This subject of SGX942 completing their phase 2 fo
Post# of 72445
Posted On: 12/17/2015 12:05:50 AM
This subject of SGX942 completing their phase 2 for oral mucositis was broached on the other board. I thought it might be interesting to discuss it here. The implication (FUD imho) was made that the hamster pouch models used in testing oral mucositis may not be an accurate predictor of the results one could expect in the human trials. While of course if animal studies were always replicated in humans we wouldn't need to do the human trials at all but, here were the results in the Hamster Model of SGX942. The phase 2 matched the predictions almost perfectly.
Oral Mucositis Induced in Hamsters by Fractionated Radiation -GOLD STANDARD
•
On study days 0, 1, 2, 3, 6, 7, 8 and 9, male Syrian Golden Hamsters (N=12/group) were given acute radiation (7.5 Gy) to their left buccalcheek pouch
Hamster
"GOLD STANDARD Animal Model of Mucositis related to H&N Cancer
• Decreased duration of mucositis by ~50%;
• Decreased peak severity from 3.4 to 3.0."
Human
"In the 1.5 mg/kg treatment group, the median duration of severe oral mucositis was decreased by 50% , from 18 days to 9 days (p=0.099), meeting the prospectively defined statistical threshold of p<0.1 in the study protocol."
Coincidentally the Brilacidin OM trials were even conducted by the same individual who conducted the SGX942 OM trials.
"One of the leading investigators in oral mucositis, Stephen T. Sonis, DMD, DMSc, Professor of Oral Medicine at Harvard School of Dental Medicine and Member of the Soligenix Oral Mucositis Medical Advisory Board noted , "Oral mucositis is a devastating side effect of CRT used for the treatment of head and neck cancers, which compromises patients' tolerability of therapy and quality of life, and adds to health and economic burdens associated with care"
"The results from both models showed that brilacidin when administered as an oral rinse significantly reduced the severity and duration of ulcerative mucositis. These studies were conducted at Biomodels by Stephen T. Sonis, DMD, DMSc, Chief Medical Officer at Biomodels, Professor of Oral Medicine at Harvard’s School of Dental Medicine. - See more at: http://cellceutix.com/brilacidin-om/#sthash.U9GWZrXG.dpuf
This seems to bode very well for Brilacidin in my opinion. A reduction to 3.3% seems a heck of alot better than a reduction to 50%.
" Brilacidin significantly reduced the daily mucositis scores prior to peak mucositis and throughout the remaining course of treatment (p<0.001), and reduced the number of animal days with ulcerations from 55% in vehicle treated hamsters to 3.3% (P<0.001), a reduction of approximately 94% . - See more at: http://cellceutix.com/brilacidin-om/#sthash.U9GWZrXG.dpuf
All that being said I have a question hopefully someone here can answer.
"This exploratory study achieved all objectives, including identifying a best dose of 1.5 mg/kg . The study enrolled 111 patients across three SGX942 dose groups (i.e. , 1.5, 3.0, and 6.0 mg/kg ) and a placebo group and evaluated patients undergoing CRT for head and neck cancer. In the 1.5 mg/kg treatment group, the median duration of severe oral mucositis was decreased by 50%, from 18 days to 9 days (p=0.099),
So why would they chose the lowest dose and not bother to even mention the results from the higher doses. While I realize that the goal is to use the lowest effective dose that works, it seems to imply that a higher dose did not produce better results. Does that seem strange?
http://www.wboy.com/story/30763663/soligenix-...d-and-neck
https://www.google.com/url?q=http://www.proac...0gNgQ0ClOQ
Oral Mucositis Induced in Hamsters by Fractionated Radiation -GOLD STANDARD
•
On study days 0, 1, 2, 3, 6, 7, 8 and 9, male Syrian Golden Hamsters (N=12/group) were given acute radiation (7.5 Gy) to their left buccalcheek pouch
Hamster
"GOLD STANDARD Animal Model of Mucositis related to H&N Cancer
• Decreased duration of mucositis by ~50%;
• Decreased peak severity from 3.4 to 3.0."
Human
"In the 1.5 mg/kg treatment group, the median duration of severe oral mucositis was decreased by 50% , from 18 days to 9 days (p=0.099), meeting the prospectively defined statistical threshold of p<0.1 in the study protocol."
Coincidentally the Brilacidin OM trials were even conducted by the same individual who conducted the SGX942 OM trials.
"One of the leading investigators in oral mucositis, Stephen T. Sonis, DMD, DMSc, Professor of Oral Medicine at Harvard School of Dental Medicine and Member of the Soligenix Oral Mucositis Medical Advisory Board noted , "Oral mucositis is a devastating side effect of CRT used for the treatment of head and neck cancers, which compromises patients' tolerability of therapy and quality of life, and adds to health and economic burdens associated with care"
"The results from both models showed that brilacidin when administered as an oral rinse significantly reduced the severity and duration of ulcerative mucositis. These studies were conducted at Biomodels by Stephen T. Sonis, DMD, DMSc, Chief Medical Officer at Biomodels, Professor of Oral Medicine at Harvard’s School of Dental Medicine. - See more at: http://cellceutix.com/brilacidin-om/#sthash.U9GWZrXG.dpuf
This seems to bode very well for Brilacidin in my opinion. A reduction to 3.3% seems a heck of alot better than a reduction to 50%.
" Brilacidin significantly reduced the daily mucositis scores prior to peak mucositis and throughout the remaining course of treatment (p<0.001), and reduced the number of animal days with ulcerations from 55% in vehicle treated hamsters to 3.3% (P<0.001), a reduction of approximately 94% . - See more at: http://cellceutix.com/brilacidin-om/#sthash.U9GWZrXG.dpuf
All that being said I have a question hopefully someone here can answer.
"This exploratory study achieved all objectives, including identifying a best dose of 1.5 mg/kg . The study enrolled 111 patients across three SGX942 dose groups (i.e. , 1.5, 3.0, and 6.0 mg/kg ) and a placebo group and evaluated patients undergoing CRT for head and neck cancer. In the 1.5 mg/kg treatment group, the median duration of severe oral mucositis was decreased by 50%, from 18 days to 9 days (p=0.099),
So why would they chose the lowest dose and not bother to even mention the results from the higher doses. While I realize that the goal is to use the lowest effective dose that works, it seems to imply that a higher dose did not produce better results. Does that seem strange?
http://www.wboy.com/story/30763663/soligenix-...d-and-neck
https://www.google.com/url?q=http://www.proac...0gNgQ0ClOQ
(0)
(0)