Helix BioPharma Corp. Submits L-DOS47 Investigational New Drug Application With U.S. Food and Drug Administration
2014年4月4日 - 6:14AM
Marketwired
Helix BioPharma Corp. Submits L-DOS47 Investigational New Drug
Application With U.S. Food and Drug Administration
AURORA, ON--(Marketwired - Apr 3, 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 an Investigational
New Drug ("IND") application with the U.S. Food and Drug
Administration ("FDA") 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 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 ("NSCLC").
"This is a very positive step forward in the development of
L-DOS47," said Robert Verhagen, President and Chief Executive
Officer of Helix. "While our Polish Study will provide vital
information on our candidate as a monotherapy, our goal for this
study, if approved by the FDA, will be to understand how L-DOS47
will work in combination with other chemotherapeutic agents."
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 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", 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 the FDA of the Company's Investigational New Drug
application; (ii) the need to secure additional financing in order
to initiate the proposed U.S. Phase I clinical trial, and that such
financing may not be available on terms satisfactory to Helix or at
all; and (iii) 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 the
FDA will approve Helix's Investigational New Drug application, that
Helix is able to obtain financing on terms satisfactory to it
(including the funding required to initiate the proposed U.S. Phase
I clinical trial following approval by the FDA) 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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