June 09, 2015 11:54am EDT
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New Preclinical Data further demonstrate the safety and efficacy
of MOD-5014 (FVIIa –CTP) for both Intravenous and Subcutaneous
Administration
MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (NYSE:OPK), today announced that the company will
present new data on its long-acting clotting Factor VIIa-CTP (MOD-5014)
at the International Society on Thrombosis and Haemostasis (ISTH) 2015
Congress being held June 20-25, 2015 in Toronto, Ontario, Canada. OPKO’s
Factor VIIa-CTP is a next-generation investigational therapy currently
in a Phase 2a U.S. based study for the treatment of patients with
hemophilia.
Currently, Factor VIIa therapy is available only as an intravenous (IV)
formulation, which requires frequent multiple infusions to treat a
bleeding episode due to Factor VIIa’s short half-life. In addition, the
requirement for multiple weekly infusions can be onerous for patients
interested in preventative prophylactic treatment of the disease,
especially children.
Previously presented pre-clinical data utilizing both intravenous and
subcutaneous administration in hemophilic animal models demonstrated the
long acting properties of Factor VIIa-CTP as compared to commercial
rFVIIa, with superior half-life, reduced bleeding and increased survival
for a significantly longer period.
Five abstracts were accepted for presentation at the upcoming ISTH
conference. The following abstracts will be presented from 5:00-7:00
p.m. local time on June 23-24 th .
PO062-TUE: EX-VIVO AND IN-VITRO COMPARATIVE ASSESSMENT
OF MOD-5014 (FACTOR VIIA-CTP), A NOVEL LONG-ACTING COAGULATION FACTOR TO
RECOMBINANT FVIIA
PO550-TUE: EFFECT OF A CARBOXY-TERMINAL PEPTIDE (CTP) ON FACTOR
VIIA ACTIVITY
PO594-WED: COMPREHENSIVE ASSESSMENT OF THE SAFETY AND EFFICACY OF
FACTOR VIIA-CTP SUPPORTING PHASE 2A STUDY
PO595-WED: FACTOR VIIA-CTP, A LONG-ACTING COAGULATION FACTOR
PROPOSING A NOVEL SUBCUTANEOUS (SC) ROUTE OF ADMINISTRATION FOR
PROPHYLACTIC TREATMENT –EFFICACY AND SAFETY IN PREPARATION FOR FIRST IN
HUMAN STUDY
PO048-WED: ASSESSMENT OF MOD-5014, A LONG ACTING FVIIA,
PHARMACOKINETIC, PHARMACODYNAMICS AND CORRECTION OF HEMOPHILIC
COAGULOPATHY IN DOGS WITH HEMOPHILIA A AS PART OF THE PREPARATION FOR
FIRST IN HUMAN STUDY
About Hemophilia
Patients with hemophilia do not produce adequate amounts of the clotting
factors that are necessary for effective blood clotting. In severe
hemophiliacs even a minor injury can result in blood loss that may
continue for days or weeks, with the potential for debilitating
permanent damage to joints and other organs and premature death.
According to the World Health Organization, more than 400,000 people
worldwide have hemophilia. Commercially available recombinant clotting
factors have enabled many hemophiliacs to live near-normal lives, but
frequent infusions and/or blood transfusions may be required.
Factor VIIa-CTP has been granted orphan drug designation in the U.S. and
Europe.
ABOUT OPKO HEALTH, INC.
OPKO is a multinational biopharmaceutical and diagnostics company that
seeks to establish industry-leading positions in large, rapidly growing
markets by leveraging its discovery, development and commercialization
expertise and novel and proprietary technologies. For more information,
visit http://www.opko.com .
This press release contains "forward-looking statements," as that
term is defined under the Private Securities Litigation Reform Act of
1995 (PSLRA), regarding product development efforts and other
non-historical facts about our expectations, beliefs or intentions
regarding our business, technologies and products, financial condition,
strategies or prospects, including statements regarding our expectations
about our long-acting version of clotting Factor VIIa (Factor VIIa-CTP)
for the treatment of bleeding episodes in patients with hemophilia A or
B with inhibitors to Factor VIII or Factor IX, whether Factor VIIa-CTP
has the potential for substantial improvement of the quality of life of
patients, via both IV and subcutaneous (SC) administration, whether
Factor VIIa-CTP will be able to be administered subcutaneously using a
simple injection and allow children and adults with hemophilia to easily
self-administer the drug at home on a prophylactic basis, whether we
will be in a position to be first to market with a longer acting Factor
VIIa product, expectations about market potential for Factor VIIa-CTP,
whether we will be able to successfully develop, obtain approval for and
launch sales of the Factor VIIa-CTP, and the expected completion dates
for our trials. Many factors could cause our actual activities or
results to differ materially from the activities and results anticipated
in forward-looking statements. These factors include those described in
our filings with the Securities and Exchange Commission, as well as
risks inherent in funding, developing and obtaining regulatory approvals
of new, commercially-viable and competitive products and treatments,
including the risks that clinical trials for Factor VIIa-CTP may not be
successful or achieve the expected results or effectiveness, and may not
generate data that would support the approval or marketing of this
product for the indications being studied, that others may develop
products which are superior to Factor VIIa-CTP, and that Factor VIIa-CTP
may not have advantages or prove to be superior over presently marketed
products. In addition, forward-looking statements may also be adversely
affected by general market factors, competitive product development,
product availability, federal and state regulations and legislation, the
regulatory process for new products and indications, manufacturing
issues that may arise, patent positions and litigation, among other
factors. The forward-looking statements contained in this press release
speak only as of the date the statements were made and we do not
undertake any obligation to update forward-looking statements. We intend
that all forward-looking statements be subject to the safe-harbor
provisions of the PSLRA.
View source version on businesswire.com: http://www.businesswire.com/news/home/20150609006306/en/
OPKO Health, Inc.
Steven D. Rubin, 305-575-4100
or
Adam
Logal, 305-575-4100
Source: OPKO Health, Inc.
Released June 9, 2015
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