NEW YORK, October 3, 2016 /PRNewswire/ --
Performing clinical trials is an essential research tool for
progressing medical awareness and patient care. Clinical research
is complete only if doctors aren't sure whether a brand new method
works well on individuals and is harmless and which treatments or
approaches work best for valid infections or groups of people. If
clinical trials are to be successful, it is crucial that more
people participate. Citius Pharmaceuticals Inc.
(OTCQB: CTXR), Tobira Therapeutics
Inc. (NASDAQ: TBRA), Arrowhead
Pharmaceuticals Inc. (NASDAQ: ARWR), Dicerna
Pharmaceuticals Inc. (NASDAQ: DRNA), Catabasis
Pharmaceuticals Inc. (NASDAQ: CATB).
Citius Pharmaceuticals Inc. (OTCQB: CTXR)
announced recently that it has begun the essential Phase 3 clinical
trial of their product, Mino-Lok™. Mino-Lok is an alternative to
eliminating and substituting central venous catheters (CVCs). Of
nearly 7 million CVCs handled annually, around 7% become tainted
leading to life threatening infections known as catheter-related
blood stream infections (CRBSIs). Combining Mino-Lok with suitable
universal antibiotics, is used to retain central venous access and
dodge the difficulties connected with catheter abstraction and
replacement.
Citius Pharmaceuticals Inc. (CTXR) Phase 3 trial is a
multi-center, randomized, double-blind study of approximately 700
patients to discover the effectiveness and wellbeing of Mino-Lok
Therapy, a novel antibiotic lock therapy that syndicates
minocycline with edetate disodium in 25% ethanol solution. The key
endpoint is the amount of substantial percentage of subjects
gaining total success in upholding the treated CVCs at the test of
treatment at week 8. Secondary endpoints is the wellbeing and
acceptability as defined by opposing events, serious adverse events
(SAEs), critical indications, clinical laboratory calculations, and
physical analyses. Phase 3 clinical trial is likely to take 2 years
to complete. The first patient is anticipated to be registered in
early 2017. Medpace has been selected as the trial
administration clinical research organization. President and Chief
Executive Officer, Mr. Myron
Holubiak commented, "This is a major milestone for Citius as
our lead product is entering registration trials. Mino-Lok has the
potential to become a standard of care (SOC) for treating
CRBSIs."
Another biopharmaceutical company that also focuses on research
and development of therapies, Tobira Therapeutics Inc.
(NASDAQ: TBRA) has initiated Phase 1 research against
non-alcoholic steatohepatitis (NASH) and other liver related
diseases by combining the company's product candidate, cenicriviroc
with evogliptin. Tobira believes that patients with NASH will
benefit the most from its therapies, tackling several mechanisms.
The statistics produced in its CENTAUR Phase 2b research confirmed
that cenicriviroc has strong and tolerable anti-fibrotic activity.
The anti-fibrotic mechanism of cenicriviroc delivers a concrete
support to which metabolically-targeted agents such as evogliptin
can be added, thus combining cenicriviroc and evogliptin could be
effective to address several drivers of NASH.
Clinical-stage RNA interference therapeutics
company, Arrowhead Pharmaceuticals Inc. (NASDAQ:
ARWR) publicized collaboration with biopharmaceutical giant,
Amgen to develop and possibly commercialize two of Arrowhead's
experimental cardiovascular therapies. Amgen settled to a global
license for Arrowhead's RNAi ARC-LPA database intended as a novel
treatment for elevated lipoprotein (a), a danger factor for
atherosclerotic cardiovascular disease. In a separate deal, Amgen
will too obtain an opportunity for a global license to an RNAi
therapy indicated for undisclosed cardiovascular target. Amgen will
be accountable for the clinical development and commercialization
of both experimental therapies.
Dicerna Pharmaceuticals Inc. (NASDAQ: DRNA) had announced
that the Company will center its main focus on its proprietary
GalXCTM technology platform to advance progress of product
candidates in its core therapeutic areas of rare diseases, chronic
liver diseases, cardiovascular disease and viral infectious
diseases. Under this plan, Dicerna will transition its primary
hyperoxaluria (PH) development program to focus on DCR-PHXC, a
subcutaneously delivered GalXC clinical candidate, which was
announced earlier this year.
Catabasis Pharmaceuticals Inc. (NASDAQ: CATB) and Sarepta
Therapeutics, Inc. a commercial-stage developer of innovative
RNA-targeted therapeutics, has collaborated to explore a
combination drug treatment approach for Duchenne muscular dystrophy
(DMD). The two companies will contribute their respective expertise
to study an exon skipping treatment developed by Sarepta, together
with an oral NF-kB inhibition treatment developed by Catabasis in a
mouse model of DMD.
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