• Affymax Inc., of Palo Alto, Calif., and Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, said Affymax has dosed the first patient in the Phase III clinical program of its lead investigational therapy Hematide for anemia in chronic renal failure patients. The Hematide Phase III program, involving about 2,200 chronic renal failure patients, consists of four open-label, randomized-controlled clinical trials in the U.S. and Europe, including two trials in patients on dialysis and two trials in patients not on dialysis. The trials in nondialysis patients, called PEARL 1 and PEARL 2, will evaluate the safety and efficacy of Hematide compared to darbepoetin alfa in correcting anemia and maintaining hemoglobin levels over time. In dialysis patients previously-treated with EPO, the trials, called EMERALD 1 and EMERALD 2, will evaluate the safety and efficacy of Hematide and its ability to maintain hemoglobin levels in a corrected range compared to epoetin alpha or epoetin beta when patients are switched from either of these epoetins to Hematide.

• Momenta Pharmaceuticals Inc., of Cambridge, Mass., has treated the first patient in a multicenter Phase II study of the intravenous formulation of M118, its rationally engineered anticoagulant. The study will treat patients with stable coronary artery disease undergoing percutaneous coronary intervention. A recently completed Phase I study found M118 to be safe and well tolerated, and it produced rapid, measurable, dose-dependent increases in anticoagulant activity in a linear manner across all study cohorts.

• Nile Therapeutics Inc., of Berkeley, Calif., reported positive results from a Phase Ia clinical study of CD-NP, its selective NPR-B agonist being developed for the treatment of heart failure. Data demonstrated that CD-NP can be safely administered and elicits pharmacological and clinical effects consistent with the proposed mechanism of action. Additional Phase I trials are planned in heart failure patients to determine therapeutic dose range for diuresis, natriuresis and cardiac filling pressure reducing effects, while maintaining systemic blood pressure and preserving renal function.

• Novacea Inc., of South San Francisco, has initiated a randomized, placebo-controlled, multicenter Phase II trial of Asentar (DN-101) in patients with advanced pancreatic adenocarcinoma. The trial, involving about 132 subjects, will evaluate the effect of weekly Asentar combined with weekly gemcitabine plus or minus daily erlotinib (Tarceva) in the initial treatment of advanced pancreatic adenorcarcinoma. The primary endpoint is the six-month survival rate, with secondary endpoints of objective response rate, duration of progression-free survival and overall survival. Asentar is the company's lead investigational product and also is in a Phase III trial for advanced prostate cancer.

• Pro-Pharmaceuticals Inc., of Newton, Mass., reported that three of seven (43 percent) evaluable patients in its Phase II colorectal cancer trial have experienced tumor shrinkage of greater than 30 percent, a partial response according to Response Evaluation Criteria for Solid Tumors. In addition, none of the patients have experienced hematological or gastrointestinal severe adverse events (SAEs) of grade 3 or higher. SAEs generally result in life-threatening events, inpatient hospitalization, persistent or significant disability, or death. The Phase II trial is for first-line treatment of patients with metastatic, unresectable colorectal cancer who are unable to tolerate intensive chemotherapy. The two-stage study is an open-label, multicenter trial with a regimen of Davant in combination with 5-Fluorouracil, Leucovorin and Avastin.