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georgejjl

08/13/17 3:55 PM

#193432 RE: biodoc #193431

Biodoc

I agree 100%. Leo et.al. have done and continue to do a wonderful job.

Good luck and GOD bless,

George
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F1ash

08/13/17 4:06 PM

#193433 RE: biodoc #193431

The interim results were fantastic and, imo, results were adversely skewed by a single nonresponder. I'm betting that topline results will be as good or better than interim results.



I was just looking back through a recent slide deck. Dr. Sonis's OM mouse models have apparently been extremely accurate and predictive!

See the bottom left of slide 19

https://static1.squarespace.com/static/5715352e20c647639137f992/t/5874df3417bffc9c6c4f5956/1484054328584/2017Jan9+Cellceutix_Biotech+Showcase+Presentation+%28final+for+website%29.pdf




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rmzport

08/13/17 5:07 PM

#193437 RE: biodoc #193431

Indeed! A great summary of what has and is about to happen!
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DaubersUP

08/13/17 6:30 PM

#193442 RE: biodoc #193431

Really good understanding and well written. Thank you.
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Golfguru03

08/13/17 6:39 PM

#193443 RE: biodoc #193431

Very concise and accurate Doc and even the naysayers or "short" group can understand though that won't stop them...we All appreciate your posts and insights and we all (most) will have steak and eggs for breakfast with a mimosa one day soon.. :) thank you...mark
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sox040713

08/13/17 8:20 PM

#193454 RE: biodoc #193431

Excellent summary, biodoc! I think the increased enrollment pace (about 30-40 patients in five months) was mostly influenced by the encouraging interim result. Leo said there was a great deal of competition for OM patients. When patients decide to participate in a trial, their doctors will present them with a list of choices. The 7 out of 9 severe OM prevention definitely made the decision easy for them. This bodes well for Phase 3 enrollment if top-line data are positive as well.
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MinnieM

09/09/17 12:39 PM

#196216 RE: biodoc #193431

Fully agree with you here:


In Reply to 'biodoc'

Leo has done an outstanding job managing available resources while efficiently moving multiple clinical trials forward. For a small biotech, IPIX has an enviable pipeline that should handsomely reward investors. Some comments about the pipeline:

Brilacidin

Brilacidin- Oral mucositis
Accelerated enrollment and now full enrollment of the Phase 2 trial reflect (1) increasing number of clinical trial sites and (2) very positive interim results. Back-end loaded enrollment after interim results is very positive. People forget that the enrollment criteria for this trial was very stringent. We knew it would be slow going from the beginning. The tradeoff with the stringent enrollment criteria and slow enrollment is that the targeted patient population is extremely likely to suffer from severe oral mucositis. The interim results were fantastic and, imo, results were adversely skewed by a single nonresponder. I'm betting that topline results will be as good or better than interim results.
Also, B-OM is a distinct formulation of Brilacidin that could easily be carved out of the Brilacidin franchise for partnering without compromising the Brilacidin franchise.

Brilacidin- ulcerative proctitis
Very positive results from a POC trial surely has Big Pharma attention. Perhaps by itself one could be skeptical of results but Brilacidin-OM data and pre-clinical data strongly supports Brilacidin's anti-inflammatory properties. With minimal GI absorption, technology is available to formulate Brilacidin for Crohn's and ulcerative colitis. It's known territory for Big Pharma.

B-ABSSSI: Phase 2b data is very strong and I am happy with Leo's decision to hold off on a very expensive Phase 3 trial while the Brilacidin franchise is further developed. I am confident that Brilacidin will prove superior to Vancomycin.

Kevetrin
: a short duration open label dose escalation trial focusing on biomarkers and safety potentially positions Kevetrin for partnering in the coming months. Is it safe? Does it appear to have a positive impact on biomarkers? Is there a clinical response with such a short duration of treatment and likely sub-optimal dosing?

Prurisol: The phase 2b trial is further exploring the dose/response relationship and is critical to knowing what we really have. The trial should be fully enrolled. We've discussed hoped for results at length in previous threads and results in the neighborhood of Otezla should give us a very lucrative deal.

Deals take time, negotiations are not publicized, and they don't usually occur in our imagined timeframes. One morning in the hopefully not too distant future we'll get some kind of deal. And then there will be another. And perhaps another.

I have full confidence in Leo and the IPIX team.

biodoc




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MinnieM

09/18/17 2:33 PM

#197428 RE: biodoc #193431

biodoc... good post I thought I'd bring up to the top.




In Reply to 'biodoc'

Leo has done an outstanding job managing available resources while efficiently moving multiple clinical trials forward. For a small biotech, IPIX has an enviable pipeline that should handsomely reward investors. Some comments about the pipeline:

Brilacidin

Brilacidin- Oral mucositis
Accelerated enrollment and now full enrollment of the Phase 2 trial reflect (1) increasing number of clinical trial sites and (2) very positive interim results. Back-end loaded enrollment after interim results is very positive. People forget that the enrollment criteria for this trial was very stringent. We knew it would be slow going from the beginning. The tradeoff with the stringent enrollment criteria and slow enrollment is that the targeted patient population is extremely likely to suffer from severe oral mucositis. The interim results were fantastic and, imo, results were adversely skewed by a single nonresponder. I'm betting that topline results will be as good or better than interim results.
Also, B-OM is a distinct formulation of Brilacidin that could easily be carved out of the Brilacidin franchise for partnering without compromising the Brilacidin franchise.

Brilacidin- ulcerative proctitis
Very positive results from a POC trial surely has Big Pharma attention. Perhaps by itself one could be skeptical of results but Brilacidin-OM data and pre-clinical data strongly supports Brilacidin's anti-inflammatory properties. With minimal GI absorption, technology is available to formulate Brilacidin for Crohn's and ulcerative colitis. It's known territory for Big Pharma.

B-ABSSSI: Phase 2b data is very strong and I am happy with Leo's decision to hold off on a very expensive Phase 3 trial while the Brilacidin franchise is further developed. I am confident that Brilacidin will prove superior to Vancomycin.

Kevetrin: a short duration open label dose escalation trial focusing on biomarkers and safety potentially positions Kevetrin for partnering in the coming months. Is it safe? Does it appear to have a positive impact on biomarkers? Is there a clinical response with such a short duration of treatment and likely sub-optimal dosing?

Prurisol
: The phase 2b trial is further exploring the dose/response relationship and is critical to knowing what we really have. The trial should be fully enrolled. We've discussed hoped for results at length in previous threads and results in the neighborhood of Otezla should give us a very lucrative deal.

Deals take time, negotiations are not publicized, and they don't usually occur in our imagined timeframes. One morning in the hopefully not too distant future we'll get some kind of deal. And then there will be another. And perhaps another.

I have full confidence in Leo and the IPIX team.

biodoc