MEDAREX (MEDX) announced the receipt of a Special Protocol Assessment (SPA) letter from the FDA for the initiation of a registrational clinical trial of ipilimumab (also known as MDX-010) used in combination with chemotherapy in previously untreated (first-line) metastatic melanoma patients. The SPA agreement with the FDA concerns the suitability of the trial design to support regulatory approval.

The clinical trial is expected to commence shortly and to enroll approximately 500 patients with previously untreated Stage 3 or Stage 4 metastatic melanoma. Patients will receive 10 mg/kg of ipilimumab in combination with dacarbazine, or dacarbazine alone once every three weeks for up to four doses. Subsequently, patients who have not experienced disease progression at week 24 will continue with a single dose of ipilimumab once every 12 weeks until disease progression. The study is designed to assess progression-free survival as the primary endpoint. Secondary endpoints include overall survival, progression-free survival rate at week 12, best overall objective response rate and duration of responses, and disease control rate (complete and partial responses plus stable disease).

Medarex believes that the combination of ipilimumab and chemotherapy may provide a potentially important treatment for metastatic melanoma, an area where new therapies are urgently needed.

AMGEN (AMGN) Results from a Phase 2 study presented at the 2006 European Society of Cardiology-Heart Failure (ESC-HF) have shown that, in patients with symptomatic heart failure and anemia, Aranesp® was well tolerated and effectively raised hemoglobin (Hb) (Abstract # 60734). Amgen also announced results from a prespecified pooled analysis including these data and data from a second Phase 2 study presented in March 2006 at the American College of Cardiology (ACC) Scientific Session showing that treatment with Aranesp may decrease the risk of heart failure hospitalization and all-cause mortality, and improve symptoms (Abstract #60731). These results require confirmation from a large Phase 3 randomized controlled clinical trial.