• Generon Corp. Ltd., of Shanghai, China, said it started a Phase II trial of F-627, a newer-generation recombinant human granulocyte colony-stimulating factor, in women with breast cancer receiving myelotoxic chemotherapy. The study will enroll about 200 patients, with the primary objective of evaluating safety and efficacy of various once-per-cycle dosing, compared to standard dosing of Neulasta (pegfilgrastim, Amgen Inc.).

• Isis Pharmaceuticals Inc., of Carlsbad, Calif., said it started a Phase II study evaluating ISIS-APOCIIIRx in patients with hypertriglyceridemia. The randomized, dose-response study is expected to enroll about 100 patients with very high triglycerides and will test the drug, an inhibitor of apolipoprotein C-III (apoC-III), as a monotherapy and in combination with fibrates. The endpoints include measurements of triglycerides both before and after eating and apoC-III levels in blood. APOCIIIRx is the third drug to advance into Phase II testing from Isis' cardiovascular franchise.

• Raptor Pharmaceutical Corp., of Novato, Calif., said findings from the firm's Phase III trial published in the Clinical Journal of the American Society of Nephrology showed that its delayed-release formulation of cysteamine bitartrate (RP103), taken every 12 hours, was noninferior to available immediate-release cysteamine bitartrate treatment (Cystagon), which is taken every six hours, for maintenance of white blood cell cysteine levels in patients already well controlled on Cystagon. The company reported top-line data from the Phase III program last year. RP103 is under review in both the U.S. and Europe. (See BioWorld Today, July 26, 2011.)

• TapImmune Inc., of Seattle, said the Mayo Clinic received investigational new drug application allowance for a Phase I trial of the company's HER-2/neu vaccine in breast cancer patients who finished standard Herceptin (trastuzumab, Roche AG)-based therapy and are at high risk of disease recurrence. The primary endpoints will be safety and immunogenicity. TapImmune is sponsoring the study and has an exclusive option to license the antigen technology at the end of Phase I.