• Avicena Group Inc., of Palo Alto, Calif., said data reported at the Academic Society's Annual Pediatric Neurology Meeting in Toronto showed that the defective creatine transporter gene SLC6A8 is present in autistic patients. Specifically, the screening study, which was conducted in 100 male autism spectrum disorder patients between 3 and 18 years old, revealed a 1 percent incidence rate of the defective gene. Defects in SLC6A8 have been linked to mental retardation and certain learning disabilities typically characteristic of autistic patients.

• Biogen Idec Inc., of Cambridge, Mass., and Vernalis plc, of Winnersh, UK, began Phase II testing of BIIB014 for Parkinson's disease. Also known as V2006, the oral compound is an adenosine A2A receptor antagonist that may offer a non-dopaminergic therapy for Parkinson's patients. The program's initial study is a double-blind, placebo-controlled, randomized trial of single and repeated doses of BIIB014 in late-stage patients, who also will be taking their usual L-dopa therapy. The second study will be a double-blind, placebo-controlled, randomized, dose-ranging trial of BIIB014 monotherapy in early stage patients. Both studies will evaluate safety and tolerability, and secondary endpoints will include the evaluation of motor function. Biogen Idec is responsible for conducting and funding the product's development going forward, after Vernalis advanced it through Phase I. For that work, Vernalis received a $3 million milestone payment and could receive additional milestones and royalties.

• Gemin X Biotechnologies Inc., of Montreal, began a Phase I trial of GMX1777 in patients with refractory solid tumors and lymphomas. The open-label, dose-escalation study will enroll between 18 and 24 patients at a single center, where they will receive infusions of GMX1777 as a single agent in three-week cycles. The study's objectives are to determine the compound's toxicity and pharmacokinetic profile, document any antitumor activity and establish a recommended dose and schedule for Phase II testing. GMX1777, licensed from LEO Pharma A/S, of Ballerup, Denmark, is a water-soluble, intravenously administered prodrug of LEO's CHS828.

• Inspire Pharmaceuticals Inc., of Durham, N.C., said a dose-ranging, Phase II trial comparing epinastine nasal spray to placebo in patients with seasonal allergic rhinitis demonstrated dose-related effects on the primary endpoint of improvement in total nasal symptom score, with the higher dose of 0.1% achieving statistical superiority over placebo (p<0.05). The score measures runny nose, nasal congestion, itchy nose and sneezing. The 0.1% dose also produced statistically significant improvements compared to placebo on the secondary endpoints of non-nasal symptom score (itchy eyes, watery eyes and itchy throat/palate, p<0.05) and for total symptom score (total nasal symptom score plus non-nasal symptom score, p<0.05). Inspire plans to begin a required six-month nasal toxicology study of epinastine in a single animal species to support longer-term clinical trials, and meet with the FDA to discuss the program's next steps.

• ISTA Pharmaceuticals Inc., of Irvine, Calif., said preliminary Phase II/III results of bepotastine for allergic conjunctivitis demonstrated that both tested concentrations were statistically significant in the reduction of the first primary endpoint, ocular itching, when dosed twice a day, and in one concentration when dosed once a day. In addition, both concentrations and dosing regimens produced statistically significant differences in the rapidity of response and the improvement in total nasal symptoms vs. placebo. But in the second primary endpoint, ocular redness, bepotastine did not achieve statistical significance, instead showing a trend toward clinical significance. The company, which said that several ocular allergy products have received FDA approval based on data demonstrating the achievement of statistical significance and clinical success for one of the primary endpoints, ocular itching or redness, plans to meet with the agency after finalizing the data to get a handle on remaining clinical studies required for bepotastine's approval.

• MedImmune Inc., of Gaithersburg, Md., presented positive results from a prospective trial comparing Numax (motavizumab) with Synagis (palivizumab) for prevention of respiratory syncytial virus. In the Phase III study involving 6,635 pre-term infants at high risk for RSV, Numax overall demonstrated 26 percent fewer RSV hospitalizations than Synagis (p<0.01 for non-inferiority). Additionally, Numax demonstrated a statistically significant 50 percent reduction in the incidence of RSV-specific medically attended outpatient lower respiratory infections (p<0.01). MedImmune already markets Synagis. Data were presented at the Pediatric Academic Societies' annual meeting in Toronto.

• Oramed Pharmaceuticals Inc., of Jerusalem, said it began a Phase I trial in Israel to evaluate the safety of its orally ingestible soft gel insulin capsule. The trial will take place in healthy volunteers. Further details were not disclosed.