Posted On: 11/15/2016 11:02:40 AM
Post# of 72447
Now answering question from shareholders:
Which is getting most attention from potential partners, what's the time line?
It depends on developments. ALL 3 HAVE APPEAL FOR PARTNERSHIPS. Prurisol results have increased interest. UP and OM trials getting noticed.
K will be after we have data from 2A study to establish mechanism of action, and oral dosing.
Can't discuss timelines. Will do what potential partner wants in direction of trials.
WHY START WITH OM and UP for Bril?
Because of significant need with no treatments. First explore UP. If continues to be successful, potential for expanding for other inflammatory bowel diseases, AND DERMATOLOGICAL USES. (again, we knew this, but stressing it like this is interesting.)
Asks for comment on 4 patients from UP:
Read the press release for more complete data. Optimistic that we'll see more pronounced effects at higher doses
Why has it taken so long to advance Kevetrin? Anything to make it faster?
Some clinical trials take longer, and out of hands of sponsor company (Take that, Dana-Farber).
Trial was successful and laid groundwork for mid-stage trials.Will be exponentially faster. Change of protocol 3x/day for 3 weeks. Expect SIGNIFICANT progress in 1H 2017.
If oral formulation isn't ready for trial, will they use it in future trials?
Currently, intravenous. Working to shift to oral dose later in 2017, need toxicology studies.
Grant application for Kevetrin at Mayo?
Missed the cut-off based on score. Challenge was the multi-dosing needed. Oral dosing would be the best solution.
What next for Prurisol?
Meet with FDA for end of Phase 2, to start Phase 3. Will see if they will include a partner "if favorable."
Which is getting most attention from potential partners, what's the time line?
It depends on developments. ALL 3 HAVE APPEAL FOR PARTNERSHIPS. Prurisol results have increased interest. UP and OM trials getting noticed.
K will be after we have data from 2A study to establish mechanism of action, and oral dosing.
Can't discuss timelines. Will do what potential partner wants in direction of trials.
WHY START WITH OM and UP for Bril?
Because of significant need with no treatments. First explore UP. If continues to be successful, potential for expanding for other inflammatory bowel diseases, AND DERMATOLOGICAL USES. (again, we knew this, but stressing it like this is interesting.)
Asks for comment on 4 patients from UP:
Read the press release for more complete data. Optimistic that we'll see more pronounced effects at higher doses
Why has it taken so long to advance Kevetrin? Anything to make it faster?
Some clinical trials take longer, and out of hands of sponsor company (Take that, Dana-Farber).
Trial was successful and laid groundwork for mid-stage trials.Will be exponentially faster. Change of protocol 3x/day for 3 weeks. Expect SIGNIFICANT progress in 1H 2017.
If oral formulation isn't ready for trial, will they use it in future trials?
Currently, intravenous. Working to shift to oral dose later in 2017, need toxicology studies.
Grant application for Kevetrin at Mayo?
Missed the cut-off based on score. Challenge was the multi-dosing needed. Oral dosing would be the best solution.
What next for Prurisol?
Meet with FDA for end of Phase 2, to start Phase 3. Will see if they will include a partner "if favorable."
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