With off-label use of Herceptin already slowly growing for early stage breast cancer patients, Genentech Inc. said two Phase III trials in that population were stopped after an interim analysis showed the drug offered benefit. (BioWorld Today)

A week after presenting positive data from an ongoing Phase II trial with CoFactor, its biomodulator to enhance 5-FU in treatment regimens for metastatic colorectal cancer, Adventrx Pharmaceuticals Inc. said the FDA cleared the way to start a Phase III pivotal trial under a special protocol assessment. (BioWorld Today)

EditorIt seemed bound to happen.Getting ready to sign a partner in Europe for Dynepo (epoetin delta), its version of erythropoietin, Transkaryotic Therapies Inc. had been bracing an eager market for data from the pivotal Phase III trial with another therapy - iduronate-2-sulfatase for Hunter syndrome, expected in the second half of 2005, with Phase I/II data due about the same time from the open-label Phase I/II trial testing of yet another enzyme-replacement therapy, GA-GCB in Gaucher's disease.

Earlier this month, powerhouse Genzyme Corp. disclosed its launch of Phase III trials with the toxin binder tolevamer for patients with Clostridium difficile-associated diarrhea - a compound that derives from the same platform that yielded Renagel, the phosphate binder approved for end-stage renal disease that pulled in $364 million in revenue last year, up 29 percent over 2003. (BioWorld Financial Watch)