Clinical-stage
biopharma company Cellceutix has been getting a lot of attention lately, thanks
in large part to their milestone successes developing what is arguably a
world-class drug portfolio pipeline. The company’s portfolio ranges from
dermatology and oncology, to a potentially game-changing class of wholly novel
antibiotics modeled on the human body’s own defense proteins.
The
company’s advancement of their lead antibiotic drug candidate, Brilacidin,
which was obtained alongside several other development candidates back in late
2013 when Cellceutix picked up the PolyMedix assets, has gone extremely well by
all accounts. Successful Phase 2b clinical trialing of Brilacidin in Acute
Bacterial Skin & Skin Structure Infections (ABSSSI), designed in conjunction
with the FDA, showed that a lower single-dose regimen of the drug was
well-tolerated and demonstrated comparable efficacy when compared to a 7-day
regimen of the active control, daptomycin.
Moreover,
Brilacidin’s unique mechanism of action, which works on both gram-positive and
gram-negative bacteria, as well as drug-resistant bacteria like MRSA
(Methicillin-resistant Staphylococcus aureus) and VRE (Vancomycin-resistant
enterococci), indicates the drug’s immense potential in helping to address an
increasingly critical need for antibiotics that can offset adaptive resistance
among dangerous bacteria. The rising threat of multi-drug resistant bacteria,
which are linked to some 23k deaths and over two million infections each year
in the U.S. alone, has even promoted some in the scientific community to argue
that we are approaching the end of standard antibiotics as we know it. The
overuse and misuse of antibiotics is fueling the rapid evolution of bacteria
towards a potential nightmare scenario and some bacteria has already developed
a strong or even unassailable resistance to common antibiotic classes like
penicillins and cephalosporins. The handwriting is on the wall and the demand
for novel antibiotics that can circumvent bacterial adaptation with innovative
mechanisms of action will steadily increase as the problem mounts.
This
ominous problem has even driven the Obama Administration to recently seek some
$1.2 billion to address the issue as part of the fiscal 2016 budget. This
strong move by the current administration would nearly double last year’s
federal spending on efforts to address such superbugs, channeling $650 million
to the NIH and BARDA (Biomedical Advanced Research and Development Authority)
in order to speed up the development of new antibiotics that can cope with
resistant bacteria, antibiotics just like Brilacidin. Under this proposal, $280
million would also go to the CDC just to shore up monitoring antibiotic use and
resistance, with the VA and DOD getting around $160 million combined to go
after antibiotic-resistant infections in health care settings.
The
landmark 21st Century Cures Initiative legislation put forth in the U.S. House
Energy and Commerce Committee recently would bring in major changes to the FDA
as well, effectively streamlining the process for inventing new medicines, as
well as finding new uses for older ones. Designed to sheer-off a huge chunk of
the roughly $2.6 billion it costs to develop a new medicine these days (a
nearly three-fold increase of the cost around a decade ago), this new
legislation also seeks to help address problems like the rise of drug-resistant
bacteria by clearing the decks for pharmaceutical innovation. The research put
forth by Deloitte and Thomson Reuters in 2013 says it all, with twelve of the biggest
R&D budgeted pharma developers spending around $1.3 billion to bring a new
drug to market and peak sales declining on a per-asset basis by about 43%, a
noticeable crisis has formed in the market when it comes to the development of
new drugs.
This
is where a drug like Brilacidin, the lead candidate of an entirely new class of
antibiotics called defensin-mimetics, comes into play, as Brilacidin’s unique
mechanism of action actually penetrates the cell wall of bacteria, making
adaptation highly unlikely. Brilacidin is modeled directly on the body’s own
host defense proteins and has even been shown to have distinct
anti-inflammatory, as well as anti-biofilm properties during Phase 2b testing.
Facts which will be highlighted this April 25 through 28 at the European
Congress of Clinical Microbiology and Infectious Diseases in Copenhagen, when
CTIX’s CMO, Dr. Daniel Jorgensen, walks attendees through the ABSSSI trial’s
clinical data, as well as some choice preclinical data.
