|
|
|
|
||
|
| ||
|
|
Home > Vascular Targeting > Combretastatin > Clinical Trial Results Clinical Trial Results OXiGENE has completed three Phase I clinical trials of Combretastatin A4 Prodrug including approximately 100 patients in the United States and Europe. Although Phase I is early in the developmental life of any potential drug, the data from these three Phase I trials demonstrate a link between the compound and significant reduction of blood flow to tumors. The data from these studies are promising because they support the proof of principle and result in a clinical response that is rarely seen in Phase I trials. Phase I clinical trials are designed to investigate a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects. Because the dosage ranges vary greatly from too low to too high and optimal treatment regimes have yet to be determined, it is very rare to achieve notable clinical results from these trials. Nevertheless, the Combretastatin A4 Prodrug Phase I trials included several significant clinical findings. The completed Phase I trials place Combretastatin A4 Prodrug and OXiGENE further along the drug development pathway than companies such as AstraZeneca and Aventis, which are both in various early stages of research into vascular targeting. Combretastatin is the first vascular targeting agent to be tested in a human trial in the United States. Below is a summary of Phase I clinical trial research findings. CA4 Prodrug completed three Phase I clinical trials, all with promising results:
Abstracts
Ireland Cancer Center Clinical Trial On October 31, 2001, OXiGENE announced the successful completion of its Phase I U.S. trial of Combretastatin for the treatment of solid cancer tumors. The trial, lead by Scot Remick, M.D., Associate Professor of Medicine at the Ireland Cancer Center, University Hospitals of Cleveland, Case Western Reserve University School of Medicine in Cleveland, Ohio, enrolled a total of 25 patients and generated statistically significant findings demonstrating Combretastatin's ability to successfully reduce the blood flow that supplies malignant tumors with nutrients and oxygen as well as removes waste products that are toxic to the tumor cells. The trial demonstrated that Combretastatin A4 Prodrug can be given safely at doses that significantly diminish the blood flow to malignant tumors, as evidenced by MRI (magnetic resonance imaging). Researchers confirmed a significant reduction in the tumor blood flow in several patients 4-6 hours following infusion of CA4 Prodrug. One patient experienced complete eradication of his thyroid cancer while enrolled in the trial. In May of 2001, OXiGENE announced final data from its Phase I U.K. clinical trial of CA4 Prodrug at the annual meeting of the American Society of Clinical Oncologists. In that study, which involved 34 patients, CA4 Prodrug caused a meaningful reduction in malignant tumor blood flow in several cases. The dose-limiting toxicity in the U.K. study was reversible ataxia. One patient experienced a significant reduction in tumor size while enrolled in the trial. The patient’s improvement could not be clinically assessed but it was noted by physicians and continued for approximately 8 months. The patient’s disease ultimately worsened. University of Pennsylvania Clinical Trial The University of Pennsylvania conducted a Phase I trial, involving 37 patients. Six patients in this trial exhibited clinically relevant degrees of disease stabilization. The dose-limiting toxicity in the University Pennsylvania trial was tumor pain as assessed by the investigator. |
| |||||
 | | | | | | | ||
Last revised on 1/14/03
