It is stated right in the presentation yesterday. Give it a listen when you ahve a chance:
http://www.media-server.com/m/p/ad4gm88c
Here is a nice recap from another poster on IHUB:
So yes, Kevetrin has SHRUNK a tumor.
http://www.media-server.com/m/p/ad4gm88c
Here is a nice recap from another poster on IHUB:
These are my notes from the audio presentation with timestamps and added links for additional information--I hope it helps some other investors out there...
KEVETRIN
- CTIX is currently recruiting for cohort 7
- (4:30) Even though patients with stage 4 cancers are expected to be able to take only one cycle of trial drugs, nearly all the patients in the Kevetrin trial have been able to take multiple cycles.
- (6:10) [Info on how many cycles each patient completed]
- (6:25) There is evidence of tumor regression. [ This must have occurred at or below 75mg/m2 dosage because the results for cohort 6, which was set at 110mg/m2, have not come back yet. ]
- There are three planned follow-on trials for Kevetrin:
1. (6:40) Acute & Chronic Myeloid Leukemia (Phase 1B) given with Cytarabine [ http://www.rxlist.com/cytarabine-drug.htm] in a new formulation at University of Bologna, Italy
2. (7:00) Drug resistant renal cancer cell line 786 (Phase 2) given with Sunitinib [ http://www.rxlist.com/sutent-drug.htm] at BIDMC
3. (7:40) “Another” phase 2 trial being planned for solid tumors…[ I wonder what this one is about?! ]
BRILACIDIN
- (11:05) Brilacidin is an immunomodulatory antimicrobial [ http://medical-dictionary.thefreedictionary.c...modulatory]
- There is nothing else out there like it
- It is bactericidal, anti-inflammatory, and anti-biofilm
- It restores and maintains “healthy barriers” in the body, i.e. skin and mucus membranes
- (12:20) It has the opportunity to be useful for bacterial, fungal, parasitic, and viral applications
- (12:35) It has the opportunity to be useful against inflammatory conditions that disrupt the barriers. Uses may include, but not limited to, oral mucositis, Inflammatory Bowel Disease , proctitis, dermatitis, acne, burns or abrasions. This may also extend to conditions affecting the membrane of the lungs such as respiratory mucosa, cystic fibrosis, and asthma.
- (14:05) There is a very low chance of resistance because Brilacidin mimics our own immune system
- (14:40) Brilacidin could have sub-MIC activity, which no other antibiotic has. It kills rapidly, lowering the chances of mutations. It also disrupts biofilms [ http://en.wikipedia.org/wiki/Biofilm] .
- (16:40) Comparing Brilacidin to Daptomycin [ http://www.rxlist.com/cubicin-drug.htm] , [brand name Cubicin] had approximately 8% of market sales totaling around $700 million in 2011, and those sales have now jumped up to close to a $1 billion. Brilacidin is estimated to take about $100 million.
- (1825) Some other uses may include diabetic foot infection, infective endocarditis [ http://www.mayoclinic.org/diseases-conditions...n-20022403] , and prosthetic joint infections [ http://www.uptodate.com/contents/treatment-of...infections] .
- (22:25) The FDA is very supportive of the planned Phase 2B single-dose trial where groups will be administered .6mg/kg for 1-day, .8mg/kg for 1-day, and then groups of 3-day dosings.
BRILACIDIN-OM
- Brilacidin for OM will be mixed with saline and water.
- (24:05) Kepivance [ http://www.rxlist.com/kepivance-drug.htm] , which is currently the only approved agent for use against OM costs $10,000 per cycle, and there are around 450,000 patients treated for OM each year in the U.S. alone. [ That’s a potential $4,500,000,000 market ]
- (25:40) Their plan for NDA approval: Phase 2 will be a Proof of Concept trial, and include about 60-120 patients. Phase 3 will include approximately 240 patients.
- (27:30) Cellceutix received proposals bids for formulation work, and a manufacturer needs to be selected still [ probably the “billion-dollar companies” CTIX has been talking to ]
KEVETRIN
- CTIX is currently recruiting for cohort 7
- (4:30) Even though patients with stage 4 cancers are expected to be able to take only one cycle of trial drugs, nearly all the patients in the Kevetrin trial have been able to take multiple cycles.
- (6:10) [Info on how many cycles each patient completed]
- (6:25) There is evidence of tumor regression. [ This must have occurred at or below 75mg/m2 dosage because the results for cohort 6, which was set at 110mg/m2, have not come back yet. ]
- There are three planned follow-on trials for Kevetrin:
1. (6:40) Acute & Chronic Myeloid Leukemia (Phase 1B) given with Cytarabine [ http://www.rxlist.com/cytarabine-drug.htm] in a new formulation at University of Bologna, Italy
2. (7:00) Drug resistant renal cancer cell line 786 (Phase 2) given with Sunitinib [ http://www.rxlist.com/sutent-drug.htm] at BIDMC
3. (7:40) “Another” phase 2 trial being planned for solid tumors…[ I wonder what this one is about?! ]
BRILACIDIN
- (11:05) Brilacidin is an immunomodulatory antimicrobial [ http://medical-dictionary.thefreedictionary.c...modulatory]
- There is nothing else out there like it
- It is bactericidal, anti-inflammatory, and anti-biofilm
- It restores and maintains “healthy barriers” in the body, i.e. skin and mucus membranes
- (12:20) It has the opportunity to be useful for bacterial, fungal, parasitic, and viral applications
- (12:35) It has the opportunity to be useful against inflammatory conditions that disrupt the barriers. Uses may include, but not limited to, oral mucositis, Inflammatory Bowel Disease , proctitis, dermatitis, acne, burns or abrasions. This may also extend to conditions affecting the membrane of the lungs such as respiratory mucosa, cystic fibrosis, and asthma.
- (14:05) There is a very low chance of resistance because Brilacidin mimics our own immune system
- (14:40) Brilacidin could have sub-MIC activity, which no other antibiotic has. It kills rapidly, lowering the chances of mutations. It also disrupts biofilms [ http://en.wikipedia.org/wiki/Biofilm] .
- (16:40) Comparing Brilacidin to Daptomycin [ http://www.rxlist.com/cubicin-drug.htm] , [brand name Cubicin] had approximately 8% of market sales totaling around $700 million in 2011, and those sales have now jumped up to close to a $1 billion. Brilacidin is estimated to take about $100 million.
- (1825) Some other uses may include diabetic foot infection, infective endocarditis [ http://www.mayoclinic.org/diseases-conditions...n-20022403] , and prosthetic joint infections [ http://www.uptodate.com/contents/treatment-of...infections] .
- (22:25) The FDA is very supportive of the planned Phase 2B single-dose trial where groups will be administered .6mg/kg for 1-day, .8mg/kg for 1-day, and then groups of 3-day dosings.
BRILACIDIN-OM
- Brilacidin for OM will be mixed with saline and water.
- (24:05) Kepivance [ http://www.rxlist.com/kepivance-drug.htm] , which is currently the only approved agent for use against OM costs $10,000 per cycle, and there are around 450,000 patients treated for OM each year in the U.S. alone. [ That’s a potential $4,500,000,000 market ]
- (25:40) Their plan for NDA approval: Phase 2 will be a Proof of Concept trial, and include about 60-120 patients. Phase 3 will include approximately 240 patients.
- (27:30) Cellceutix received proposals bids for formulation work, and a manufacturer needs to be selected still [ probably the “billion-dollar companies” CTIX has been talking to ]
So yes, Kevetrin has SHRUNK a tumor.
