CTIX Opinions 08/20/2014 05:29:36 $CTIX
Screw you with your "good luck and God Bless" go CTIX
Yes, but the Aug 7 PR said "Cellceutix is developing Prurisol™ under guidance from the U.S. Food and Drug Administration that a 505(b)(2) designation is an acceptable pathway to expedite development of the compound for treating psoriasis. Upon receipt of the final report Cellceutix will schedule a meeting with the FDA to advance Prurisol into a Phase 2/3 clinical trial as quickly as possible."
- See more at: http://cellceutix.com/cellceutix-anti-psorias...ejuzQ.dpuf
CTIX Stock Message Board http://investorshangout.com/Cellceutix-Corpor...TIX-87375/
Regarding Prurisol and the next larger Phase II trial
The following is an excerpt from the latest 10Q
"...The trial, activated in April of 2014, is expected to complete dosing in June 2014. Additional time will be necessary for laboratory analysis. Only upon a successful study completion, the Company will move forward with the initiation of a larger Phase 2 trial under the guidance from the FDA that a 505(b)(2) designation is an appropriate developmental pathway for Prurisol.
Prurisol was manufactured and formulated for Cellceutix by Dr. Reddy's Laboratories and was completed in August 2013...."
http://www.sec.gov/Archives/edgar/data/135525...ix_10q.htm
Good luck and GOD bless,
George
B-OM is all but a slam dunk for a Phase 2/3 start before Christmas. So, that's one. For Prurisol, there is some confusion about whether the next trial will be Phase 2 or 2/3. The most recent PR said Phase 2 start in 3 to 4 months. I'm hoping it was a typo, like some other posters who caught it before I noticed the change.
For those of you who expect no tumor reduction from the Phase 1 trial, now that K is on the cusp of even higher dosing, look at these 3 charts for K against xenografts of 2 types of lung tumors. Note the blue lines in A and C and the red line in B. Not just tumor delay or arrest, but significant reduction. K showed similar efficacy against pancreatic cancer, a cancer for which there is currently no effective treatment. As I keep saying, multiple cycles has cumulative efficacy. If 215 mg/m2 is deemed safe, some will have 2 or more cycles at 165 with an upcoming cycle at 215. D is K alone against a type of Leukemia.
A possible win win win situation for Kevetrin
Curr Drug Targets. 2014 Jan;15(1):114-23.
MDM2-p53 interaction in paediatric solid tumours: preclinical rationale, biomarkers and resistance.
Barone G, Tweddle DA, Shohet JM, Chesler L, Moreno L, Pearson AD, Van Maerken T1.
Author information
Abstract
p53 is one of the main regulators of apoptosis, senescence, cell cycle arrest and DNA repair. The expression, function and stabilization of p53 are governed by a complex network of regulators including p14(ARF) and MDM2. MDM2 is the main negative regulator of p53 activity and stability. Unlike tumours in adults, which tend to overcome p53 regulation by p53 mutations, the paediatric tumours neuroblastoma and sarcoma frequently retain wild type p53. Nevertheless, in childhood cancer the p53 pathway is commonly impaired due to upstream MDM2-p14(ARF)-p53 network aberrations. In contrast, aberrations of the p53 downstream pathway are very rare. In cancer cells with intact p53 downstream function MDM2 inhibition, and subsequent rapid increases in nuclear p53 levels, potently "re-activate" dormant apoptotic pathways and rapidly induce apoptotic cell death. As a result MDM2-p53 interaction inhibitors, including cis-imidazolines analogs (Nutlins), are potentially very effective agents in neuroblastoma and sarcomas. Predictive biomarkers are important as a lack of p53 mutations appears to reliably predict response to these inhibitors. Tumours should be screened for p53 mutations in children considered for MDM2-p53 interaction inhibitors. In addition, it is essential that other predictive biomarkers are investigated. The serum concentration of macrophage inhibitory cytokine- 1 (MIC-1) may be a good pharmacodynamic biomarker based on recent findings. In conclusion, targeting the interaction between p53 and its main negative regulator MDM2 represents a major new therapeutic approach in poor prognosis paediatric malignancies without p53 mutations.
http://www.ncbi.nlm.nih.gov/pubmed/?term=MDM2...Resistance
Supporting reasoning
http://cellceutix.com/wp-content/uploads/pdfs...0FINAL.pdf
Good luck and GOD bless,
George
How many Phase III trials will Cellceutix have during 2015???
