• BioMarin Pharmaceutical Inc., of Novato, Calif., said a literature review and meta-analysis of blood phenylalanine levels and clinical outcomes in phenylketonuria were published in Molecular Genetics and Metabolism. The review of 40 studies confirmed a significant correlation between blood Phe level and IQ levels in PKU patients and supports the use of blood Phe levels as a predictive biomarker for IQ in clinical trials. BioMarin is developing Kuvan (sapropterin dihydrochloride) for treating PKU.

• Gene Express Inc., of Toledo, Ohio, said its molecular diagnostic test for lung cancer demonstrated high levels of accuracy in a trial. Gene Express and colleagues from the University of Toledo have identified a panel of 15 genes that could serve to predict cancer. In a study of 49 subjects, investigators were able to correctly identify the individuals with cancer 96 percent of the time.

• Genmab A/S, of Copenhagen, Denmark, amended the design of its ongoing pivotal study of ofatumumab (HuMax-CD20) in rituximab-refractory follicular non-Hodgkin's lymphoma to a single-arm trial that now will include about 81 patients. All patients will receive one infusion of 300 mg of ofatumumab followed by seven weekly infusions of 1,000 mg of ofatumumab. The original study design included 162 patients, who would have received one infusion of 300 mg of ofatumumab followed by seven weekly infusions of either 500 mg or 1,000 mg of ofatumumab. The product is being developed in collaboration with London-based GlaxoSmithKline plc.

• Introgen Therapeutics Inc., of Austin, Texas, said a new data analysis from multiple Phase II studies showed a statistically significant correlation between the abnormal p53 biomarker and tumor response after treatment with Advexin in patients with head and neck, lung, prostate and Li-Fraumeni syndrome cancers. The company plans to use the biomarker findings in ongoing analyses of its randomized Phase III trial comparing Advexin therapy to methotrexate for the treatment of recurrent head and neck cancer.

• Palatin Technologies Inc., of Cranbury, N.J., said it achieved positive results from an at-home Phase II trial evaluating bremelanotide for the treatment of female sexual arousal disorder. The double-blind, placebo-controlled study enrolled 76 premenopausal and 87 postmenopausal women. Bremelanotide-treated postmenopausal women showed statistically significant improvements, compared to baseline and placebo, in desire and arousal success rates, and overall satisfaction at one and two months. Premenopausal women showed statistically significant improvements vs. baseline in the same endpoints. Differences in that group vs. placebo were not statistically significant because the placebo responses were themselves statistically significantly vs. baseline, Palatin said. It said future studies are warranted, although dose-ranging studies at 10 mg and lower will be necessary to improve the drug's benefit/risk ratio.

• Pharmacopeia Inc., of Princeton, N.J., said a Phase I trial in healthy volunteers confirmed the ability of PS433540 (DARA) to block the angiotensin II response. The study showed that all doses of PS433540 compared with placebo produced a statistically significant (p<0.01) inhibition of the expected AII-induced increase in blood pressure. Additionally, the findings showed the 250-mg and 500-mg doses of PS433540 were at least as effective in blocking the AII response as irbesartan, an angiotensin receptor blocker used for treating hypertension.