Helix BioPharma Corp. Initiates Enrollment for Seventh Cohort in Polish Phase I/II Clinical Study of Its Lung Cancer Drug Can...
February 18 2014 - 4:40PM
Marketwired
Helix BioPharma Corp. Initiates Enrollment for Seventh Cohort in
Polish Phase I/II Clinical Study of Its Lung Cancer Drug Candidate
L-DOS47
AURORA, ON--(Marketwired - Feb 18, 2014) - Helix BioPharma Corp.
(TSX: HBP) (FRANKFURT: HBP), a biopharmaceutical company developing
innovative drug candidates for the prevention and treatment of
cancer, today announced the opening of patient screening for the
seventh dose level cohort in its ongoing Phase I/II clinical
safety, tolerability and preliminary efficacy study of L-DOS47 in
Poland. This follows completion of the first treatment cycle
of the three patients enrolled in the sixth dose level cohort,
in which L-DOS47 therapy was well tolerated as reviewed by the
Trial Steering Committee.
"Considering the response from the Trial Steering Committee,
L-DOS47 continues to be well tolerated by study patients," said
Robert Verhagen, President and Chief Executive Officer of
Helix. 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").
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. The study commenced with a
starting dose of 0.12 micrograms of L-DOS47 per kilogram of patient
body weight in the first patient cohort. Patients to be enrolled in
the seventh cohort will receive the next L-DOS47 dose level as
planned in the study protocol, which is 1.04 micrograms of L-DOS47
per kilogram of patient body weight.
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 total
number of patients that will be enrolled in the Polish Phase I/II
clinical study. Forward-looking statements, which may be
identified by words including, without limitation, "will",
"may", and other similar expressions, are intended to provide
information about management's current plans and expectations
regarding the conduct of the clinical study.
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, including that patient
recruitment for the Polish Phase I/II clinical trial for L-DOS47
does not continue as scheduled or at all, and the long lead-times
and high costs associated with obtaining regulatory approval to
market any product which may result from successful completion of
such trials; (iii) the need to secure additional financing;
(iv) that clinical trials will 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
Report, including under the headings "Forward-Looking Statements"
and "Risk Factors", filed under Helix's profile on SEDAR 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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