continued Prof. Schneider.
About the Clinical Study
A total of 41 women with cytologically confirmed, HPV-induced low-grade
squamous intraepithelial lesions (LSIL) of the cervix were studied across four
sites in Germany. Twenty women received Topical Interferon Alpha-2b,
self-administered intravaginally three times per week for a period of 6 weeks
with a follow-up evaluation at 12 weeks, compared with 21 separately studied
women who received no treatment whatsoever over the same study period.
The primary endpoint and main outcome for both groups was the
Pap-response rate defined as the proportion of patients with resolution of
their abnormal Pap smear LSIL cytology to normal during the 12 week study
duration. Pap smear normalization was considered to occur if the patient's Pap
smear improved to group II or better from any of Pap smear groups IIW through
IIID as per the common European standard, "Munich Classification System" of
LSIL cytology. Pap smear testing is a leading method to diagnose potentially
precancerous cervical disease caused by HPV in women today.
Nearly half (46.7%) of the women in the treated per-protocol population
had their abnormal Pap smears revert to normal during the 12 week period,
compared with only 15.8% of the untreated women (i.e., nearly a three-fold
improvement). Of these women, one treated patient's LSIL cytology returned
following the end of treatment, which suggests that a longer dosing regimen
may be advisable in future studies.
Furthermore, upon stratification of the patients according to the North
American definition of LSIL cytology (i.e., "The Bethesda Classification
System"), the relative difference in the Pap-response rate between the treated
and untreated patient groups increased substantially. Using this approach,
only those women who entered the study belonging to the Pap smear group IIID
classification (i.e., the more advanced/serious Pap smear diagnosis described
above) were evaluated. Of the women in the stratified per-protocol treatment
population, 41.7% experienced normalization of their Pap IIID smear, whereas
none (0.0%) of the untreated Pap IIID women experienced improvement.
Beyond the Pap-response rate efficacy parameter, all other efficacy
parameters evaluated showed the same tendency in favour of treatment. For
example, 60% of the treated women experienced resolution of their associated
abnormal cervical findings upon colposcopic diagnosis versus only 9.5% of the
"We are very pleased to have achieved this milestone in the continuing
development of our Topical Interferon Alpha-2b product candidate," said John
Docherty, Helix's Vice President of Corporate Development. "Helix is committed
to further advancing its clinical development program for this extremely
prevalent condition, in order to bring this product to market as expeditiously
About HPV and Cervical Cancer
Cervical cancer is a condition that develops in women caused by today's
most common sexually transmitted infection, HPV. HPV infections have grown to
epidemic proportions around the world, with over 6 million new cases arising
in the USA alone each year.
The development of cervical cancer is generally preceded by a series of
progressively worsening disease conditions of the cervix detectable upon
gynaecological exam and Pap smear testing. Each year, millions of women
worldwide present with potentially precancerous, abnormal cervical Pap smears
associated with HPV infection.
For women today, there are no available pharmaceutical treatments for
potentially precancerous cervical lesions. Instead, surgical or other ablative
techniques are practiced in an effort to destroy infected tissue and prevent
further disease progression, but, due to unwanted side effects, these
practices are generally restricted to only the more advanced patients.
Alternatively, new vaccines are becoming available to ideally prevent
infection with HPV from occurring in the first place, but, despite this,
millions of women are expected to continue to contract HPV and develop
potentially precancerous cervical lesions, and millions of additional women
are already infected in the world today.
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 a wide treatment surface 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".
This News Release contains certain forward-looking statements and
information regarding the Company's Topical Interferon Alpha-2b and the
Company's research and development initiatives, which statements and
information can be identified by the use of forward-looking terminology such
as "promise", "expected", "anticipates", "committed to", "further advancing",
"possible", 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 study will be
successfully developed and commercialized at all; 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
manner 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
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