"MOZOBIL has the potential to help more patients collect more stem cells for transplant. I have a lot of hope that this drug could become a new standard in stem cell mobilization", he added.

With the combination of MOZOBIL and G-CSF, 100% of patients collected enough cells for transplant, compared to 64% of patients using G-CSF alone. Further, 84% of patients in the MOZOBIL +G-CSF study arm collected 50% more stem cells per day than patients in the G-CSF arm. Sixty percent of patients in the MOZOBIL+G-CSF arm collected the ideal amount of stem cells in two days compared to 16% in the G-CSF arm.

The study results from twenty five cancer patients show MOZOBIL in combination with G-CSF is a superior stem cell mobilization regimen compared to G-CSF alone, based on the yield of stem cells collected per day, the reduction in stem cell collection time and successful mobilization of patients who failed in the G-CSF arm. These results were statistically significant and highly skewed toward improved collection with MOZOBIL + G-CSF with a p value less than or equal to 0.001.

Data reported from this study and ongoing Phase II studies of MOZOBIL are the basis for two pivotal Phase III studies that are underway at up to 40 key transplant centers across the United States. The Phase III studies will evaluate 600 cancer patients undergoing stem cell transplantation: one study will enroll 300 patients with non-Hodgkins lymphoma and the other study will enroll 300 patients with multiple myeloma. AnorMED plans to complete Phase III patient enrolment and 3-month follow-up in 2006.

Study Design

This Phase II study was the first study to evaluate the combination of MOZOBIL and G-CSF in cancer patients requiring stem cell transplantation. The Phase II study included 25 patients, 10 patients with multiple myeloma and 15 patients with non-Hodgkin’s lymphoma. The study was designed to determine if patients who are given MOZOBIL plus G-CSF, compared to G-CSF alone, have more stem cells available for transplantation. This study also evaluated the number of stem cell collections needed to obtain the target number of stem cells required for transplantation.

Each patient served as their own control, receiving either MOZOBIL and G-CSF or G-CSF alone first. After the initial treatment, stem cells were collected from each patient followed by a 13- to 17-day wash out period which allowed for the medication to be cleansed from the patient’s system before the patient began the alternative treatment regimen in the second phase of the trial. The patient then received the alternate treatment and underwent stem cell collection again.

Patients in the study experienced few additional side effects with the combination therapy compared to therapy with G-CSF alone. Side effects related to MOZOBIL were generally very mild and transient. The most frequently reported included gastro intestinal, injection site redness and nausea.

Stem Cell Transplantation For Cancer Patients