Helix BioPharma Corp. Initiates Enrollment for Eighth Cohort in Polish Phase I/II Clinical Study of Its Lung Cancer Drug Cand...
08 4월 2014 - 5:30AM
Marketwired
Helix BioPharma Corp. Initiates Enrollment for Eighth Cohort in
Polish Phase I/II Clinical Study of Its Lung Cancer Drug Candidate
L-DOS47
AURORA, ON--(Marketwired - Apr 7, 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
eighth 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
in the three patients enrolled in the seventh dose level cohort, in
which L-DOS47 therapy was well tolerated as reviewed by the Trial
Steering Committee.
Helix intends to initiate and submit to Polish regulatory
authorities for approval a protocol amendment that would continue
dose escalation for the Phase I component of the study beyond
Cohort 8 in the event the maximum tolerated dose ("MTD") is not
reached in Cohort 8.
As previously disclosed, the planned enrolment in the study
depends on how many dose levels are required to reach
MTD. Helix originally estimated that MTD would be reached
after enrolling eight cohorts of three patients each; however, none
of the treatment related adverse events reported to date have met
the definition of a dose-limiting toxicity.
"We are pleased to see this safety profile for L-DOS47, and our
application to continue dose escalation, if approved, will provide
us with the ability to gather the best possible information for
further continued development of our lead candidate. Higher doses
evaluated in this study can potentially provide greater insight
into its use in future safety and efficacy studies," said Robert
Verhagen, President and Chief Executive Officer of Helix. "The
company will provide a more detailed update on the status of the
first seven patient cohorts by the end of the second calendar
quarter of 2014."
L-DOS47 is Helix's first immunoconjugate-based drug candidate in
development based upon Helix'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 eighth cohort will receive the next L-DOS47 dose level as
planned in the study protocol, which is 1.38 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, the anticipated approval of the protocol amendment
to permit the enrollment of patients beyond Cohort 8 of such study,
the potential generation of valuable information by such further
enrollment of patients and the anticipated timing for the delivery
of an update on the status of the first seven patient cohorts,
which may be identified by words including, without limitation,
"will", "may", "estimated", "intends", 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 and that the information,
if any, gained from higher dose levels in such study will not be of
use in future studies; (v) the potential that Polish regulatory
bodies may not accept Helix's proposed protocol amendment to permit
the enrollment of patients beyond Cohort 8 in a timely fashion or
at all; 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
Polish regulatory bodies will accept Helix's proposed protocol
amendment to permit the enrollment of patients beyond Cohort 8 on
the timelines anticipated by Helix, and 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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