Helix BioPharma Corp. Completes Enrollment in Its Phase II Trial of Topical
Interferon Alpha-2b in Patients With Ano-Genital Warts
AURORA, Ontario, Nov. 5 /PRNewswire-FirstCall/ -- Helix BioPharma Corp. (TSX,
FSE: "HBP" / OTCQX: HXBPF) announced today that its Phase II trial of Topical
Interferon Alpha-2b for the treatment of ano-genital warts (AGW) has completed
patient enrollment, with the required 120th patient randomized to enter the
trial.
The double-blind and placebo-controlled Phase II trial is underway at multiple
centers in Germany and Sweden. Patients participating in the trial
self-administer active treatment or control cream to the external ano-genital
region twice-daily, for five consecutive days per week over a treatment period
of eight weeks, with a follow-up visit at 16 weeks. Only female subjects were
enrolled in the trial in order to avoid inter-sex treatment variations. The
trial was designed to enroll 120 patients, whereby half were intended to
receive Topical Interferon Alpha-2b and the other half a vehicle cream
intended to serve as a placebo control. 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.
"This is an important milestone for Helix's Topical Interferon Alpha-2b
clinical program," said John Docherty, president and COO of Helix BioPharma.
"Our efforts to enhance the recruitment rate over recent months have been
successful, and we now look forward to obtaining the results of this trial
once all patient procedures and analyses are completed."
Moving forward, based on the trial design and schedule, Helix expects patients
to complete all study procedures by the early part of calendar 2010, followed
thereafter by closing of the database, analysis of the results and final
reporting in mid to late calendar 2010.
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. Treatment options today are limited by
tolerability issues such as pain, irritation and swelling at the treatment
site. Treatments may include topical preparations, intralesional injection of
interferon Alpha-2b and surgically ablative procedures. Helix believes that
more effective and better tolerated treatments are needed.
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 favored due to the fact that
conventional administration requires painful intralesional injection by a
medical professional. Furthermore, intralesional 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 utilizes the Company's proprietary Biphasix(TM) drug
delivery technology, and 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 by offering a
superior tolerability profile, but also from an efficacy standpoint.
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 Relations
Robert Flamm, Ph.D.
Russo Partners LLC
Tel: (212) 845-4226
Email: robert.flamm@russopartnersllc.com
www.russopartnersllc.com
Media Relations
Ian Stone
Russo Partners LLC
Tel: (619) 814-3510
Fax: (619) 955-5318
Email: ian.stone@russopartnersllc.com
Forward-Looking Statements and Risks and Uncertainties
This News Release contains certain forward-looking statements and
forward-looking information, within the meaning of applicable securities laws,
regarding the Company's planned Phase II trial (the "AGW trial") of Topical
Interferon Alpha-2b for the treatment of ano-genital warts (AGW), its expected
timing of completion of patient study procedures and of final reporting, and
other matters. Forward-looking statements and information can be identified
by the use of forward-looking terminology such as "will be", "looking
forward", "expected", "anticipates", "2010", or variations thereon, or
comparable terminology referring to future events or results. Although Helix
believes that the expectations reflected in such forward-looking statements
and information are reasonable, such statements and information involve risks
and uncertainties, and undue reliance should not be placed on such statements
and information. Certain material factors or assumptions are applied in making
forward-looking statements and providing forward-looking information,
including, but not limited to, completion of all AGW trial activities in
accordance with the trial design and schedule. Important risk factors and
uncertainties that could cause actual results to differ materially from these
forward-looking statements and information include, without limitation, the
Company's continuing need for additional capital, which may not be available
in a timely manner or at all and which if not obtained will have a material
adverse impact on the Company and its ability to continue, or if not obtained
in a timely manner, may result in the Company's having to discontinue or delay
one or more of its product development programs, including the AGW trial;
uncertainty whether Topical Interferon Alpha-2b will be successfully developed
and commercialized as a drug for the treatment of AGW or at all; uncertainty
whether any of the timelines mentioned in this press release will be achieved;
Helix's dependence on its third party service providers, including without
limitation, contract research organizations, contract manufacturing
organizations, clinical trial consultants, collaborative research consultants,
regulatory affairs advisors, and others, whose performance and interdependence
can critically affect the Company's performance and the achievement of its
milestones; the risk that the AGW trial may fail to meet expectations and that
further development of the drug candidate may be discontinued for the AGW
indication; the need for additional clinical trials, if the AGW trial does
meet expectations, to continue the development of the drug candidate, the
occurrence and success of which cannot be assured; product liability and
insurance risks; research and development risks, including the possibility
that further challenges may arise in connection with the scale-up
manufacturing of Topical Interferon Alpha-2b; the risk of obtaining negative
findings or factors that may become apparent during the course of research or
development, including during the course of the AGW trial, which may result in
the discontinuation or delay of the research or development projects; 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,
including without limitation, the risk that three patents for Topical
Interferon Alpha-2b will expire in 2013 and no additional patent may be
issued, that patent applications may not result in issued patents, that issued
patents may be circumvented or struck down, and the risk of potential claims
of infringement by the Company of third party intellectual property rights;
marketing/manufacturing and partnership/strategic alliance risks; the effect
of competition; uncertainty of the size and existence of a market opportunity
for Helix's product; the risk that the Company's supplier of interferon
alpha-2b may not continue to provide the Company with interferon alpha-2b or
exercise its commercialization option, which would have a negative effect on
the further development of the drug candidate and on the Company; and the risk
of changes in business strategy or development plans. Certain of these risks
and uncertainties, and others affecting the Company which could cause actual
results to vary materially from current results or those anticipated in
forward-looking statements and information, are more fully described in the
Company's latest MD&A, Form20-F and other reports filed with the Canadian
Securities Regulatory Authorities and the U.S. SEC from time to time at
www.sedar.com and www.sec.gov/edgar.shtml, respectively. Forward-looking
statements and information are based on the beliefs, assumptions, 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, assumptions, opinions or expectations
change, except as required by law.
SOURCE Helix BioPharma Corp.
Investor Relations: Robert Flamm, Ph.D., Russo Partners LLC, +1-212-845-4226,
robert.flamm@russopartnersllc.com; Media Relations: Ian Stone, Russo Partners
LLC, +1-619-814-3510, Fax: +1-619-955-5318, ian.stone@russopartnersllc.com
