More on B-OM vs. potential competitors (credit to slcimmuno).
INNOVATION (Brilacidin / PMX-30063)
>Phase 2 (n=61)
>Oral Rinse (Swish and Spit x3 per day for 7 weeks)
>Primary Endpoint: Incidence of SOM; TEAEs
>May 2015-Dec 2017
https://clinicaltrials.gov/ct2/show/record/NCT02324335
Study showed a markedly reduced rate of Severe OM (WHO Grade ≥ 3): Active Arm (Brilacidin): 2 of 9 patients (22.2 percent); Control Arm (Placebo): 7 of 10 patients (70 percent)
http://www.ipharminc.com/press-release/2017/3...-treatment
SOLIGENIX (SGX492) (Dusquetide)
>Phase 3 (pivotal) (n=190)
>IV (4 min) x2 per week
>Primary Endpoint: Reduction in SOM
>July 2017-March 2019
https://clinicaltrials.gov/ct2/show/record/NCT03237325
Consistent with preclinical findings, SGX942 at a dose of 1.5 mg/kg demonstrated positive improvements in decreasing the duration of severe oral mucositis by 50% overall compared to the placebo group, from 18 days to 9 days (p=0.099). In patients at the highest risk of developing severe oral mucositis (i.e., those receiving concomitant cisplatin chemotherapy of 80-100 mg/m2 every third week), the reduction in the duration of severe oral mucositis was even more significant at 67% when treated with SGX942 1.5 mg/kg, from 30 days to 10 days (p=0.04).
http://www.soligenix.com/news/soligenix-initi...-patients/
ORAGENICS (AG013)
>Oral x3 per day
>Phase 2 (n=200)
>July 2017-May 2020
>Primary Endpoint:
? Reduction in Duration and Time to Develop of OM
? Reduction in Incidence of OM
https://clinicaltrials.gov/ct2/show/record/NCT03234465
“The initiation of the trial represents a significant milestone for Oragenics. We expect to report preliminary data on the initial 20 enrolled patients by the end of 2017 with completion and full results of the trial expected by the end of 2018.”
https://www.oragenics.com/news-media/press-re...l-trial-of
Data from the Phase 1B trial published in the journal Cancer showed AG013 was safe, well tolerated, and demonstrated preliminary efficacy with a 35% reduction in the duration of ulcerative OM compared to placebo.
https://www.oragenics.com/news-media/press-re...nfirmatory
https://d1io3yog0oux5.cloudfront.net/_9ec5ef9...l_2017.pdf
ONXEO/MONOPAR (Validive)
>Tablet
>Phase 3 (details tbd)
>Efficacy
http://monopartherapeutics.com/phase_II
The incidence of SOM (primary endpoint) was reduced by 26.3% (40% relative to placebo) in OPC patients treated with Validive (100 µg) (p=0.09)
https://www.onxeo.com/onxeo-grants-exclusive-...rapeutics/
http://monopartherapeutics.com/validive
ENZYCHEM (EC-18)
>Oral x2 daily
>Phase 2 (stage 1, safety cohort, n=24; stage 2, efficacy, n=60)
>Jan 2018-June 2019
>Primary Endpoint: Reduction in Incidence of SOM
https://clinicaltrials.gov/ct2/show/record/NCT03200340
https://www.prnewswire.com/news-releases/enzy...98625.html
http://m.pulsenews.co.kr/view.php?sc=30800018...;no=659060
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2698195/
KEPIVANCE / PALIFERMIN
> Approval (low efficacy bar):
-- 2004, only OM Drug on Mkt... based primarily on results in 212 patients
-- In the primary efficacy study, the median duration of WHO grade 3 and 4 mucositis was significantly shorter (three days vs. nine days) in patients receiving palifermin. The reduction in median duration of severe mucositis reflects both a reduction in the incidence of severe mucositis (67 percent vs. 98 percent) and a shorter median duration in those who experienced severe mucositis (six days vs. nine days)
> Admin (suboptimal): IV ... 3 days before chemo and 3 days after
> Revenue: Kepivance took in close to ~$100m year 2009-2011...
