Hi Pete!
This answers your question re Kevetrin manufacture: http://cellceutix.com/cellceutix-back-in-the-...ncer-drug/
re your question to me - the answer has 2 parts. 1st - the evidence based part has to say that we only know that the drug at least met delineated protocol standards of toxicity thus allowing anticipated dose increase and cohort continuation. It is criteria specific to the company's previously submitted phI trial protocol(not hospital policy as is being falsely perpetrated elsewhere). That leaves us with very little information except known minimal or tolerable toxicity - anything from there is pure speculation.
Re speculation: I really, really have a good feeling that this drug will be found to have positive effect in this initial trial at doses quite tolerable to humans. I think they may end up with a wide treatment dosage range - allowing for wide treatment range. This is absolutely pure speculation. There is no information to support this view yet. The only concrete info for humans we have is cohort continuation indicating low or tolerable toxicity. No other data exists.
We will get word of deaths in cohorts after trial close. The trial will be written up for publication and phII/III application and investors will be able to see how this phI went. We'll know sooner if trial has to have early shutdown because death events are related to the drug. That outcome I just don't anticipate. None of us do, obviously, or else we wouldn't be here. None of this info is kept from ctix. (I did think they would be sharing more specifics as the trial matured - but they are treating it as though it is a later phase trial and keeping quiet.)They are given updates regularly. This will not be the case in more advanced trials.
Here is DF's guidance for IND protocol drafting - notice they include publication plan in the template they offer. (and for anyone who is interested - DF has a Clinical Investigator's Toolkit which can be found here: http://www.dfhcc.harvard.edu/clinical-researc...-toolkit/) (and Gov - if you copy and repost this link, which you are welcome to do, please don't tell everyone you spent hours looking for it, ok?)
Instructions and Guidance:
- Insert the study protocol(s) at this point.
- Phase 1 studies should provide an outline of the investigation including a statement of the objectives and purpose of the investigation, an estimate of subjects to be studied, a description of safety exclusions, a description of dosing plan (duration, dose, method used to determine dose), measures to ensure and evaluate subject safety (e.g., performance of blood chemistries, and toxicity-based stopping or dose adjustment rules).
- Phase 2 and 3 protocols should include alternative plans to address anticipated deviations (i.e. early crossover of non-responders to alternative therapy).
- Do not include the DF/HCC Institutional Data and Safety Monitoring Plan (DF/HCC DSMP) in this section. A full version of the DF/HCC DSMP will appear in section 9 of this IND application.
- Suggested content of the protocol as described by DF/HCC format is listed below.
- Remember to delete all instructions and guidance from the submitted application.
INDEX
SCHEMA
1.0 Objectives
2.0 Background
3.0 Participant Selection
4.0 Registration Procedures
5.0 Treatment Plan
6.0 Expected Toxicities and Dosing Delay/Dose Modifications
7.0 Drug Formulation and Administration
8.0 Correlative Studies
9.0 Study Calendar
10.0 Measurement of Effect
11.0 Adverse Event Reporting Requirements
12.0 Data and Safety Monitoring
13.0 Regulatory Consideration
14.0 Statistical Consideration
15.0 Publication Plan
16.0 References
17.0 Appendices
