#BioPharma
#Stocks Making the Headlines fighting #Coronavirus and #Bacteria - (NASDAQ: $CTXR)
(NASDAQ: $INO) (NASDAQ: $NVAX), (NYSE: $NNVC) (NASDAQ: $MRNA)
Point
Roberts WA, Delta BC – January 28, 2020 - Investorideas.com, a leading
investor news resource covering pharmaceutical and biotechnology stocks
releases a special report on the opportunity within the specialty drug segment
of the sector to address viral outbreaks and bacterial resistance, featuring Citius Pharmaceuticals, Inc. (NASDAQ: CTXR).
Certain
social and technological advancements as well as new and deadlier viral
(coronavirus) and bacterial outbreaks are forcing innovative business
approaches for this competitive sub-sector and specialty companies are
answering the call!
Read this news
featuring CTXR in full at https://www.investorideas.com/news/2020/biotech/01281FightingCoronavirusBacteria.asp
Looking
at the current headline attention of the coronavirus, Infectioncontroltoday.com
also addressed the current crisis of antimicrobial resistance. “Now that the
planet’s attention is turned toward infectious disease thanks to the spotting
of coronavirus in the United States, the World Health Organization (WHO) took
the opportunity to point to another problem: the growing shortage of
antibiotics available to fight all pathogens.”
A
WHO press release reported, ”Tedros
Adhanom Ghebreyesus, PhD, the director-general of WHO, said in the press
release that “never has the threat of antimicrobial resistance been more
immediate and the need for solutions more urgent. Numerous initiatives are
underway to reduce resistance, but we also need countries and the
pharmaceutical industry to step up and contribute with sustainable funding and
innovative new medicines.”
Citius Pharmaceuticals, Inc. (NASDAQ: CTXR), a specialty
pharmaceutical company focused on adjunctive cancer care and critical care drug
products is in the midst of bringing their products to market having recently
announced
a positive outcome of the pre-specified interim futility analysis for the Phase
3 clinical trial of Mino-Lok® vs. standard-of-care antibiotic locks.
The
analysis was conducted by the Mino-Lok trial Data Monitoring Committee
("DMC"), an independent panel of experts charged with periodically
monitoring the safety and efficacy of the progress of the pivotal trial. The
Company reached and completed the pre-specified 40% enrollment required for the
interim futility analysis in late September and, based on the analysis of the
data and recommendations of the DMC, will proceed with the current trial as
planned. Topline data from the superior efficacy interim analysis, the next
major milestone in the Mino-Lok trial, is expected in the first half of
2020. The market potential for an
effective antibiotic lock therapy is estimated at $750 million per year in the
US and approximately $1.5 billion per year worldwide.
"We
are extremely happy and proud that the first independent expert review of the
patient data in our Mino-Lok trial concludes that our study is on track.
Enrollment has continued since finalizing the 40% level futility report, and we
have now reached the midpoint of our study. The DMC will evaluate clinical data
at the 75% level of enrollment to see if Mino-Lok demonstrates superior
efficacy versus standard-of-care antibiotic locks," said Myron Holubiak,
Chief Executive Officer of Citius. "We would also like to thank all of the
patients, study investigators, and support personnel at the 32 clinical sites
that are participating in our trial. Lastly, we also want to acknowledge the
research and guidance of Dr. Issam Raad and his team at MD Anderson Cancer
Center in advancing this novel therapy."
Citius
Pharmaceuticals, Inc. “Saving Lives of Hospital Patients with Catheters
Infected by Deadly Bacteria” :
Citius was recently
featured in a recent edition of BiotechStock Review, which discussed the Citius “Mino-Lok”
treatment - “created to kill infected catheters, Mino-Lok was developed
clinicians and technologists at the M.D. Anderson Cancer Center. The Mini-Lok
technology while complex is easy for investors to understand. Their market is
huge, estimated at $500 million to $1 billion annually and fairly-easy for
investors to identify. The need for Mino-Lok is rather obvious as we will later
explain. Also, studies to date have proven it to be much safer, more effective
and less expensive than the alternatives and once again, easy for investors to
grasp. Finally, the time (they’re in Phase III), path and cost to approval are
modest in comparison to biotech companies creating drugs from scratch. A
‘five-fecta’ so to speak.”
Continued: “Part of the
Citius business strategy is to build a successful company by developing and
commercializing cost-effective products that address unmet medical
needs. It seeks to leverage the FDA’s 505(b)(2) pathway for new drug approvals
and bring products to market faster and with lower cost than other FDA
new drug approval pathways (meaning creating drugs from scratch).“
Continued “The Mino-Lok
solution was created to kill bacteria that cannot be eradicated using
current methods, resulting in the catheter needing to be removed and replaced.
A dangerous and complicated procedure, Mino-Lok is the first – and only –
therapy under investigation that can be used to sterilize and save the infected
catheter.”
