Companion Diagnostics using TherapySelect's Diagnostics

Unsuccessful clinical trials are the most expensive and latest obstacle in drug development. The success of clinical trials can be significantly increased by using diagnostics to identify patients susceptible for the drug. By using our diagnostic technology (CTR-Test®) we want to make the drug development more successful.

Personalized medicine can start immediately during drug development. By combining the diagnostic tools already with the drug during clinical trials, one increases the
success of the clinical development and makes the drug more efficient if it is only administered to patients which have an increased susceptibility towards the drug.
After getting an approval for the drug one could reduce the costs for the diagnostics by identifying molecular marker for the particular drug, by using the CTR-Test®-Technology as a reference (with or without further clinical data).

Clinical trials represent a great obstacle for the development of new drugs, because of the immense costs and the low success rate. Only 1 out of 10 drugs successfully pass through the clinical development. 80% of drugs are excluded in phases II in clinical trials.

Reasons are:

  1. strategic reasons (e.g. the difference between established drugs and the new drug are not big enough),
  2. there are high security risks and
  3. the effectiveness is not high enough. This means that the increase of effectiveness of the new drug compared with a placebo, another drug or an additional therapy is statistically not significant enough. The development of drugs including the clinical phases are very expensive. Therefore the pressure to pharmaceutical companies is high to succeed and the companies only concentrate on drugs which show a high potential, although drugs which might be much more effective for a subpopulation are neglected.

In this situation our diagnostics could be an advantage. The success rate of clinical trials can be increased, if the susceptible patient population for a drug is identified in advance.

The following diagram shows the advantage of our diagnostics for clinical trials. Half of the drugs which fail in phase II could be successful if the susceptible patient population for the new drug is identified.

Verbesserung der Erfolgsraten von klinischen Studien mit Hilfe von Companion Diagnostics
TherapySelect offers interested pharmaceutical partners our diagnostc tools to evaluate the susceptibility of patients to the drug. This can be done either in a phase II or phase III study. The project could consist of 3 phases.
  1. phase: The CTR-Test® needs to be calibrated for the drug. This needs to be done with fresh tumor samples. One would need about 20 patient to find the right drug concentration in the assay and about 30 patients for the actual calibration.
  2. phase: The clinical trial (either phase II or phase III) can be done together with the diagnostic assay. The CTR-Test® can either be used as a backup system to show that in case of an unsuccessful trial, that the drug used in a preselected population can be effective. Or the assay can be used directly as a stratification tool to find the population which can be included into the trial.
  3. phase (optional): Since the CTR-Test®-Technology is an expensive diagnostic tool. One can use the CTR-Test® to identify molecular markers which can be used instead for a selection, if it is possible.

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