Cytogen antibody gets FDA trial OK

Cytogen expects to begin the first US phase I clinical trial of CYT-500 in patients with hormone-refractory prostate cancer subject to institutional review board approval at the planned clinical site.

CYT-500 uses the same monoclonal antibody from Cytogen’s Prostascint (capromab pendetide) molecular imaging agent, but is linked through a higher affinity linker than is used for Prostascint to a therapeutic as opposed to an imaging radionuclide. This novel product candidate is designed to enable targeted delivery of a cytotoxic agent to prostate-specific membrane antigen (PSMA)-expressing cells.

In other news, Cytogen posted its Q1 2006 results, which included double-digit year-over-year sales growth for both Prostascint and Quadramet.

The company said total product revenues for the first quarter of 2006 were a record $4.4 million compared to $4 million in the same period in 2005 and $4.2 million in the fourth quarter of 2005, representing 12% revenue growth year-over-year and 5% sequential growth from the fourth quarter of 2005.

Cytogen’s gross margin for Q1 2006 improved to 46% compared to 39% for the same period in 2005. However, the company reported a net loss of $7.7 million in Q1 2006, compared to $6.6 million for the same period in 2005. The increase in net loss was primarily driven by a $1.2 million expense related to the production of clinical materials to support upcoming studies of CYT-500, a charge of $631,000 related to the increase in the fair value of the warrant liability, and the recognition of $462,000 of share-based compensation expenses.