• Acorda Therapeutics Inc., of Hawthorne, N.Y., completed enrollment in its Phase III trial of Fampridine-SR in multiple sclerosis. That 240-patient trial is designed to evaluate the drug's efficacy in improving walking ability. Data are expected in the second quarter of 2008.

• Alpharma Inc., of Bridgewater, N.J., reported positive results from its 500-patient, pivotal Phase III trial of ALO-01, an abuse-deterrent, extended-release opioid, which demonstrated significant pain relief, meeting the primary endpoint defined in a special protocol assessment agreed to by the FDA. ALO-01 was created using Alpharma's technology, which combines an extended-release opioid with a sequestered core of antagonist naltrexone in a single dosage form so that, when taken as directed, the naltrexone remains sequestered and the patient can achieve pain relief similar to morphine sulfate extended-release capsules. Results from the Phase III trial are expected to serve as the basis for the firm's new drug application, anticipated in 2008.

• Crucell NV, of Leiden, the Netherlands, reported results from an Indian Phase Ib study of its rabies monoclonal antibody cocktail indicating that the treatment is well tolerated, provides the expected neutralizing activity and can be safely administered in combination with a rabies vaccine. In the first part of the study, rabies virus neutralizing activity could be demonstrated at both levels of the product administered, and in the second part, in which the rabies antibody cocktail was given in combination with a rabies vaccine, all volunteers seroconverted within 14 days upon initiation of treatment. Results were presented at the tropical medicine meeting in Bangkok, Thailand.

• Shire plc, of Philadelphia, said a study published in Biological Psychiatry showed that Vyvanse (lisdexamfetamine dimesylate), a prodrug stimulant for attention deficit hyperactivity disorder, provided significant efficacy in children for up to 12 hours. Data also showed that the drug demonstrated low interpatient variability of measured pharmacokinetic parameters, as reported by the coefficient of variance. The Phase II study tested Vyvanse and Adderall XR in children, ages 6 to 12, compared to placebo.

• StemCells Inc., of Palo Alto, Calif., said the first patient to receive a transplant of HuCNS-SC cells (purified human neural stem cells) has completed the Phase I trial. That patient, who was transplanted in November 2006, finished the 12-month period of immunosuppression and follow-up and has undergone the last of the tests and observations required by trial protocol. The patient subsequently has been enrolled, as planned, in a separate, long-term follow-up study, designed to monitor patients over a four-year period. To date, five of the six planned patients have been transplanted, and so far, no safety issues have been identified to prevent transplantation in the sixth patient, expected in January.

No Comments