Continued “Mino-Lok is a patented solution that combines
Minocycline, an antibiotic from the Tetracycline family with two other
well-known ingredients. Minocycline was patented around the time we were born,
as in 60 years ago – and prescribed 2 million times last year. It’s now a
generic costing about $12 a dose. The list of use includes things like Anthrax
and even the Bubonic Plague. So were guessing the FDA will recognize both its
usefulness and safety profile.”
Fusionscienceacademy.com
reports, “According to the
Centers for Disease Control and Prevention (CDC), the leading federal agency
focused on public health in the United States, over two million infections are
caused by the antibiotic-resistant bacterial pathogens per year in the country,
resulting in around 23,000 deaths.”
Inovio Pharmaceuticals, Inc. (NASDAQ:INO) has seen
opportunity in a viral disaster, having recently
announced
the Coalition for Epidemic Preparedness Innovations (CEPI) has awarded Inovio a
grant of up to $9 million to develop a vaccine against the recently emerged
strain of coronavirus (2019-nCoV). This initial CEPI funding will support
Inovio's preclinical and clinical development through Phase 1 human testing of
INO-4800, its new coronavirus vaccine matched to the outbreak strain. CEPI
previously awarded Inovio a grant of up to $56 million for the development of
vaccines against Lassa fever and Middle East Respiratory Syndrome (MERS), also
caused by a coronavirus.
Inovio's
participation in this developing effort is based on the ideal suitability of
its DNA medicine platform to rapidly develop a vaccine against an emerging
virus with pandemic potential, proven vaccine development capabilities and a
strong track record of rapidly generating promising countermeasures against
previous pandemic threats. Inovio was the first to advance its vaccine
(INO-4700) against MERS-CoV, a related coronavirus, into evaluation in humans.
Inovio is currently preparing to initiate a Phase 2 vaccine trial for INO-4700 in
the Middle East where most MERS viral outbreaks have occurred.
In
a recently published paper in Lancet Infectious Diseases, Inovio's Phase 1
study of its MERS-CoV vaccine demonstrated it was well tolerated and
furthermore induced high levels of antibody responses in roughly 95% of
subjects, while also generating broad-based T cell responses in nearly 90% of
study participants. Durable antibody responses to INO-4700 were also maintained
through 60 weeks following dosing.
Richard
Hatchett, CEPI's CEO said, "Given the rapid global spread of the 2019-nCoV
virus the world needs to act quickly and in unity to tackle this disease. Our
intention with this work is to leverage our work with Inovio on the MERS
coronavirus and rapid response platform to speed up vaccine development."
Dr.
J. Joseph Kim, Inovio's President and CEO said, "We're extremely honored
to expand our partnership with CEPI to tackle this new threat to global public
health. Our DNA medicine platform represents the best modern day approach to combatting
emerging pandemics. We have already demonstrated positive clinical outcomes
with our vaccine against MERS-CoV, another coronavirus. Importantly, following
the Zika viral infection outbreak, Inovio and our partners developed a vaccine
that went from bench to human testing in just seven months – the fastest
vaccine development on record in recent decades. We believe we can further
improve upon this accelerated timeline to meet the current challenge of the
emerging coronavirus 2019-nCoV."
Talking
about stocks moving on potential vaccines for the Coronavirus, Zacks Research reported “Obviously, shares
of vaccine manufacturers have gained sharply on concerns over the new virus.
Novavax, Inc. (NASDAQ: NVAX), a late-stage
biotechnology company, saw its shares soar 72% on Jan 21. The company is
primarily manufacturing two late-stage vaccines for the flu and various other
infectious diseases. Another nano-biopharmaceutical company, NanoViricides,
Inc. NNVC (NYSE: NNVC) witnessed its
shares climb more than 100%. After all, the company is known for developing
nano-medicines for viral diseases like swine and bird influenza.”
Another
specialty biotech company, Moderna, Inc. (NASDAQ: MRNA) is developing
therapeutics and vaccines for infectious diseases, immuno-oncology, rare
diseases, cardiovascular diseases, and autoimmune and inflammatory diseases,
independently and with strategic collaborators.
Moderna
just announced a new
collaboration to develop an mRNA vaccine against the novel coronavirus
(2019-nCoV).
From
the news: Under the terms of the agreement, Moderna will manufacture an mRNA
vaccine against 2019-nCoV, which will be funded by CEPI. The Vaccine Research
Center (VRC) of the National Institute of Allergy and Infectious Diseases
(NIAID), part of NIH, collaborated with Moderna to design the vaccine. NIAID
will conduct IND-enabling studies and a Phase 1 clinical study in the US.
From
the news: Over the past four years Moderna has had six positive Phase 1
clinical readouts in its prophylactic vaccines modality and moved two
additional programs into development. Moderna’s technology platform, fully integrated
manufacturing site and development experience, combined with a multi-year
relationship with the NIH, including exploring ways to respond to public health
threats, allows for the rapid identification and advancement of a vaccine
candidate against 2019-nCoV.
With
antibiotic-resistant bacteria on the rise and new strains of viruses surfacing,
opportunity abounds for the smaller specialty drug maker that can provide
solutions.
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