L-DOS47 Phase II Randomized Study Advances to Second Cohort
May 01 2019 - 8:08AM
Helix BioPharma Corp. (TSX: HBP), (“Helix” or the “Company”), an
immuno-oncology company developing innovative drug candidates for
the prevention and treatment of cancer, has announced that the
Trial Steering Committee ("TSC") reviewed safety data from the
first dosing cohort of the Company’s LDOS003 study. No
serious adverse events or dose limiting toxicities were
observed. TSC recommended that Helix begin enrollment of
patients into the second dosing cohort.
LDOS003 is a Phase II, open-label, randomized
study of immunoconjugate L-DOS47 in combination with vinorelbine
and cisplatin as compared to vinorelbine and cisplatin alone in
patients with lung adenocarcinoma. The study is divided into two
parts. In part I, the maximum tolerated dose of L-DOS47, when given
in combination with vinorelbine/cisplatin, will be
determined. Cohorts of 3 patients will be recruited into
three dosing cohorts (6, 9 and 12 µg/kg). All patients at a given
dose level must complete the first treatment cycle (3-week period)
before escalation in subsequent patients can proceed. In part
II, after the maximum tolerated dose of L-DOS47 in combination with
vinorelbine/cisplatin has been determined, a further 118 patients
will be randomized (1:1) to receive L-DOS47 in combination with
vinorelbine/cisplatin, or vinorelbine/cisplatin alone.
“We are very encouraged that the first dosing
cohort of this L-DOS47 phase II study in combination with
chemotherapy has been completed,” said Heman Chao, Helix's Chief
Executive Officer. “We look forward to receiving more data as
we advance the L-DOS47 development program.”
About L-DOS47 clinical
development
L-DOS47 is currently being clinically evaluated
in three clinical studies, in the United States, Poland and Ukraine
as a treatment for certain patients with non-small cell lung cancer
(“NSCLC").
LDOS001 is a Phase I, open-label, dose
escalation study being conducted in the United States at the
University Hospitals Case Medical Center. The primary objective of
the study is to determine the safety and tolerability of L-DOS47 in
combination treatment with pemetrexed/carboplatin. The study will
also evaluate the potential clinical benefit of L-DOS47 with this
combination. Patient enrollment is active for this
study.
LDOS002 is an open-label Phase I/II clinical
study being conducted in Poland 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. Patient enrollment has completed for this
study.
LDOS003 is a phase II, open-Label, randomized
study of L-DOS47 in combination with vinorelbine/cisplatin as
compared to vinorelbine/cisplatin alone in patients with Lung
adenocarcinoma. The primary objectives of the study include safety,
tolerability and efficacy of L-DOS47 in this combination
treatment. Patient enrollment is about to commence for
this study.
About Helix BioPharma Corp.
Helix BioPharma Corp. is an immuno-oncology
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 Chimeric Antigen Receptor (“CAR”) based cell
therapies. Helix is currently listed on the TSX under the symbol
“HBP”.
Cautionary Statements
This news release may contain forward-looking
statements with respect to Helix, its operations, strategy,
financial performance and condition, including its activities
relating to its drug development program, any anticipated timelines
for the commencement or completion of certain activities such as
raising sufficient capital, merger and acquisition activity,
listing on a U.S. exchange and other information in future periods.
These statements generally can be identified by use of
forward-looking words such as “may”, “will”, “expect”, “estimate”,
“anticipate”, “intends”, “believe” or “continue” or the negative
thereof or similar variations. The actual results and performance
of discussed herein could differ materially from those expressed or
implied by such statements. Such statements are qualified in their
entirety by the inherent risks and uncertainties surrounding future
expectations, including: (i) Helix’s ability to operate as a going
concern being dependent mainly on securing sufficient additional
financing in order to fund its ongoing research and development and
other operating activities; (ii) the generally inherent uncertainty
involved in scientific research and drug development and those
specific to Helix’s pre-clinical and clinical development programs
(DOS47, L-DOS47, V-DOS47 and CAR-T); (iii) that any transactions
contemplated herein are completed; and (iv) those risks and
uncertainties affecting Helix as more fully described in Helix’s
most recent Annual Information Form, which is available at
www.sedar.com (together, the “Helix Risk Factors”). Certain
material factors and assumptions are applied in making the
forward-looking statements, including, without limitation, that
sufficient financing will be obtained in a timely manner to allow
Helix to continue operations and implement its clinical trials in
the manner and on the timelines anticipated and that the Helix Risk
Factors will not cause Helix’s actual results or events to differ
materially from the forward-looking statements. These cautionary
statements qualify all such forward-looking statements.
Forward-looking statements and information are
based on the beliefs, assumptions, opinions, plans and expectations
of Helix’s management on the date of this news release, and the
Company does not assume any obligation to update any
forward-looking statement or information should those beliefs,
assumptions, opinions, plans or expectations, or other
circumstances change, except as required by law.
Investor Relations
Helix BioPharma Corp.
9120 Leslie Street, Suite 205
Richmond Hill, Ontario, L4B 3J9
Tel: 905-841-2300
Email: ir@helixbiopharma.com
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