I believe that we could hear about the start of a Phase III trial using Prurisol as a treatment for psoriasis before CHRISTmas 2014!!!
I believe that we could hear about at least one and maybe more Phase III trials using B to treat a variety of infections.
These may be fairly short trials lasting a year or less before FDA approval.
JMHO
Good luck and GOD bless,
George
Sox040713
I mean either.
I don't believe that Kevetrin will be used as a stand alone treatment except for possibly a few cancers. However, I believe that it will be a very good combination with chemotherapy and/or radiation therapy.
I don't believe that Kevetrin will be a stand alone cure for cancer except possibly for some types of cancer at very early stages.
I hope that I am wrong about this and that Kevetrin is proven to be a cure for cancer.
Good luck and GOD bless,
George
George, by miracles do you mean a cure or a stand-alone drug against solid tumors?
Today this was the fourth-most read board on all of iHub. I think that is a testament to the quality of posters on this board.
I also noticed that this board's followers is at an all-time high!
I am really excited to see what R&R has in store for us--I think it is going to light this board up!
Bologna is waiting on the MTD from Kevetrin P1
@BK - You are more familiar with biotech deals. Given the huge potential for the B platform but also the fact that there are still a lot of unknowns; is there precedent for a deal with lower upfront money and higher downstream royalties?
For instance, (for the entire B platform) maybe a couple of hundred million dollars upfront and 40% royalties with a $100 million minimum guaranteed annually. Have you seen any similar deals?
BK said...
Quote:
Considering market, B-ABSSSI license alone is worth $350 million to $500 million ($700 million is within range but a little on the high side IMO), including $35 million to $100 million upfront.
We now have 6 other 1/2 billion to billion dollar indications/formulations for B:
Brilacidin-OM
Brilacidin-Ocular
Brilacidin-Otic
Gram Negative Bacteria
Candidiasis
Diabetic Foot Infections/Ulcers
That's a lot of Phase 2/3 trials to move, so it would be very nice to license ABSSSI and pay for everything else, including K and P.
LOL, and I reserve the right to consult my financial advisor Dr Rally on these matters.....................
Good luck and GOD bless,
Go CTIX!
I agree with George, Kevetrin will be a game changer but it is several years out.
many combo trials await and lets not forget Bologna
Oh, by the way, why hasn't that trial started yet ?
Maybe Leo will update us at R and R in NYC
20 days left till conference updates
Yawwwn. Not again. This horse is dead. George did you miss a chance to average down. Come on let's move along. It's been a good day for Pete's sake. Can we give it a days rest
As I have said before do not expect miracles for Kevetrin.
I do however that Kevetrin will be a blockbuster drug as an diction to standard chemotherapy and/or radiation therapy.
I hope that EllaRuth is right, but I doubt it.
Good luck and GOD bless,
George
Miles, hang in there. Charts nor anyone can tell you when a stock will be quadruple swing term then more. Sound familiar? Long over 100k on that one and done for the year? Not by a long shot. In fact, long again in that one and you know the share count. The secret is the best stock now hopefully at the right time. And if the timing is off, you're best stock now will still save in the end. Don't allow the short term TA mumbo jumbo to distort. Use the reading I did to temp sell like on our other one, it's the best there is and I posted it real time. No worries my friend and Shalom......................
Patience.......the art of concealing ones impatience. Our patience will be rewarded in time. We have breathed this $2 air before, but it smells sweeter this time, knowing good news on all fronts and trial escalation is eminent. SP dilution by Aspire selling is disconcerting, yes....but is still necessary. Three solid days consecutively. Yeah baby, I'll take that. Go CTIX and Go Gamecocks!!!! Kickoff is only 8 days away.
