Medexus Reaches 50% Enrollment in IXINITY® Phase 4 Clinical Trial Targeting Label Expansion for Pediatric Hemophilia B Pati...
November 16 2020 - 7:00AM
Medexus Pharmaceuticals Inc. (the
“Company” or “Medexus”)
(TSXV: MDP,
OTCQX:
MEDXF) today announced it has
reached the 50% enrollment target in its Phase 4 clinical trial
investigating IXINITY® as a prophylactic treatment for pediatric
patients under 12 years of age with hemophilia B, a hereditary
bleeding disorder characterized by a deficiency of clotting factor
IX. IXINITY is an FDA approved intravenous recombinant factor IX
therapeutic for use in patients 12 years of age or older with
hemophilia B.
On February 28, 2020, Medexus announced the
acquisition of the worldwide rights to the commercial hematology
asset, IXINITY®, from Aptevo Therapeutics, Inc. (NASDAQ:
APVO). In January 2020, Aptevo had already commenced
dosing patients in a Phase 4 clinical trial to evaluate the safety
and efficacy of IXINITY® in previously treated patients under 12
years of age with hemophilia B. Once completed, this study may
support a significant expansion of the indicated patient population
for IXINITY®. According to the World Federation of Hemophilia
‘Report on the Annual Global Survey 2017,' approximately 1 in 3
patients treated for hemophilia B in the U.S. are 12 years of age
or younger.
Khaled Mohamed, Director of Regulatory Affairs
for Medexus, commented, “We are encouraged by the steady progress
of our IXINITY® Phase 4 pediatric clinical trial, as we have now
reached the 50% enrollment target and are on track to complete
enrollment by the second calendar quarter of 2021. We look forward
to completing this current study, which we are hopeful will allow
us to expand the product label to include the U.S. pediatric
population below 12 years of age.”
Ken d’Entremont, Chief Executive Officer of
Medexus, continued, “The hemophilia B market in the U.S. alone is
estimated to be in excess of USD $1 billion. Since the pediatric
segment is estimated to represent one-third of the hemophilia B
population, a label expansion represents a possible expansion of
the potential for IXINITY®. Most importantly, we look forward to
providing this important, additional therapy option to the
pediatric population. Previously reported and pooled data
from Phase 3 clinical trials demonstrated IXINITY® to be safe and
well tolerated in preventing and controlling bleeding episodes in
previously treated children under the age of 12 with hemophilia B.
We remain determined to advance our IXINITY® Phase 4 pediatric
clinical trial and look forward to providing further updates as we
achieve key milestones.”
Medexus intends to also pursue out-license
partners for IXINITY® in markets outside of Canada and the United
States. The company will provide further updates as they
develop.
About Medexus Pharmaceuticals
Inc.Medexus is a leading specialty pharmaceutical company
with a strong North American commercial platform. The Company’s
vision is to provide the best healthcare products to healthcare
professionals and patients, through our core values of Quality,
Innovation, Customer Service and Teamwork. Medexus Pharmaceuticals
is focused on the therapeutic areas of auto-immune disease,
hematology and allergy. The Company’s leading products are: Rasuvo™
and Metoject®, a unique formulation of methotrexate (auto-pen and
pre-filled syringe) designed to treat rheumatoid arthritis and
other auto-immune diseases; IXINITY®, an intravenous recombinant
factor IX therapeutic for use in patients 12 years of age or older
with Hemophilia B – a hereditary bleeding disorder characterized by
a deficiency of clotting factor IX in the blood, which is necessary
to control bleeding; and Rupall®, an innovative prescription
allergy medication with a unique mode of action.
For more information, please
contact: Ken d’Entremont, Chief Executive OfficerMedexus
Pharmaceuticals Inc.Tel.: 905-676-0003E-mail:
ken.dentremont@medexus.com
Roland Boivin, Chief Financial OfficerMedexus
Pharmaceuticals Inc.Tel.: 514-762-2626 ext. 202E-mail:
roland.boivin@medexus.com
Investor Relations (U.S.):Crescendo
Communications, LLCTel: +1-212-671-1020Email:
mdp@crescendo-ir.com
Investor Relations (Canada):Tina ByersAdelaide
CapitalTel: 905-330-3275E-mail: tina@adcap.ca
Neither the TSX Venture Exchange nor its
Regulation Services Provider (as that term is defined in the
policies of the TSX Venture Exchange) accepts responsibility for
the adequacy or accuracy of this release.
READER ADVISORIES
Forward Looking Statements
Certain statements made in this press release
contain forward-looking information within the meaning of
applicable securities laws (“forward-looking
statements”). The words “anticipates”, “believes”,
“expects”, “will”, “plans” and similar expressions are often
intended to identify forward-looking statements, although not all
forward-looking statements contain these identifying words.
Specific forward-looking statements contained in this news release
include, but are not limited to, statements with respect to the
potential expansion of the indicated patient population for
IXINITY® and possible expansion of potential for IXINITY®, the
timing for completion of enrollment in the Phase 4 pediatric
clinical trial and the intent to pursue out-license partners for
IXINITY®. These statements are based on factors or assumptions that
were applied in drawing a conclusion or making a forecast or
projection, including assumptions based on historical trends,
current conditions and expected future developments. Since
forward-looking statements relate to future events and conditions,
by their very nature they require making assumptions and involve
inherent risks and uncertainties. The Company cautions that
although it is believed that the assumptions are reasonable in the
circumstances, these risks and uncertainties give rise to the
possibility that actual results may differ materially from the
expectations set out in the forward-looking statements. Material
risk factors include those set out in the Company's most recent
MD&A; future capital requirements and dilution; intellectual
property protection and infringement risks; competition (including
potential for generic competition); reliance on key management
personnel; the Company’s ability to implement its business plan;
the Company’s ability to leverage its United States and Canadian
infrastructure to promote additional growth, including with respect
to the infrastructure of Medexus Inc. and Medac Pharma, Inc. and
the potential benefits the Company expects to derive therefrom;
regulatory approval by the Canadian health authorities; product
reimbursement by third party payers; patent litigation or patent
expiry; litigation risk; stock price volatility; government
regulation; and potential third party claims. Given these risks,
undue reliance should not be placed on these forward-looking
statements, which apply only as of the date hereof. Other than as
specifically required by law, the Company undertakes no obligation
to update any forward-looking statements to reflect new
information, subsequent or otherwise.
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