GTI-2040 is a highly specific inhibitor of R2, a component of ribonucleotide reductase, which can behave as a malignant determinant for cancer growth and metastasis, and is abnormally elevated in renal cell carcinoma and many other cancers.
All 33 patients entering the study had advanced disease with multiple metastatic sites, with or without prior removal of the primary kidney tumor. However, more than half (52%) of the patients on the recommended dose exhibited disease stabilization or better, including one confirmed partial response.
Durable tumor reductions observed at the recommended dose included 23% reduction of tumor burden in a patient with a disease stabilization of ten months duration, and 39% reduction of tumor burden in a patient with a partial response to treatment of eight months duration. Other durable disease stabilizations of four to nine months duration were also observed.
“We are pleased that the final results for the phase II clinical trial have now confirmed the promising interim findings presented at the ENA meeting in September 2004,” said Dr Jim Wright, Lorus’ CEO.
Wright also noted that, in addition to the strategy of combination with chemotherapeutic agents to treat resistant kidney cancer patients, Lorus plans to pursue a clinical development program to evaluate GTI-2040 in combination with interferon immunotherapy for treatment of early diagnosed kidney cancer requiring systemic therapy.