Tiziana Life Sciences PLC   | AIM:TILS


KEY POINTS


Our research programme is expected to include:

  1. Ongoing pre-clinical animal studies, scheduled for completion in 2015, which are expected to determine if this leads to a significant improvement in survival when the agent is targeted to animal models with existing advanced metastatic disease.

  2. Lead generation, assay development and compound testing in 2014

  3. Identification of a clinical candidate, end 2015

  4. NDA preparation and submission, end of 2016

 

R&D Pipeline

We have identified a lead candidate (JS6) which inhibits Bcl-3 at nanomolar concentrations in in vitro assays with no overt toxicity measured up to millimolar concentrations. Our initial research is aimed at discovering further inhibitors (“BCL3i”) molecules with improved profiles. Ongoing pre-clinical studies, to be completed in 2015, will determine if this leads to a significant improvement in survival when the agent is targeted to animal models with either newly initiated or existing advanced metastatic disease.

OUR RESEARCH PROGRAMME



bcl-3 Lead generation, assay development and compound testing


  1. A combination of the production of new molecules and the testing of these molecules will result in milestone payments being payable to Cardiff University as more leads are generated and tested.

  2. Compounds tested in in vitro assays looking for at least equivalent bioactivity to the current lead (JS6)

  3. -P50 binding assays to assess ability to inhibit Bcl-3 complex

  4. -NF-kB activity as an indicator of Bcl-3 bioactivity

  5. -Cell migration assay as an indicator of metastatic potential

  6. Compounds tested in vivo;

  7. -In a mouse model with a human breast cancer cell line

  8. -Development of mouse models equivalent to clinical trial platforms

  9. -Compounds sent for PK evaluation in rodent models

  10. Further analogues synthesized based on results

  11. Several non-breast cancer cell lines tested, to broaden patent scope to other cancer types.


Seeking to identify a clinical candidate


  1. Compounds sent for in vivo PK/PD evaluation

  2. Selection of the clinical candidate(s)


Preparing for clinical trials


• Manufacture of the clinical candidate under GMP manufacture, and pre-clinical toxicology testing prior to submission of the application for first in man clinical trials.

The last of the research milestones is due once an Investigational New Drug (IND) application is made seeking approval for clinical trials.

An indicative projected timeline for the research programme outlined above is set out below.