Endocyte Inc has announced the initiation of a randomized phase-II clinical study of the company's investigational drug EC145 in women with platinum-resistant ovarian cancer. The phase-II trial, also called the 'Precedent study', will evaluate the efficacy and safety of EC145 when administered in combination with pegylated liposomal doxorubicin (PLD). PLD is widely used as a standard therapy for women with platinum-resistant ovarian cancer.
The efficacy and safety of the combination of EC145/PLD will be compared to treatment with PLD without EC145. Ovarian cancer is the fifth most common cancer among women in the United States and the leading cause of death due to cancer of the female reproductive system. The Precedent study will enrol 122 subjects and involve more than 50 clinical centers in the US, Canada, and Europe.
EC145 links a very potent anticancer drug to the vitamin folate, which is required for cell division. Rapidly dividing cancer cells over-express folate receptors to capture enough folate to support cell division. By combining a chemotherapy drug with folate, EC145 targets cancer cells while avoiding normal cells. This targeted approach is designed to provide treatment with more potent drugs with lower toxicity.
In addition to EC145, patients in the Precedent trial will also be treated with a new molecular imaging agent called EC20 developed by Endocyte. By targeting folate receptors, EC20 imaging agent allows clinicians to identify tumours that over express the folate receptor. Using EC20, doctors may be able to identify, in advance, those patients who will benefit from EC145 therapy.
According to Dr Wendel Naumann of the Blumenthal Cancer Center, Carolinas Medical Center and principal investigator for the Precedent study, "Patients with advanced, platinum resistant, ovarian cancer are in need of therapy that does not result in significant toxicity. The earlier clinical studies of EC145 were encouraging because they indicated that clinicians could use EC20 to identify women whose tumours expressed the molecular target of EC145. Therapy with EC145 might benefit these patients without causing significant additional toxicity."
"The start of the Precedent study is another important validation of Endocyte's promising DGS technology platform," said Dr Richard Messmann, Endocyte's vice president for medical affairs. "This also represents an important milestone in Endocyte's efforts to develop a range of new drugs and predictive medicine tools to treat cancer and other serious diseases in the years ahead."
Endocyte is a privately-held biotechnology company with headquarters in the Purdue Research Park of West Lafayette, IN. Based on the applications of Endocyte's advanced proprietary Drug Guidance System (DGS), the company is working to develop new drugs and diagnostic agents to treat many types of cancer and other serious diseases.