Helix BioPharma Corp. Initiates Enrollment for Sixth Cohort in Polish Phase I/II Clinical Study of Its Lung Cancer Drug Candi...
2014年1月23日 - 7:13AM
Marketwired
Helix BioPharma Corp. Initiates Enrollment for Sixth Cohort in
Polish Phase I/II Clinical Study of Its Lung Cancer Drug Candidate
L-DOS47
AURORA, ON--(Marketwired - Jan 22, 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
sixth 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 fifth dose level cohort, in which L-DOS47
therapy was well tolerated as reviewed by the Trial Steering
Committee.
"With the opening of the sixth cohort, we continue to be on
track to complete enrolment in the Phase I component of the study
by the summer of 2014," said Robert Verhagen, President and Chief
Executive Officer of Helix. "Also, we have opened an additional
site to support both dose escalation and cohort expansion." 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 sixth cohort will receive the next L-DOS47 dose level as
planned in the study protocol, which is 0.78 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 and the addition of centres to the study.
Forward-looking statements, which may be identified by words
including, without limitation, "will" 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) 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; (v) the risk that
additional centres satisfactory to Helix may not be identified in a
timely manner or at all and that such additional centres, if
opened, may not accelerate the anticipated timeline for the Polish
Phase I/II clinical trial for L-DOS 47; and (vi) 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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