West Coast Editor

With a Phase III study already under way to evaluate one of its monoclonal antibodies, CeaVac, Titan Pharmaceuticals Inc. said a Phase II study is starting to measure it with a second, TriAb, in combination against Dukes’ D colorectal cancer in patients with resected liver metastases.

The name of the cancer derives from a staging system developed by British pathologist C.E. Dukes. “D,” the most severe category, means the cancer has gone beyond the colon lining (“A”), muscle layer (“B”) and lymph nodes (“C”), into another area of the body.

About 60 percent of patients with Dukes’ D colorectal cancer develop liver tumors, and typically relapse within two years after surgery, with no further therapy available for them.

Designed to assess the safety and preliminary efficacy of the two antibodies, the study is being conducted by The Cancer and Leukemia Group B, a national clinical research group, with funding provided by the National Cancer Institute, according to a press release. CALGB includes 29 university medical centers, more than 185 community hospitals and about 3,000 physicians.

South San Francisco-based Titan itself is conducting a randomized, double-blind, placebo-controlled Phase III study of CeaVac for the same indication, with more than 620 patients enrolled at more than 50 sites in the United States and Europe.

CeaVac works by mimicking the carcinoembryonic antigen, and TriAb mimics the human milk fat globule antigen, both found in high concentrations in colorectal cancer cells.

The NCI also is funding a Phase II study of CeaVac and TriAb in patients with non-small-cell lung cancer that is being conducted by another government sponsored clinical cooperative group, the Radiation Therapy Oncology Group.

Separately, Titan last month got a $2 million milestone payment from Schering AG, of Berlin, Titan’s worldwide corporate partner for Spheramine for Parkinson’s disease, with which Titan completed a 12-month, Phase I/II study. Data will be presented later this year.

Spheramine consists of retinal pigment epithelial cells adhered to microscopic carriers and implanted in the central nervous system to produce dopamine, in which Parkinson’s patients are deficient.

Company officials could not be reached for comment.

Titan’s stock (AMEX:TTP) closed Friday at $6.30, down 20 cents. The firm’s shares began to slide last summer, falling 56 percent to close at $11.95, after the company said Zomaril (iloperidone), its schizophrenia drug partnered with Basel, Switzerland-based Novartis Pharma AG, would require more trials, which means a year’s delay in regulatory filings. Analysts estimated approval would not come until sometime in 2004. (See BioWorld Today, July 25, 2001.)