Helix BioPharma Corp. to Conduct Interim Review of Its LDOS002 Phase I/II Clinical Study
09 September 2013 - 1:16PM
Marketwired
Helix BioPharma Corp. (TSX: HBP) (FRANKFURT: HBP), a
biopharmaceutical company developing drug candidates for the
treatment of cancer, today announced that it has completed patient
enrolment in the fourth cohort in its ongoing Phase I/II clinical
safety, tolerability and preliminary efficacy study of L-DOS47 and
will perform an interim review of data collected for all subjects
enrolled to date. The interim review will focus on safety,
tolerability and other clinical parameters of the Company's lead
clinical candidate, L-DOS47 for the treatment of non-small cell
lung cancer. Presentation to the Trial Steering Committee is
expected to occur in October of 2013, after the opening of
enrollment into the 5th cohort.
"We are currently dosing patients in our fourth cohort", said
Rob Verhagen, Chief Executive Officer of Helix. "The L-DOS47 dose
levels used on patients in the fourth cohort represent the first
dose which we believe to be within the range of theoretical minimum
effective dose. Based on animal studies, the human equivalent
theoretical minimum effective dose was calculated at 0.40 to 1.55
micrograms/kg, and the fourth cohort began doses of 0.46
micrograms/kg. This interim data review will allow the Company to
better understand the performance of our lead drug candidate
L-DOS47 and in turn help us develop next steps in our clinical
development path of this important candidate".
About L-DOS47
L-DOS47 is Helix's first immunoconjugate-based drug candidate in
development based upon the Company's novel DOS47 technology, which
is designed to use an innovative approach to modify the
microenvironmental conditions of cancer cells in a manner that
leads to their destruction. L-DOS47 is currently being clinically
evaluated as a treatment for certain patients with non-small cell
lung cancer ("NSCLC") in Helix's ongoing Phase I/II clinical
safety, tolerability and preliminary efficacy study of L-DOS47 in
Poland.
The Phase I/II clinical study is an open-label study to evaluate
the safety, tolerability and preliminary efficacy of ascending
doses of L-DOS47, initially as a monotherapy, in patients with
inoperable, locally advanced, recurrent or metastatic,
non-squamous, stage IIIb/IV NSCLC.
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 novel L-DOS47 new drug
candidate and its Topical Interferon Alpha-2b. Helix is currently
listed on the TSX and FSE under the symbol "HBP".
Forward-Looking Statements and Risks and
Uncertainties This news release contains certain
forward-looking statements and information (collectively,
"forward-looking statements") within the meaning of applicable
Canadian securities laws, including, without limitation, those
relating to the potential benefits of Helix's DOS47 platform in the
treatment of cancer and the anticipated scope of and timing for the
completion of Helix's interim review of data collected in
connection with Helix's ongoing Phase I/II clinical study in
Poland. Forward-looking statements, which may be identified by
words including, without limitation, "will", "intends", "expected"
and other similar expressions, are intended to provide information
about management's current plans and expectations regarding future
operations.
Although Helix believes that the expectations reflected in such
forward-looking statements are reasonable, such statements involve
risks and uncertainties that may cause actual results or events to
differ materially from those anticipated and no assurance can be
given that these expectations will be realized, and undue reliance
should not be placed on such statements. Risk factors that could
cause actual results or events to differ materially from the
forward-looking statements include, without limitation, (i) the
inherent uncertainty involved in scientific research and drug
development; (ii) the risks associated with delay or inability to
complete clinical trials successfully; (iii) need to secure
additional financing on terms satisfactory to Helix or at all; (iv)
clinical trials that yield negative results, or results that do not
justify future clinical development, including that the Polish
Phase I/II clinical trial for L-DOS47 will yield negative results;
and (v) those risks and uncertainties affecting the company as more
fully described in Helix's most recent Annual Information Form,
including under the headings "Forward-Looking Statements" and "Risk
Factors", filed with the Canadian Securities Administrators at
www.sedar.com (together, the "Helix Risk Factors"). Certain
material factors or assumptions are applied in making the
forward-looking statements, including, without limitation, that the
Helix Risk Factors will not cause Helix's actual results or events
to differ materially from the forward-looking statements.
Forward-looking statements and information are based on the
beliefs, assumptions and expectations of Helix's management on the
date of this news release, and Helix does not assume any obligation
to update any forward-looking statement or information should those
beliefs, assumptions or expectations, or other circumstances
change, except as required by law.
Investor Relations: Helix BioPharma Corp. Tel: 905
841-2300 Email: ir@helixbiopharma.com
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