The Virtual Window: Clinical Trial Reports--March 2007

By Elizabeth Mills and Nick Rose
Published: Monday, Aug 16, 2010
The Clinical Trial Report

%u25BA PHASE I

BiPar Sciences Recruiting for a Phase 1b Study of BSI-201 Combined With Chemotherapy

On January 4, BiPar Sciences, Inc., announced a phase Ib study of the poly-ADP-ribose polymerase (PARP) inhibitor BSI-201 for the treatment of solid tumors. This study, which is an outgrowth of the ongoing phase I assessment of BSI-201 initiated last year, will study the drug used in combination with various chemotherapeutic agents. The phase I study continues in its goals of confirming the drug’s safety and establishing dosage tolerance. Preclinical studies showed BSI-201’s efficacy in targeted tumor cell death. The drug appears to be effective against a range of tumor types and is well-tolerated by patients.

Thomas F. White, president and CEO of BiPar, reported that, “The knowledge gained from this new combination phase 1b study, from our ongoing monotherapy phase 1 study and from our proprietary genomic data, will lead into a robust BSI-201 phase 2 program.” The three sites participating in the phase Ib study are Philadelphia’s Fox Chase Cancer Center, the Institute for Drug Development (San Antonio), and the Barbara Ann Karmanos Cancer Institute (Detroit).

                                                                                                                                                                                                   —Elizabeth Mills

Targepeutics Expects to Begin Clinical Trials of GB13 in 2007

Clinical trials of GB13, a molecular-targeted therapy for cancer, are expected to begin in 2007, according to a January 4 announcement by Targepeutics. The company develops mutated IL-13-based compounds that specifically target the IL-13 cell receptors found on cancer cells but do not bind to normal cell receptors. These mutated compounds are then combined with cellular toxins to create what the company’s website refers to as a “smart bomb” to attack cancer cells. GB13 is one of several such compounds under development.

Unlike existing agents, which affect the IL13Ra1-involving IL-13 binding site, GB13 is specific to IL13Ra2, a biomarker expressed in numerous, including ovarian and prostate cancers. GB13 is composed of genetically engineered mutant of IL-13 combined with PE4E, a derivative of Pseudomonas exotoxin A.

                                                                                                                                                                                                —Elizabeth Mills

Roger Williams Medical Center is Recruiting Patients for a Phase I/II Study of Chemotherapy Followed by Stem Cell Transplantation and Immunotherapy for Stage IIIB or Stage IV Breast and Other Solid Tumors


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