Clinical Trials

Clinical Trial Updates

Tyrogenex* VEGFR/PDGFR (X-82) an oral angiogenesis inhibitor, is currently being studied in a Phase I First in Human clinical trial in patients with advanced cancers. Through a continuous QD dosing schedule, X-82 has been successfully dose escalated to the fourth dose level without any known toxicities or need for discontinuation. Furthermore, patients in the first two cohorts have been on treatment for greater than 8 weeks without disease progression. Further dose escalation is ongoing.

To learn more about the clinical trials that are underway at Xcovery please visit www.clinicaltrials.gov or call (561) 835-9356.

* Tyrogenex is a part of the Xcovery Group of companies, founded by Biocatalyst International

Clinical Trials

Clinical trials are designed to advance scientific knowledge while protecting trial subjects. Scientific researchers must follow specific guidelines to ensure patients’ safety and privacy.

Before a new treatment is tested in patients, investigators conduct studies in research labs, often performing experiments in animal and human cells. This is usually followed by thorough testing in animals. If this research is successful, the FDA can approve the treatment for testing in humans.

Three Phases

Most clinical research that involves the testing of a new treatment progresses in a stepwise fashion. This allows researchers to ask and answer questions in a way that yields reliable information about the treatment and protects the patients.

Clinical trials are usually classified into one of three phases:

  1. Phase I trials are the first step in testing a new treatment in humans. In these studies, researchers may evaluate how a new drug should be given, how often, and what dose is safe. A phase I trial usually enrolls only a small number of patients.
  2. Phase II trials focus on evaluating how well the new treatment works. They also continue to test the safety of the treatment.
  3. Phase III trials compare the results of people taking the new treatment with results of people taking standard treatment. Investigators usually assign participants to the standard treatment group or the new treatment group at random (called randomization). Phase III trials often enroll large numbers of people and may be conducted at many doctors’ offices, clinics, and health centers nationwide.