Helix BioPharma Corp. Receives U.S. Food & Drug Administration Approval to Initiate a Clinical Trial of L-DOS47 in Combinatio...
April 22 2014 - 7:30AM
Marketwired
Helix BioPharma Corp. Receives U.S. Food and Drug Administration
Approval to Initiate a Clinical Trial of L-DOS47 in Combination
With Pemetrexed and Carboplatin
AURORA, ON--(Marketwired - Apr 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 that it has received approval from the U.S.
Food and Drug Administration ("FDA"), to initiate a Phase I
clinical trial with L-DOS47.
The study is entitled "A Phase I, Open Label, Dose Escalation
Study of Immunoconjugate L-DOS47 in Combination with Standard
Doublet Therapy of Pemetrexed/Carboplatin in Patients with Stage IV
(TNM M1a and M1b) Recurrent or Metastatic Non-Squamous Non-Small
Cell Lung Cancer".
The study is designed as a dose-escalation cohort study in
first-line lung cancer patients. Patients will receive L-DOS47 in
combination with standard chemotherapy of pemetrexed/carboplatin.
Based on the ongoing review of safety data from study LDOS002 being
conducted in Poland, the recommended starting dose of L-DOS47 is
0.59 µg/kg, and dose will be escalated upon review of each cohort
by the Safety Steering Committee. Once maximum tolerated dose
("MTD") is reached, up to an additional 10 patients will be
recruited to evaluate overall response rates.
"We are pleased with this approval to begin the next steps of
our clinical development plan" said Robert Verhagen, President and
CEO of Helix. "Our goal for L-DOS47 is to identify the best
possible use of this drug candidate in combination with other
chemotherapeutic and targeted agents. We believe that L-DOS47 has
the potential for real value in additive or synergistic
combinations with currently marketed therapies. This trial, once
funded and initiated, will be the first step towards realizing that
value in patients undergoing first line therapy."
About the Study
The study is designed as a dose-escalation study in first-line
Non-Small Cell Lung Cancer patients. Patients will be recruited
into cohorts, with a minimum of 3 and a maximum of 6 patients per
cohort. Based on the ongoing review of safety data from study
LDOS002, the recommended starting dose of L-DOS47 is 0.59 µg/kg.
Patients will receive L-DOS47 in combination with standard
chemotherapy of pemetrexed/carboplatin, and dose will be escalated
upon review by the Safety Steering Committee. Once MTD is reached,
up to an additional 10 patients will be recruited to evaluate
overall response rates.
Patients will receive up to four cycles of the combination
treatment. Patients who have not progressed following the 4 cycles
of combination treatment and who have not experienced unacceptable
toxicity will have the opportunity to continue to receive
additional cycles of L-DOS47 treatment for as long as there is
clinical benefit and it is well-tolerated. Patients who are unable
to complete 4 cycles of L-DOS47 + pemetrexed/carboplatin
combination treatment due to pemetrexed/carboplatin toxicity will
have the opportunity to continue receiving L-DOS47 treatment
following discontinuation of pemetrexed/carboplatin, for as long as
there is clinical benefit and it is well-tolerated.
Primary
Objectives:
- Safety and tolerability of L-DOS47 in combination treatment
with pemetrexed/carboplatin.
- Determination of dose limiting toxicity of L-DOS47 in
combination treatment with pemetrexed/carboplatin.
- Determination of MTD and recommended Phase II dose of L-DOS47
in combination treatment with pemetrexed/carboplatin.
Secondary
Objectives:
- Objective response rate of the combination treatment according
to RECIST 1.1
- Evaluation of clinical benefit, defined as the percentage of
patients who have achieved complete response, partial response, and
stable disease following combination treatment with L-DOS47 in
combination with pemetrexed/carboplatin.
Exploratory
Objectives:
- Evaluation of the pharmacokinetics of L-DOS47 in combination
treatment with pemetrexed/carboplatin.
- Evaluation of the immunogenicity of L-DOS47.
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. Forward-looking statements, which may be identified by words
including, without limitation, "will", "may", "intends, and other
similar expressions are intended to provide information about
management's current plans and expectations.
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 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, including that the additional
funding required in order to initiate the proposed U.S. Phase I
clinical trial will be obtained 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 Helix's ongoing Polish Phase I/II clinical trial for L-DOS47
and/or that Helix's proposed U.S. Phase I clinical trial will yield
negative results; (v) Helix's clinical development plan for the
proposed Phase I clinical trial does not proceed in the manner or
on the timelines anticipated by Helix or at all; and (vi) those
risks and uncertainties affecting the company as more fully
described in Helix's most recent Annual Information Form, 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 and assumptions
are applied in making the forward-looking statements, including,
without limitation, that Helix will receive the funding necessary
to initiate the proposed U.S. Phase I clinical trial will be
received 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)
Historical Stock Chart
From Aug 2024 to Sep 2024
Helix BioPharma (TSX:HBP)
Historical Stock Chart
From Sep 2023 to Sep 2024