Pharmicell said that it has filed an investigational new drug application to conduct the clinical trials of Cellgram-DC, a prostate cancer treatment, to the Ministry of Food and Drug Safety.
The clinical trial will evaluate the safety, tumor-specific immune response and efficacy of Cellgram-DC in patients with metastatic castration-resistant prostate cancer.
“Myeloid dendritic cell, which is the major component of Cellgram-DC, is the most common dendritic cells in living organisms,” a company official said. “We expect that the treatment will provide a new therapeutic strategy for anticancer immune cell therapy.”
Prostate cancer is the most common male cancer worldwide, with 1.1 million new cases and 307,000 deaths reported in 2012.
Of those diagnosed with prostate cancer, 20 to 30 percent of patients fail the primary treatment. Although some of the patients respond to the second-line treatment, most of their cancers develop into metastatic castration-resistant prostate cancer.
The median survival rate for patients with metastatic castration-resistant prostate cancer is 12.2 to 21.7 months. While secondary therapies such as hormone control, chemotherapy, bisphonates, and experimental agents are available, they are known only to extend the survival rate by two to four months.