Screw you with your "good luck and God Bless" go CTIX
Yes, but the Aug 7 PR said "Cellceutix is developing Prurisol™ under guidance from the U.S. Food and Drug Administration that a 505(b)(2) designation is an acceptable pathway to expedite development of the compound for treating psoriasis. Upon receipt of the final report Cellceutix will schedule a meeting with the FDA to advance Prurisol into a Phase 2/3 clinical trial as quickly as possible."
- See more at: http://cellceutix.com/cellceutix-anti-psorias...ejuzQ.dpuf
CTIX Stock Message Board http://investorshangout.com/Cellceutix-Corpor...TIX-87375/
Regarding Prurisol and the next larger Phase II trial
The following is an excerpt from the latest 10Q
"...The trial, activated in April of 2014, is expected to complete dosing in June 2014. Additional time will be necessary for laboratory analysis. Only upon a successful study completion, the Company will move forward with the initiation of a larger Phase 2 trial under the guidance from the FDA that a 505(b)(2) designation is an appropriate developmental pathway for Prurisol.
Prurisol was manufactured and formulated for Cellceutix by Dr. Reddy's Laboratories and was completed in August 2013...."
http://www.sec.gov/Archives/edgar/data/135525...ix_10q.htm
Good luck and GOD bless,
George
B-OM is all but a slam dunk for a Phase 2/3 start before Christmas. So, that's one. For Prurisol, there is some confusion about whether the next trial will be Phase 2 or 2/3. The most recent PR said Phase 2 start in 3 to 4 months. I'm hoping it was a typo, like some other posters who caught it before I noticed the change.
For those of you who expect no tumor reduction from the Phase 1 trial, now that K is on the cusp of even higher dosing, look at these 3 charts for K against xenografts of 2 types of lung tumors. Note the blue lines in A and C and the red line in B. Not just tumor delay or arrest, but significant reduction. K showed similar efficacy against pancreatic cancer, a cancer for which there is currently no effective treatment. As I keep saying, multiple cycles has cumulative efficacy. If 215 mg/m2 is deemed safe, some will have 2 or more cycles at 165 with an upcoming cycle at 215. D is K alone against a type of Leukemia.
A possible win win win situation for Kevetrin
Curr Drug Targets. 2014 Jan;15(1):114-23.
MDM2-p53 interaction in paediatric solid tumours: preclinical rationale, biomarkers and resistance.
Barone G, Tweddle DA, Shohet JM, Chesler L, Moreno L, Pearson AD, Van Maerken T1.
Author information
Abstract
p53 is one of the main regulators of apoptosis, senescence, cell cycle arrest and DNA repair. The expression, function and stabilization of p53 are governed by a complex network of regulators including p14(ARF) and MDM2. MDM2 is the main negative regulator of p53 activity and stability. Unlike tumours in adults, which tend to overcome p53 regulation by p53 mutations, the paediatric tumours neuroblastoma and sarcoma frequently retain wild type p53. Nevertheless, in childhood cancer the p53 pathway is commonly impaired due to upstream MDM2-p14(ARF)-p53 network aberrations. In contrast, aberrations of the p53 downstream pathway are very rare. In cancer cells with intact p53 downstream function MDM2 inhibition, and subsequent rapid increases in nuclear p53 levels, potently "re-activate" dormant apoptotic pathways and rapidly induce apoptotic cell death. As a result MDM2-p53 interaction inhibitors, including cis-imidazolines analogs (Nutlins), are potentially very effective agents in neuroblastoma and sarcomas. Predictive biomarkers are important as a lack of p53 mutations appears to reliably predict response to these inhibitors. Tumours should be screened for p53 mutations in children considered for MDM2-p53 interaction inhibitors. In addition, it is essential that other predictive biomarkers are investigated. The serum concentration of macrophage inhibitory cytokine- 1 (MIC-1) may be a good pharmacodynamic biomarker based on recent findings. In conclusion, targeting the interaction between p53 and its main negative regulator MDM2 represents a major new therapeutic approach in poor prognosis paediatric malignancies without p53 mutations.
http://www.ncbi.nlm.nih.gov/pubmed/?term=MDM2...Resistance
Supporting reasoning
http://cellceutix.com/wp-content/uploads/pdfs...0FINAL.pdf
Good luck and GOD bless,
George
How many Phase III trials will Cellceutix have during 2015???