Cellceutix
has a variety of specialized Brilacidin indications currently in the works,
like Brilacidin-Ocular for eye infections and Brilacidin-Otic for ear
infections, and the company’s defensin-mimetic compounds have generally shown
low toxicity in mammalian cells during laboratory studies funded via government
grants, while simultaneously showing solid activity against a host of the most
problematic pathogens. The capacity of the company’s novel defensin-mimetic
compounds to battle infection, while acting as both a tissue healer and anti-inflammatory,
looks to have tremendous potential for treating a vast array of
gastrointestinal diseases and the company has even recently submitted a request
to the FDA to do a pre-IND meeting on the subject. CTIX sees a huge market
emerging for their defensin-mimetic compounds in the treatment of ulcerative
colitis, the global market for which was forecast last year by GlobalData as
being on track to hit $6.6 billion by 2022, on a CAGR of 4.7%. With over half
of that sizeable market coming from just the U.S., and the additional potential
for these compounds to cover significant territory in other diseases of the GI
tract like Crohn’s disease, Cellceutix’s defensin-mimetic franchise likely has
a very bright future indeed.
On
the cancer front, Cellceutix is continuing their work in Kevetrin™, a novel
small-molecule compound with a highly unique structure that sets it apart from
other anti-cancer agents on the market today. Noteworthiness that is reinforced
by the drug’s consistently solid good-or-better activity when compared to
standard chemotherapies across an entire range of different cancer cell lines.
Kevetrin’s apparent ability to handle multiple types of cancer could make
CTIX’s oncology pipeline a strong money maker for the company and there have been
some extremely encouraging results thus far to reinforce this outlook.
The
report earlier this year, which specified a patient enrolled in the company’s
Phase 1 clinical trial of Kevetrin in ovarian cancer at Harvard Cancer Center’s
Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center showed an
almost total disappearance of a metastatic spleen lesion as well as markedly
reduced peritoneal fluid during three-dose cycle treatments, is a glowing
endorsement for the drug’s apparent anti-cancer properties. The fact that a
serious lesion became essentially undetectable in a patient with Stage 4
ovarian cancer after completing the second and third cycles of treatment, and
that the patient’s disease subsequently was classified as being in a clinically
stable condition, roundly verifies Kevetrin’s ability to circumvent cancer cell
drug resistance, one of the leading reasons most that most cancer treatments
fail.
Increased
levels of the key biomarker p21 in patient’s peripheral blood cells during the
study firmly suggest that Kevetrin is helping p53, the so-called guardian angel
gene, to reestablish its role as a tumor suppressor, given that p21 is a
notable downstream target of activated p53. Perhaps more importantly, ongoing
research at the hospital is lending credence to the idea that Kevetrin’s
efficacy ceiling is dosage-related, meaning that higher dosages could indeed
provide an answer for hard to treat diseases like metastatic ovarian cancer.
This would be another big market for CTIX, as the American Cancer Society
currently estimates that in the U.S. this year alone, more than 21k women will
be diagnosed with ovarian cancer and that tragically more than 14k women will
die from it.
Given
that the principal investigators in the ovarian cancer trial have urged
Cellceutix to put together a presentation on the safety and pharmacology of
Kevetrin in multiple cancer cell lines, the drug could go way beyond a
successful trial and rapidly develop into a leading broad-spectrum anti-cancer
indication. When you stack this up against the company’s other oncology
indication, Brilacidin-OM, whose defensin-mimetic properties have been shown in
laboratory studies to slash ulcerative oral mucositis occurrences by a whopping
94%, the oncology pipeline at CTIX starts to look like a real winner, with
far-reaching implications when it comes to future treatments and further
development options.
The
final drug candidate in Cellceutix’s arsenal is a dermatology indication for
treating psoriasis. A small-molecule immune modulator named Prurisol™ (abacavir
acetate), which is being developed under an FDA-recommended 505(b)(2)
designation, whose active component, abacavir, is already well-documented as an
FDA-approved HIV/AIDS treatment. With Phase 2 clearance secured for Prurisol
and successful Phase 1 clinical trial data in animal models showing the drug
converts readily to abacavir, and that the drug is effective against psoriasis,
Phase 2/3 trialing will largely be focused on validating this same conversion
in humans and clearing the way for eventual commercialization.
For
more information, visit www.Cellceutix.com
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