#Biotech
#Stocks Snapshot – Fighting Deadly #Bacteria and #Coronavirus – (NASDAQ: $CTXR)
(NASDAQ: $INO) (NASDAQ: $NVAX),
(NYSE: $NNVC) (NASDAQ: $MRNA)
Point
Roberts WA, Delta BC – January 27, 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/01271FightingBacteriaViruses.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.
About Investorideas.com - News that
Inspires Big Investing Ideas Investorideas.com
is a recognized news source publishing third party news, research and original
financial content. Learn about investing in stocks and sector trends with our
news alerts, articles, podcasts and videos, looking at cannabis, crypto, AI and IoT, mining,
sports biotech, water, renewable energy and more. Investor Idea’s original
branded content includes the following podcasts and columns : Crypto
Corner , Play by Play
sports and stock news column, Investor
Ideas Potcasts Cannabis
News and Stocks on the Move podcast and column, Cleantech and Climate Change , Exploring Mining the AI Eye .
Disclaimer/Disclosure: Investorideas.com is a digital publisher of third party sourced news, articles
and equity research as well as creates original content, including video,
interviews and articles. Original content created by investorideas is protected
by copyright laws other than syndication rights. Our site does not make
recommendations for purchases or sale of stocks, services or products. Nothing
on our sites should be construed as an offer or solicitation to buy or sell
products or securities. All investing involves risk and possible losses. This
site is currently compensated for news publication and distribution, social
media and marketing, content creation and more. Disclosure is posted for each
compensated news release, content published /created if required but otherwise
the news was not compensated for and was published for the sole interest of our
readers and followers. Contact management and IR of each company directly
regarding specific questions. Disclosure: this news article featuring
CTXR is a paid for news release on Investorideas.com – third party (two
thousand) More disclaimer info: https://www.investorideas.com/About/Disclaimer.asp Learn more about publishing your news release and our other
news services on the Investorideas.com newswire https://www.investorideas.com/News-Upload/ and
tickertagstocknews.com
Global investors must adhere to regulations of each country.
Please read Investorideas.com privacy policy: https://www.investorideas.com/About/Private_Policy.asp
Contact
Investorideas.com
800-665-0411
