Helix Biopharma Corp. Submits L-DOS47 Clinical Trial Application With Health Canada
14 Mai 2014 - 2:00PM
Marketwired
Helix Biopharma Corp. Submits L-DOS47 Clinical Trial Application
With Health Canada
AURORA, ON--(Marketwired - May 14, 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 recent submission of a Clinical Trial
Application with Health Canada for approval 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 Vinorelbine in Patients with Metastatic or
Advanced Solid Tumours.
"This is the next step in the development of L-DOS47," said
Robert Verhagen, President and Chief Executive Officer of Helix.
"Acidic pH microenvironment may limit the effectiveness of weakly
basic cytotoxic drugs employed in the treatment of solid tumours.
The possibility of combining L-DOS47 with a weakly basic agent like
vinorelbine may improve therapeutic outcomes for cancer
patients."
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. The Company currently has a European Phase I/II
L-DOS47 monotherapy clinical trial ongoing in Poland and has
recently received approval from the U.S. Food and Drug
administration for a Phase I clinical trial of L-DOS47 in
combination with pemetrexed/carboplatin.
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 with respect to the possible outcomes of combining
L-DOS47 with basic agents. Forward-looking statements, which may be
identified by words including, without limitation, "may", and other
similar expressions, are intended to provide information about
management's current plans and expectations regarding Helix's
business and operations.
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
rejection by Health Canada of the Company's Clinical Trial
Application; (ii) the need to secure additional financing in order
to initiate the proposed Canadian Phase I clinical trial, and that
such financing may not be available on terms satisfactory to Helix
or at all; (iii) the potential therapeutic outcomes from
combining L-DOS47 with a weakly basic agent like vinorelbine;
and (iv) 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
Health Canada will approve Helix's Clinical Trail Application, that
Helix is able to obtain financing on terms satisfactory to it
(including the funding required to initiate the proposed Canadian
Phase I clinical trial following approval by Health Canada) 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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