Why are we here? Worth a look. (courtesy of Biodoc and ROMAD Diver)
(from Romad Diver)I briefly mentioned a few days ago what I thought is missing here--understanding of what we have (and overunderstanding in some cases). We have a couple of First-In-Class products leading our company. How do we truly measure their successes and failures? What existing data do we have to compare our products with to properly define success and failure? Easy answers for Kevetrin may be something like tumor stabilization, tumor shrinkage, and/or restaging of the patients. Well, I dont see it being that simple because of the extremely broad range of...stuff...that p53 actually is responsible for (most we still don't know or fully understand). In this trial we may discover that K is great against cancer, but it may come at a cost that isn't worth it. We don't know because this is so new. As for those who study p53, they have a better idea of the true power K might hold, and they stay away from it because of what ifs. Genotoxicity is only a smal part of the equation.
After all that I have read on p53 and this company, I am here because of Kevetrin and believe it has it's place in the world. I knowingly take the risk that certain really nasty things might develop at an accelerated rates because of K. But maybe they don't! Too many unknowns in First-In-Classes for many to take a leap of faith on, but not me. I like high risk ventures.
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(from Biodoc)I am comfortable buying and holding CTIX because of Brilacidin. After two Phase 2 trials with 430 patients studied for ABSSSI, it is clear that the drug works. It treats most gram positive bacteria, limited gram negative bacteria and is outstanding against the tough-to-treat MRSA. Single dose regimens are comparable to best-in-class daptomycin and better than oft-used and nasty Vancomycin. Adverse effects with Brilacidin are relatively minor (paresthesias), time-limited, and manageable. Resistance is unlikely based on the mechanism of action. The Phase 2B study results with two single dose regimens and one 3 day regimen were all outstanding. Trial results were interestingly very close to what was predicted from modeling which to me is actually quite comforting. These results are not a fluke- Brilacidin is the real deal for treating ABSSSI. QIDP designation reduces costs and accelerates the development path. Unlike a cancer drug that can take years to move through trials, the study timeframe for an antibiotic is very short. Phase 2B enrolled and treated 215 patients in less than 9 months with only 4 study sites. The larger Phase 3 trial will not take much longer if there are more than 4 study sites. The data to date makes me extremely confident that Brilacidin for ABSSSI will advance through trials with results very similar to what we have seen in Phase 2. Cubicin sold for $9.5 billion for daptomycin and a modest pipeline. Is Brilacidin for ABSSSI worth less than $300MM at this stage of development? I don't think so.
Brilacidin has all the right properties for preventing/limiting oral mucositis. Anti-inflammatory, anti-bacterial, and anti-biofilm. Has anyone ever taken ibuprofen before a procedure and had minimal pain afterwards? Is anyone familiar with the effect of pre-operative/intra-operative anti-inflammatory steroids in limiting surgical pain? Consider pre-emptive pain strategies when thinking about how B_OM might work. Brilacidin has all the right properties to limit tissue injury and the trial design of starting the rinses before tissue injury and continuing beyond the treatment period is perfect. Obviously, I'm extremely optimistic. Also, oral mucositis impacts many, many patients. Cellceutix is targeting a very specific head/neck cancer population where almost everyone gets severe oral mucositis that adversely impacts treatment and greatly increases morbidity. Yes, you could say I'm optimistic and it won't take long to know if it really works.
I totally agree with ROMAD Diver that Kevetrin is extremely complex. We can outline specific mechanisms, various cytokine cascades, and some feedback loops but the bottom line is will it prove useful in fighting cancer? As a standalone, in combination, as a primer- I'm curious but I'm not sure it matters. If it's well tolerated and adds to our arsenal to battle cancer, it's worth a fortune. I agree that non-genotoxicity is not the whole story but it's a really good start if Kevetrin is effectively impacting tumors. As I've stated before, the very short half-life and the current dosing regimen for Phase 1 makes it more incredible to me that it has had any effect. IMO, we'll see the good stuff when it's given every other day. Of course, we might also see some bad stuff. We'll learn about both and hopefully, the benefit will greatly outweigh the risk.
I sleep well at night because of Brilacidin for ABSSSI. The anti-bacterial effectiveness is proven. B-OM is focusing on the anti-inflammatory properties of brilacidin and may be the first of many anti-inflammatory indications. Leo has addressed this but it seems to fall on many deaf ears.
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