• 2009: $109.9 million
• 2010: $94.8 million
• 2011: $77.9 million
> Pulled from Europe; SOBI no longer marketing it - had earlier in 2013 sought to look at its potential in HNC, not just HST (limited label)... no longer listed as source of Rev in SOBI filings
http://www.ema.europa.eu/docs/en_GB/document_...204617.pdf
https://globenewswire.com/news-release/2013/0...Amgen.html
http://www.kepivance.com
https://www.cancer.gov/about-cancer/treatment...palifermin
https://www.accessdata.fda.gov/drugsatfda_doc...e_medr.PDF (see pages 16-21)
https://en.m.wikipedia.org/wiki/Palifermin
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4117550/
INNOVATION (Brilacidin / PMX-30063)
>Phase 2 (n=61)
>Oral Rinse (Swish and Spit x3 per day for 7 weeks)
>Primary Endpoint: Incidence of SOM; TEAEs
>May 2015-Dec 2017
https://clinicaltrials.gov/ct2/show/record/NCT02324335
Study showed a markedly reduced rate of Severe OM (WHO Grade ≥ 3): Active Arm (Brilacidin): 2 of 9 patients (22.2 percent); Control Arm (Placebo): 7 of 10 patients (70 percent)
http://www.ipharminc.com/press-release/2017/3...-treatment
SOLIGENIX (SGX492) (Dusquetide)
>Phase 3 (pivotal) (n=190)
>IV (4 min) x2 per week
>Primary Endpoint: Reduction in SOM
>July 2017-March 2019
https://clinicaltrials.gov/ct2/show/record/NCT03237325
Consistent with preclinical findings, SGX942 at a dose of 1.5 mg/kg demonstrated positive improvements in decreasing the duration of severe oral mucositis by 50% overall compared to the placebo group, from 18 days to 9 days (p=0.099). In patients at the highest risk of developing severe oral mucositis (i.e., those receiving concomitant cisplatin chemotherapy of 80-100 mg/m2 every third week), the reduction in the duration of severe oral mucositis was even more significant at 67% when treated with SGX942 1.5 mg/kg, from 30 days to 10 days (p=0.04).
http://www.soligenix.com/news/soligenix-initi...-patients/
ORAGENICS (AG013)
>Oral x3 per day
>Phase 2 (n=200)
>July 2017-May 2020
>Primary Endpoint:
? Reduction in Duration and Time to Develop of OM
? Reduction in Incidence of OM
https://clinicaltrials.gov/ct2/show/record/NCT03234465
“The initiation of the trial represents a significant milestone for Oragenics. We expect to report preliminary data on the initial 20 enrolled patients by the end of 2017 with completion and full results of the trial expected by the end of 2018.”
https://www.oragenics.com/news-media/press-re...l-trial-of
Data from the Phase 1B trial published in the journal Cancer showed AG013 was safe, well tolerated, and demonstrated preliminary efficacy with a 35% reduction in the duration of ulcerative OM compared to placebo.
https://www.oragenics.com/news-media/press-re...nfirmatory
https://d1io3yog0oux5.cloudfront.net/_9ec5ef9...l_2017.pdf
ONXEO/MONOPAR (Validive)
>Tablet
>Phase 3 (details tbd)
>Efficacy
http://monopartherapeutics.com/phase_II
The incidence of SOM (primary endpoint) was reduced by 26.3% (40% relative to placebo) in OPC patients treated with Validive (100 µg) (p=0.09)
https://www.onxeo.com/onxeo-grants-exclusive-...rapeutics/
http://monopartherapeutics.com/validive
ENZYCHEM (EC-18)
>Oral x2 daily
>Phase 2 (stage 1, safety cohort, n=24; stage 2, efficacy, n=60)
>Jan 2018-June 2019
>Primary Endpoint: Reduction in Incidence of SOM
https://clinicaltrials.gov/ct2/show/record/NCT03200340
https://www.prnewswire.com/news-releases/enzy...98625.html
http://m.pulsenews.co.kr/view.php?sc=30800018...;no=659060
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2698195/
KEPIVANCE / PALIFERMIN
> Approval (low efficacy bar):
-- 2004, only OM Drug on Mkt... based primarily on results in 212 patients
-- In the primary efficacy study, the median duration of WHO grade 3 and 4 mucositis was significantly shorter (three days vs. nine days) in patients receiving palifermin. The reduction in median duration of severe mucositis reflects both a reduction in the incidence of severe mucositis (67 percent vs. 98 percent) and a shorter median duration in those who experienced severe mucositis (six days vs. nine days)
> Admin (suboptimal): IV ... 3 days before chemo and 3 days after
> Revenue: Kepivance took in close to ~$100m year 2009-2011...
• 2009: $109.9 million
• 2010: $94.8 million
• 2011: $77.9 million
> Pulled from Europe; SOBI no longer marketing it - had earlier in 2013 sought to look at its potential in HNC, not just HST (limited label)... no longer listed as source of Rev in SOBI filings
http://www.ema.europa.eu/docs/en_GB/document_...204617.pdf
https://globenewswire.com/news-release/2013/0...Amgen.html
http://www.kepivance.com
https://www.cancer.gov/about-cancer/treatment...palifermin
https://www.accessdata.fda.gov/drugsatfda_doc...e_medr.PDF (see pages 16-21)
https://en.m.wikipedia.org/wiki/Palifermin
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4117550/
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