Innovation Pharmaceuticals Inc (IPIX)

[TOB]

Cellceutix may achieve a second valuable QIDP designation for for Klebsiella Pneumoniae for defensin mimetic compound CTIX 1278 based upon government funded research being conducted at a major university in Texas.

[Long post, scroll down for all content -TOB]

Study Shows Cellceutix Antibiotic Active Against Drug-Resistant Superbug Klebsiella Pneumoniae

Klebsiella Pneumoniae Is One of the World’s Most Dangerous Superbugs as Some Strains Are Known to Be Resistant to Virtually Every Antibiotic Available Today

BEVERLY, MA–(Marketwired – Apr 14, 2014) – Cellceutix Corporation (OTCQB: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, is pleased to report favorable results in a recently completed preclinical study evaluating its novel antibiotic compounds against specific strains of multi-drug resistant Klebsiella pneumoniae. The research, which is government funded through existing grants to research institutions, is being conducted at a major university in Texas.

In a thigh burden study of a multi-drug resistant strain of Klebsiella pneumoniae in a mouse model, Cellceutix’s defensin mimetic compound CTIX1278, was efficacious as compared to a carbapenem antibiotic that is widely used as a last line of defense against drug-resistant, Gram-negative bacteria, including Klebsiella pneumoniae. A second study is now being conducted at multiple dosing levels with various infusion parameters with the goal of increasing efficacy and further defining a treatment protocol for the compound.

“This is highly encouraging early data of CTIX1278 as it is the first example of efficacy in vivo with one of our defensin mimetic compounds versus Klebsiella pneumoniae,” comments Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. ”A Gram-negative bacteria, Klebsiella pneumoniae is one of the world’s most dangerous superbugs; strains of this bacteria are rapidly emerging that are resistant to virtually every antibiotic available today. The world is staring down the barrel at a growing number of bacteria that can’t be killed by available drugs and the last line of defense is wearing thin. We are very pleased with this latest study providing another piece of evidence that our defensin mimetics have the potential to introduce the first new class of antibiotic drugs in more than two decades to combat the growing problem of antibiotic resistance.”

As it conducts the second study for Klebsiella pneumoniae, the university is awaiting additional materials to begin in vivo research in models of superficial and deep tissue wounds. In these studies, infecting organisms include Gram-negative multi-drug resistant Pseudomonas aeruginosa and Acinetobacter baumannii. This research is also being funded through existing government grants.

Thus Cellceutix could receive a third and fourth valuable Qualified Infectious Disease Product (QIDP) designation under the GAIN Act as the bacteria Acinetobacter and Pseudomonas are also on the list of qualifying pathogens.

Link to Full Law

Excerpt:

(f) QUALIFYING PATHOGEN.— [for QIDP designation]

‘‘(1) DEFINITION.—In this section, the term ‘qualifying
pathogen’ means a pathogen identified and listed by the Secretary
under paragraph (2) that has the potential to pose a
serious threat to public health, such as—

‘‘(A) resistant gram positive pathogens, including
methicillin-resistant Staphylococcus aureus, vancomycinresistant
Staphylococcus aureus, and vancomycin-resistant
enterococcus;

‘‘(B) multi-drug resistant gram negative bacteria,
including Acinetobacter, Klebsiella, Pseudomonas, and E.
coli species;

Drug-resistant Klebsiella

Some Klebsiella bacteria have become highly resistant to antibiotics. When bacteria such as Klebsiella pneumoniae produce an enzyme known as a carbapenemase (referred to as KPC-producing organisms), then the class of antibiotics called carbapenems will not work to kill the bacteria and treat the infection. Klebsiella species are examples of Enterobacteriaceae, a normal part of the human gut bacteria, that can become carbapenem-resistant.

CRE, which stands for carbapenem-resistant Enterobacteriaceae, are a family of germs that are difficult to treat because they have high levels of resistance to antibiotics. Unfortunately, carbapenem antibiotics often are the last line of defense against Gram-negative infections that are resistant to other antibiotics. -Link to CDC

This is big, potentially much more important for humanity than the ABSSSI antibiotic. Recall Cellceutix's Chief Scientific Officer Dr. Menon's excitement when talking about the pre-clinical tests showing efficacy against Klebsiella Pneumoniae during the Cox video interview. -Link to Video interview.

Interview: Cellceutix Executives Dr Menon & Mr Leo Ehrlich by Patrick Cox

Note: This interview was released prior to the end of the Brilacidin P2b trial and the announcement of Positive Top-Line Data. Dr Menon can be heard expressing his confidence in the trials pending success, which indeed occurred.

At 7.17 minute mark in the video, Dr Menon talks about the research they doing on Drug-Resistant Superbug Klebsiella Pneumoniae.

WASHINGTON — Over six frightening months, a deadly germ untreatable by most antibiotics spread in the nation's leading research hospital. Pretty soon, a patient a week was catching the bug. Scientists at the National Institutes of Health locked down patients, cleaned with bleach, even ripped out plumbing – and still the germ persisted.

By the end, 18 people harbored the dangerous germ, and six died of bloodstream infections from it. Another five made it through the outbreak only to die from the diseases that brought them to NIH's world-famous campus in the first place.

It took gene detectives teasing apart the bacteria's DNA to solve the germ's wily spread, a CSI-like saga with lessons for hospitals everywhere as they struggle to contain the growing threat of superbugs.

It all stemmed from a single patient carrying a fairly new superbug known as KPC – Klebsiella pneumoniae that resists treatment by one of the last lines of defense, antibiotics called carbapenems.

How Scientists Stopped Klebsiella Pneumoniae: Deadly Superbug Killed 6 At NIH Clinical Center

[Cellceutix Website]

Gram Negative Bacteria

The Company [Cellceutix] is focusing this research on some of the most difficult to treat multi-drug resistant or “pandrug-resistant” bacterium where there is a significant and growing medical need for new therapies. Cellceutix’s researchers have identified a series of host defense protein (HDP)-mimetic compounds that rapidly kill a variety of clinically-important Gram-negative pathogens. Infections caused by these pathogens are very difficult to treat because the bacteria are typically multi-drug resistant, which can lead to life-threatening conditions. The Company’s compounds are active against some of the most problematic pathogens, such as Pseudomonas aeruginosa, Klebsiella pneumoniae, Escherichia coli and Acinetobacter baumannii as well as highly multi-drug resistant ndm-1-producing K. pneumoniae. In laboratory studies being funded through government grants the Company’s compounds exhibited low toxicity against mammalian cell types.

Klebsiella pneumonia

In a thigh burden study of multi-drug resistant strain of Klebsiella pneumoniae in a mouse model, our defensin mimetic-compound CTIX-1278 was efficacious as compared to a carbapenem antibiotic that is widely used as a last line of defense against drug-resistant, Gram-negative bacteria. A second study is now being conducted at multiple dosing levels with various dosing parameters with the goal of increasing efficacy and further defining a treatment protocol for the compound. -Link to CTIX website page

CTIX Cellceutix: The Best Is Yet To Come™