Pharmacyclics Publishes Interim Data of Xcytrin in Advanced Renal Cell Carcinoma

Pharmacyclics has announced the publication of interim data from a Phase II clinical trial of Xcytrin (motexafin gadolinium) injection, the company's lead anticancer agent, for the treatment of patients with advanced, recurrent renal cell carcinoma.

Researchers at the Methodist Hospital Research Institute in Houston measured the clinical benefit rate and tumor response rate in 22 metastatic renal cell cancer patients with treatment-refractory disease who were treated with Xcytrin daily for five days every two weeks until disease progression.

So far, the study has enrolled 22 patients, including 17 males and five females with a median age of 63 years and who have failed a median of two prior therapies. Five of the patients enrolled had one site of metastasis, eight enrolled had two sites of metastases, and nine enrolled had more than two sites. These clinical features are known to be associated with poor prognosis. Following treatment with Xcytrin, five patients have exhibited clinical benefit, defined as stable or regressing disease, through at least six months of follow-up, with two of these patients continuing on treatment and exhibiting clinical benefit through nine months. Three patients showed tumor responses including complete regression of pulmonary metastases.

Side effects of Xcytrin therapy were mild and included fatigue, headache, nausea and blistering on the fingers. Each of these side effects was observed in more than 25 percent of patients.