Helix BioPharma Corp. Initiates Enrollment for Fifth Cohort in Polish Phase I/II Clinical Study of Its Lung Cancer Drug Candi...
30 9월 2013 - 8:30PM
Marketwired
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 fifth 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 fourth dose
level cohort, in which L-DOS47 therapy was well tolerated as
reviewed by the Trial Steering Committee. Patients to be enrolled
in the fifth cohort will receive the next L-DOS47 dose level as
planned in the study protocol, 0.59 micrograms of L-DOS47 per
kilogram of patient body weight.
"L-DOS47 clinical program continues to advance well and with the
completion of the fourth cohort, and the opening of the fifth
cohort, we are on track to conduct the interim review as planned
for October" said Robert Verhagen, 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").
About the Clinical Study
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 enrolled in the study will receive two weekly doses of
L-DOS47, administered as an intravenous infusion, over 14 days,
followed by 7 days' rest (one treatment cycle is 3 weeks). For each
patient enrolled in the study, treatment with L-DOS47 will continue
until the patient experiences disease progression or unacceptable
toxicity, the patient withdraws consent, or the patient has
completed four treatment cycles and does not wish to continue with
additional cycles, whichever occurs first. After four treatment
cycles, at the discretion of the treating investigator and in
consultation with the medical monitor, patients who experience
clinical benefit may be eligible to continue L-DOS47 for as long as
the treatment is well tolerated and the clinical benefit is
sustained.
The total number of patients to be enrolled in the study will
ultimately depend on how many ascending dose levels are required to
reach the maximum tolerated dose (MTD); however, the Company
currently anticipates that the study will enroll less than the
estimated maximum of 48 patients in Phase I as previously reported.
Twenty patients will be enrolled in the Phase II portion of the
study at the MTD dose determined in Phase I. Study patients will be
male or female, at least 18 years of age, with histologically
confirmed non-small cell lung cancer. Patients will have an Eastern
Cooperative Oncology Group ("ECOG") performance status of 0 - 2 at
the screening visit for this study, and will have at least one site
of measurable disease per RECIST v1.1.
Efficacy evaluation of L-DOS47 will be based upon response rate
using the RECIST version 1.1 criteria, disease progression and
survival. Monitoring will include radiologic evaluations every
second treatment cycle.
The study is currently being conducted at four Polish centres
under the direction of Prof. Maciej Krzakowski, MD, PhD at The
Maria Sklodowska-Curie Memorial Cancer Centre & Institute of
Oncology as the overall coordinating investigator, together with
three other principal investigators: Prof. Cezary Szczylik, MD, PhD
at the Military Medical Institute, Prof. Elzbieta Wiatr, MD, PhD at
the National Tuberculosis and Lung Diseases Research Institute and
Dr. Aleksandra Szczensa, MD, PhD at the Mazovian Centre of
Pulmonary Diseases and Tuberculosis in Otwock. As previously
reported the Company is actively recruiting new centers to
participate in order to expand this study.
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", "may", "anticipates", "estimate", "continuing", 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 (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 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 opening of the additional centres will
not negatively affect the management, operations or timelines
associated with Helix's Polish Phase I/II clinical trial for
L-DOS47 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
Helix BioPharma (TSX:HBP)
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