• BioMarin Pharmaceutical Inc., of Novato, Calif., said the first patient has been treated in the second, company-sponsored Phase II study with oral 6R-BH4 for symptomatic peripheral arterial disease. Commonly known as tetrahydrobiopterin, 6R-BH4 is an essential enzyme cofactor that is involved in the production of nitric oxide, a molecule that has been shown in clinical studies to play a key role throughout the cardiovascular system, including regulation of endothelial function. The company expects to announce data from this study in the first half of fiscal year 2008.

• Enzon Pharmaceuticals Inc., of Bridgewater, N.J., submitted an investigational new drug application for its hypoxia-inducible factor 1alpha (HIF-1alpha) antagonist, a potential target for cancer. Enzon licensed the product from Santaris Pharma A/S, of Copenhagen, Denmark, in July 2006, along with a survivin antagonist and six additional RNA antagonist candidates, all directed at cancer targets. (See BioWorld Today, July 28, 2006.)

• Genentech Inc., of South San Francisco, disclosed positive results from a randomized Phase II study comparing pertuzumab plus gemcitabine (Gemzar, Eli Lilly and Co.) to gemcitabine alone in women with platinum-resistant ovarian, primary peritoneal, or fallopian tube cancer. Data from the study will be submitted for presentation at an upcoming medical meeting. Pertuzumab or 2C4, a humanized antibody formerly known as Omnitarg, is the first in a new class of investigational agents known as HER dimerization inhibitors.

• Hypnion Inc., of Lexington, Mass., said its insomnia drug candidate, HY10275, met the primary and secondary endpoints in an initial Phase II study evaluating doses of 1 mg and 3 mg in adults with transient insomnia. Results from the 52-patient trial showed that the drug demonstrated statistically significant improvements in wake after sleep onset, which decreased in a dose-dependent manner by 62 minutes for 3 mg and 35 minutes for 1 mg. Secondary endpoints included latency to persistent sleep, and patients reported no next-day impairment or residual fatigue following treatment. HY10275 is a dual-acting H1/5HT2A compound developed using Hypnion's SCORE-2004 technology.

• Tengion Inc., of East Norriton, Pa., started a Phase II multicenter study with its autologous urinary neo-bladder construct. The study is being conducted in pediatric patients with spina bifida who have failing bladders that predispose them to a risk of kidney failure and incontinence even when they receive optimal medical therapy. Each construct consists of a biodegradable scaffold seeded with urothelial and smooth muscle cells cultured by Tengion scientists.