Cytogen’s Quadramet wins FDA nod

Monoclonal antibody developer Cytogen of Princeton, NJ, has received the Food and Drug Administration's go-ahead to market its Quadramet cancer therapy agent for relieving pain in patients whose cancer has spread to the bone. Quadramet is indicated in patients with osteoblastic metastatic bone lesions, which can be caused by prostate, bone, or breast cancer.

Quadramet will be marketed in the U.S., Canada, and Latin America by Du Pont Merck Radiopharmaceuticals, with shipments scheduled to begin this quarter. The news of the FDA's action caused Cytogen's stock to surge 56, or 11%, to end at $5.81 on March 31, the day the news was announced.

In other Cytogen news, the company said that it has begun phase I clinical trials investigating the use of Quadramet for treating patients with refractory rheumatoid arthritis. The study will be conducted at the University of Iowa and will enroll about 30 patients.

Another Cytogen technology, prostate specific membrane antigen (PSMA), has shown promise in preliminary research as a possible vaccine to fight prostate cancer. Cytogen has licensed PSMA technology to a company called Prostagen, which is researching the use of immunotherapy for advanced prostate cancer.