Innovation Pharmaceuticals Inc (IPIX)

[Waverunner1]

not much of a spoiler in reality as both of those drugs have half-life issues with significant ramifications...

The duration of action of a drug is known as its half-life. It's the period of time it takes for the concentration of the drug to be reduced by one-half, usually measured by the amount of the drug in plasma. It's logical that the dosing regimen of Dalvance was set at a one week increment because of its "long elimination half-life" of approximately 204 hours (8.5 days), meaning that one dose didn't completely kill the bacteria and systemic toxicity was a problem any time sooner than a second dose before the eighth day. Orbactiv has a half-life of a glaring 14 days, which certainly has the potential of complications for patients who are generally quite sick and often require additional medications. It's this long half-life that was probably the culprit in The Medicines Company not finding a suitor to partner in development or commercialization. It's also the reason that physicians may be reluctant to prescribe the drug.

Comparator Arms for Dalvance and Orbactiv Lacked Muscle

While Durata and The Medicine Company selected vancomycin, a generic antibiotic with a growing resistance issue, as the comparator drug in their trials, Cellceutix selected the Cubist blockbuster daptomycin (Cubicin), considered a superior drug to vancomycin, as its comparator. In the trial, Brilacidin is being administered as a single-dose regimen and a three-day regimen versus the standard seven-day therapy daptomycin. In antibiotic clinical trials, experimental drugs are measured as "not inferior to" the approved drug. If Brilacidin hits this point of comparison to daptomycin in any dosing scheme (especially a single dose), while demonstrating the drug to be safe and well tolerated, it will be a milestone moment, not only for Cellceutix, but also for antibiotics. The double-blind trial will be completed this month and no serious drug-related adverse events have been reported to date, based upon Cellceutix updates. If the data is positive, it's presumable that Brilacidin will qualify for expedited review programs as it positions for a pivotal Phase 3 trial, much like Dalvance and Sivextro did.

Cellceutix has not missed a beat in recognizing the half-life issues with Dalvance and Orbactiv. Its chief executive officer (Ehrlich) noted in a press release on Monday, "This means that the drug remains in a patient's system for a considerable period following dosing, which has the potential for contraindication with other medicines and questions concerning metabolism and drug resistance." Ehrlich noted that Brilacidin only has a half-life of 13-16 hours, which the company believes is an "ideal" half-life for efficacious treatment without running the risk of resistance developing.

Brilacidin also seems to have the potential to treat infections of broader scope that the aforementioned drugs. Prior research suggests that it can be effective against Gram-positive and Gram-negative infections, including drug-sensitive and drug-resistant strains, such as MRSA and VRE (resistant to vancomycin). Additionally, Cellceutix has said it intends to pursue ear and eye infections, as well as diabetic foot ulcer infections now that Brilacidin has been formulated to be stable at room temperature.

A single-treatment drug with a good safety profile that squashes concerns of patient compliance and odds of drug resistance forming would be the dream drug. While all the drugs mentioned are a absolutely a step up from what the antibiotic landscape looked like a year ago, only one company meets that possibility, Cellceutix.

http://seekingalpha.com/article/2422945-did-the-medicines-company-trump-cellceutix-and-others-in-a-1b-plus-skin-infection-market?page=2