I believe that we could hear about the start of a Phase III trial using Prurisol as a treatment for psoriasis before CHRISTmas 2014!!!
I believe that we could hear about at least one and maybe more Phase III trials using B to treat a variety of infections.
These may be fairly short trials lasting a year or less before FDA approval.
JMHO
Good luck and GOD bless,
George
Sox040713
I mean either.
I don't believe that Kevetrin will be used as a stand alone treatment except for possibly a few cancers. However, I believe that it will be a very good combination with chemotherapy and/or radiation therapy.
I don't believe that Kevetrin will be a stand alone cure for cancer except possibly for some types of cancer at very early stages.
I hope that I am wrong about this and that Kevetrin is proven to be a cure for cancer.
Good luck and GOD bless,
George
George, by miracles do you mean a cure or a stand-alone drug against solid tumors?
Today this was the fourth-most read board on all of iHub. I think that is a testament to the quality of posters on this board.
I also noticed that this board's followers is at an all-time high!
I am really excited to see what R&R has in store for us--I think it is going to light this board up!
Bologna is waiting on the MTD from Kevetrin P1
@BK - You are more familiar with biotech deals. Given the huge potential for the B platform but also the fact that there are still a lot of unknowns; is there precedent for a deal with lower upfront money and higher downstream royalties?
For instance, (for the entire B platform) maybe a couple of hundred million dollars upfront and 40% royalties with a $100 million minimum guaranteed annually. Have you seen any similar deals?
BK said...
Quote:
Considering market, B-ABSSSI license alone is worth $350 million to $500 million ($700 million is within range but a little on the high side IMO), including $35 million to $100 million upfront.
We now have 6 other 1/2 billion to billion dollar indications/formulations for B:
Brilacidin-OM
Brilacidin-Ocular
Brilacidin-Otic
Gram Negative Bacteria
Candidiasis
Diabetic Foot Infections/Ulcers
That's a lot of Phase 2/3 trials to move, so it would be very nice to license ABSSSI and pay for everything else, including K and P.
LOL, and I reserve the right to consult my financial advisor Dr Rally on these matters.....................
Good luck and GOD bless,
Go CTIX!
I agree with George, Kevetrin will be a game changer but it is several years out.
many combo trials await and lets not forget Bologna
Oh, by the way, why hasn't that trial started yet ?
Maybe Leo will update us at R and R in NYC
20 days left till conference updates
Yawwwn. Not again. This horse is dead. George did you miss a chance to average down. Come on let's move along. It's been a good day for Pete's sake. Can we give it a days rest
As I have said before do not expect miracles for Kevetrin.
I do however that Kevetrin will be a blockbuster drug as an diction to standard chemotherapy and/or radiation therapy.
I hope that EllaRuth is right, but I doubt it.
Good luck and GOD bless,
George
Miles, hang in there. Charts nor anyone can tell you when a stock will be quadruple swing term then more. Sound familiar? Long over 100k on that one and done for the year? Not by a long shot. In fact, long again in that one and you know the share count. The secret is the best stock now hopefully at the right time. And if the timing is off, you're best stock now will still save in the end. Don't allow the short term TA mumbo jumbo to distort. Use the reading I did to temp sell like on our other one, it's the best there is and I posted it real time. No worries my friend and Shalom......................
Patience.......the art of concealing ones impatience. Our patience will be rewarded in time. We have breathed this $2 air before, but it smells sweeter this time, knowing good news on all fronts and trial escalation is eminent. SP dilution by Aspire selling is disconcerting, yes....but is still necessary. Three solid days consecutively. Yeah baby, I'll take that. Go CTIX and Go Gamecocks!!!! Kickoff is only 8 days away.
