Threshold Pharmaceuticals Inc. presented additional data from a Phase III trial showing glufosfamide was active in certain subgroups of patients with metastatic pancreatic cancer. Data were presented at the European Cancer Conference annual meeting in Barcelona, Spain.

The Redwood City, Calif., company in February disclosed initial data from the Phase III trial of glufosfamide. Results showed that overall survival in patients with metastatic pancreatic cancer who had relapsed after gemcitabine chemotherapy was 18 percent higher in the glufosfamide arm than in those receiving best supportive care, but the result did not reach statistical significance. (See BioWorld Today, Feb. 28, 2007.)

New analysis showed that, in general, patients with better prognosis showed a greater treatment effect than those with poorer prognosis. Surprisingly, however, a subgroup of diabetic patients taking glucose-lowering agents (primarily sulfonylureas) indicated much improved survival with glufosfamide, 13.7 months vs. 2.4 months, Threshold said.

The subgroup analysis suggests that glucose-lowering agents may preferentially enhance the efficacy of glufosfamide in those patients. Glufosfamide combines the active part of ifosfamide, from the chemotherapy class of alkylators, with a glucose molecule.

Threshold said it believes glufosfamide should have a role in the treatment of pancreatic cancer, and plans to explore the best options forward.

In other news from the ECCO meeting:

• MediciNova Inc., of San Diego, presented positive findings from a Phase I study of MN-029, a vascular disrupting agent. The open-label, dose-escalating study in 34 patients in the U.S. showed a statistically significant correlation (p=0.001) between increasing exposure to MN-029 and Ktrans, a contrast-enhanced MRI imaging marker of tumor blood flow and vascular permeability. MN-029 is designed to selectively disrupt newly formed tumor blood vessels, shutting down tumor blood flow and causing central necrosis of solid tumors.

• Cell Therapeutics Inc., of Seattle, said preliminary data from a Phase I dose-escalation study of brostallicin in combination with cisplatin showed the dose-limiting toxicities to be febrile neutropenia and fatigue. Prolonged disease stabilization was seen in patients with advanced solid tumors who had relapsed after prior treatment regimens. Of the 21 patients treated, 14 experienced disease stabilization, with seven experiencing disease stabilization for more than 18 weeks (18-31 weeks). Brostallicin is a second-generation DNA minor groove binder, believed to interfere with DNA division and lead to tumor cell death. CTI got brostallicin through its acquisition of Systems Medicine Inc. in July.

• Nektar Therapeutics Inc., of San Carlos, Calif., said preclinical data on NKTR-102 (PEG-irinotecan) demonstrated statistically significant dose-related suppression of tumor growth in an irinotecan-resistant mouse xenograft model. Further, NKTR-102 displayed extended and unique pharmacokinetics that resulted in greater and sustained exposure to both irinotecan and its active metabolite, Nektar said. The product is in Phase I development.