Helix BioPharma Corp. to initiate new L-DOS47 clinical program in pancreatic cancer
November 01 2018 - 7:30AM
Helix BioPharma Corp. (TSX: HBP), (FSE: HBP) (“Helix” or the
“Company”), an immuno-oncology company developing innovative drug
candidates for the prevention and treatment of cancer, today
announced that it will initiate a new clinical program in
pancreatic cancer which will be led by Dr. Daniel D. Von Hoff. Dr.
Von Hoff is Physician-in-Chief at the Translational Genomics
Research Institute (“TGen”) and Professor of Medicine at both the
Mayo Clinic and the University of Arizona College of Medicine.
Pancreatic cancer is the third leading cause of
cancer death in the United States and is very difficult to treat.
Treatment options for advanced pancreatic cancer patients are
mostly limited to chemotherapy and in certain cases, radiotherapy
and surgery. Immunotherapy such as check-point inhibitors, are not
widely available as most drug candidates are still in clinical
development. It has been speculated that since pancreatic tumours
can have a very acidic profile, the application of immunotherapy
may be limited.
Based on preliminary but very encouraging
internal and collaborative research work with Dr. Robert Gillies of
the Moffitt Cancer Center, on animal pancreatic cancer, the Company
believes L-DOS47 with its purported action of combating tumour
acidity, may contribute significantly to the treatment of
pancreatic cancer.
The Company is very excited to work with Dr. Von
Hoff on this new clinical program. Dr. Von Hoff is a pioneer in
developing new cancer drugs and a prominent opinion leader in the
treatment of pancreatic cancer. Dr. Von Hoff’s clinical trial work
has led to the approval of three pancreatic cancer drugs by the
U.S. Food and Drug Administration (“FDA”) for the treatment of
patients with advanced pancreatic cancer.The first clinical study
being planned by the Company is a U.S. Phase I/II study of L-DOS47
in combination with Doxorubicin for the treatment of metastatic
pancreatic cancer. The Company is currently completing the study
protocol and will be looking to submit to the FDA, in the coming
months, an investigational new drug (“IND”) application.
Given Dr. Von Hoff’s new role in leading this
new clinical program, he will be stepping down as a member of the
Company’s Advisory Board, effective November 1, 2018. The Company
thanks Dr. Von Hoff for his contribution on the Advisory Board and
is very much looking forward to Dr. Von Hoff’s valuable
contributions in the Companies pancreatic cancer clinical
program.
“We are privileged to work with Dr. Von Hoff and
his team on this new clinical program” said Heman Chao, Helix’s
Chief Executive Officer. “Once approved by the FDA, L-DOS47 would
be tested in two different indications, lung and pancreatic cancer.
I look forward to starting this new study and am very excited about
expanding the indications of L-DOS47.”
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 and FSE under the
symbol “HBP”.
About L-DOS47
L-DOS47 is Helix's first immunoconjugate based
drug candidate in development based on the Company’s novel DOS47
platform 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.
Investor Relations
Helix BioPharma Corp.9120 Leslie Street, Suite
205Richmond Hill, Ontario, L4B 3J9Tel: 905-841-2300Email:
ir@helixbiopharma.com
Cautionary Statements
This news release may contain forward-looking
statements and information (collectively, "forward-looking
statements") within the meaning of applicable Canadian securities
laws. Forward-looking statements are statements and
information that are not historical facts but instead include
financial projections and estimates; statements regarding plans,
goals, objectives, intentions and expectations with respect to
Helix’s future business, operations, research and development,
including Helix’s activities relating to its drug development
program, the anticipated timelines for the commencement or
completion of certain activities, including enrolment of patients,
the expansion of the DOS47 platform into other compounds and
indications and other information in future periods.
Forward-looking statements, which may be identified by words
including, without limitation, “encouraging”, “may”, “improve”,
“planned”, “possible”, “postulated”, “enhances”, “potential”,
“development”, “unique”, “expects”, “plans”, “will”, “intends”,
“pending”, “objective”, “exploring”, “projected”, and other similar
expressions, are intended to provide information about management’s
current plans and expectations regarding future 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) 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) difficulties in
predicting accurate timelines for the commencement or completion of
certain activities including those in support of ongoing clinical
trials; (iv) positive preliminary results from early-stage clinical
trials may not be indicative of the final results from the trial or
be indicative of favorable outcomes in later-stage clinical trials;
(v) delays 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; (vi) clinical data may not
demonstrate adequate efficacy and safety to result in regulatory
approval to market any of Helix’s product candidates in any
jurisdiction; (vii) economic and market conditions may become worse
and market shifts may require a change in strategic focus; and
(viii) those risks and uncertainties affecting Helix 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 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.
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