Innovation Pharmaceuticals Inc (IPIX)

[georgejjl]

A question for everyone.

If Brilacidin was the only drug in the Cellceutix pipeline, then honestly how much should Cellceutix be worth?

Cellceutix market capitalization is about $342 million with 114 million shares outstanding.

How much should Cellceutix be worth from Brilacidin alone?

"...Last month, we completed a Phase 2b Trial of Brilacidin for Acute Bacterial Skin and Skin Structure Infections (ABSSSI). The trial was a 215-patient blinded study, with four treatment arms comprised of approximately 50-55 patients per arm. Three of the arms were treated with Brilacidin (two single-dose arms and one 3-day regimen) and the fourth arm was treated with daptomycin in FDA-approved dosing regimen. Incidentally, daptomycin is a drug marketed by Cubist Pharmaceuticals under the brand name Cubicin. Cubicin sales in the first half of 2014 totaled $447 million, so it is a more than formidable comparator. Relative to a similar, previously completed Phase 2a trial, a lower total dose of Brilacidin was used in each of the three Brilacidin dosing arms.

We are awaiting the top-line data from the trial, which is expected in October/November. Preliminary information derived from the blinded data, which is not specific to any particular treatment as it is an aggregate of all four treatment arms, showed that by Day 7 the average cure rate was higher than what was observed in the prior Phase 2a study and similar to, if not higher than, cure rates reported for other commonly used ABSSSI drugs, as well as drugs approved by the FDA this year. Staphylococcus aureus (including Methicillin-resistant Staphylococcus aureus, or MRSA) was the most common bacteria isolated at the baseline visit. A single “possible” treatment-related serious adverse event (SAEs) was reported, but no other serious adverse events were reported in the trial, which we believe should effectively silence any critics who questioned the safety of Brilacidin.

Because approximately 160 of the 215 patients in the trial were treated with Brilacidin, the cure rate data was heavily influenced by Brilacidin. Further, the fact that half of the patients received only a single dose of Brilacidin and the overall cure rates improved from the earlier trial leaves us very optimistic about receiving favorable top-line results in a few months. If these data hold up, a single-dose regimen of Brilacidin would be included in our pivotal Phase 3 study designs.

We have extensively studied Brilacidin as a new treatment for diabetic foot ulcer infections, an area where we see a tremendous market opportunity in light of the exploding diabetes epidemic that has the International Diabetes Federation projecting 552 million people worldwide to have diabetes by 2030. There are limited treatments and currently no FDA-approved topical creams for the more than 1 million patients suffering from mild or moderate to diabetic foot infections each year. Our plan is to develop a combination Brilacidin treatment consisting of systemic and topical treatment. We are awaiting additional stability data and then will be ready to set up a meeting with the FDA to discuss the clinical pathway.

Also in our antibiotic/antifungal portfolio, we are actively testing several of our compounds both in house and through research grants at major universities. In the Gram-negative program, our lead compounds are active in laboratory testing against some of the most problematic pathogens, such as Pseudomonas, Klebsiella, E. coli and Acinetobacter. We have compounds active against drug-susceptible strains as well as multi-drug resistant strains that produce the Klebsiella pneumoniae carbapenamase (KPC) that confer resistance against other widely used antibiotics. Importantly, neither of these drug-resistance enzymes is active against our defensin mimetics. We expect to advance a Gram-negative drug into toxicology studies and file an IND for clinical development in 2015...."

- See more at: http://cellceutix.com/best-yet-to-come/#sthash.oAkT6bzQ.dpuf

"...Our Future

Realistically, it is difficult to cover each and every development in our pipeline in this letter. Brilacidin continues to impress and amaze us for all the different indications it seems to have potential to treat. Lab studies have demonstrated its broad activity against Gram-positive, Gram-negative and drug-resistant clinical isolate strains of eye infections. Other animal studies have shown Brilacidin to be effective it treating middle ear infections, including those caused by MRSA, where today’s approved drugs have been less-than-optimal in effect. We are extremely excited about the recent work at our labs to treat Chronic Obstructive Pulmonary Disease (COPD) with our compounds. COPD is the third leading cause of death in the U.S. and the market is tremendous, considering just GlaxoSmithKline’s Advair that hauled in $8.25 billion in sales in 2013.

The facts are that our team is stronger than ever; our clinical pipeline is moving into mid-to-late stages; we have incredible support through collaborations and partnerships with leading scientists and universities; we have more cash on hand or available than ever before; and we still run at an extremely low burn rate through prudent management of funds. If it sounds as if I am excited, it is because I am. I thank all of our loyal shareholders and look forward to another exciting year at Cellceutix.

The best is yet to come,

Leo Ehrlich
"

- See more at: http://cellceutix.com/best-yet-to-come/#sthash.oAkT6bzQ.qzjeImdF.dpuf

Good luck and GOD bless,

George