Our Planned Clinical Trials
Our initial strategy is to conduct two Phase II clinical trials to identify the genomic signature of Picoplatin response in patients with squamous
cell carcinoma of head and neck (SCCHN) and colorectal cancer (CRC), and the potential of these signatures to increase objective response rate (ORR);
a measure of how tumors react to treatment.
These studies will be performed with “second line patients”-- patients that have already failed one previous treatment.
Our primary endpoint in these trials is the generation of specific genomic signatures of drug response.
Our secondary endpoint is to demonstrate expected increase in ORR (Overall Response Rate) in groups of patients selected as having “positive”
response signatures (i.e., a genomic signature pointing to a higher likelihood of response to Picoplatin treatment).
The diagram below represents the general structure of our proposed Phase II trials. The blue boxes represent two consequent cohorts of patients
planned for the studies; the gray arrows represent the major steps of the studies (drawn to scale to provide a chronology of each activity);
and the green boxes at the bottom of the diagram highlight the endpoints of these studies.
Following the completion of our Phase II trials,, we plan to conduct a randomized Phase III study
in which the genomic signatures will be used as a key patient inclusion criterion.
This “prospective” use of genomic signatures (i.e., using signatures to determine, before treatment, the patients who are more likely to respond to Picoplatin) in the Phase III study is expected to produce a statistically significant increase in the overall survival (known as OS).
The final decision on which particular cancer indication will be the focus for our Phase III study will depend on the results of our Phase II trials as well as our discussions with FDA.
The diagram below sets forth, in simple terms, the general structure of our proposed Phase III trial.
The blue arrows represent the two parallel arms of the study (the Picoplatin arm as well as the control arm); the gray arrows represent the major steps of the study (drawn to scale to provide a chronology of each activity);
and the green box on the right side of the blue arrows represent the anticipated endpoints of these studies.