, of Amarillo, Texas, and CytoPharm Inc., of Taipei, Taiwan, said they started enrolling patients in a study of ABI's oral interferon-alpha lozenges for chronic hepatitis C virus infection. The aim of the trial is to reduce the virologic relapse rate for those patients who have completed the standard combination therapy, which consists of high-dose injectable interferon-alpha and ribavirin. The study plans to enroll 165 patients with high-risk hepatitis C viral genotype.

* Bial SA, of S. Mamede do Coronado, Portugal, said add-on treatment with the once-daily antiepileptic Zebinix (eslicarbazepine) resulted in a marked and sustained decrease in seizure frequency over the long term. Results from the one-year extension of a pivotal Phase III study were presented at the International Congress for Epilepsy in Budapest, Hungary. Patients not controlled with existing antiepileptic drugs who were given eslicarbazepine acetate as an add-on treatment experienced a mean reduction in seizure frequency of more than 61 percent. Nearly 65 percent of patients were classified as responders, meaning that they had achieved at least a 50 percent reduction in seizure frequency with Zebinix. Rights to commercialize the product in the U.S. and Canadian markets were licensed to Sepracor Inc., of Marlborough, Mass., in late 2007. (See BioWorld Today, Jan. 3, 2008.)

* Biolex Therapeutics Inc., of Pittsboro, N.C., said it completed patient enrollment in its SELECT-2 Phase IIb study of Locteron, a controlled-release formulation of interferon-alpha for the treatment of chronic hepatitis C. The Phase IIb study involves more than 100 treatment-naive, genotype-1, chronic hepatitis C patients. Biolex licensed rights to Locteron in October 2008 from OctoPlus NV, of Leiden, the Netherlands. (See BioWorld Today, Oct. 7, 2008.)

* CytRx Corp., of Los Angeles, said updated data from its Phase II STAR-1 registration trial of orally administered tamibarotene as a third-line treatment in acute promyelocytic leukemia showed that a durable complete response (the primary endpoint) was achieved when no leukemia cells can be found in the bone marrow (morphologic leukemia-free state or MLFS) for 28 days, the patient's neutrophil and platelet counts are increased to a certain level, and there is no sign of disease outside of the blood and bone marrow. Of the 11 patients enrolled in the STAR-1 trial to date, two patients have achieved durable complete response and one has achieved MLFS but withdrew from the trial to receive a bone marrow transplant before the durable complete response could be confirmed. One patient achieved a complete response but did not maintain MLFS for the required 28 days to be considered a durable complete response. Another patient achieved a durable MLFS but did not have the necessary increases in blood cells to be considered a durable complete response.

* DOR BioPharma Inc., of Princeton, N.J., said investigators at the Fred Hutchinson Cancer Research Center in Seattle published a paper in Bone Marrow Transplantationin which they demonstrated that DOR's lead product orBec (oral beclomethasone dipropionate) decreased noninfectious inflammation of the lung in acute gastrointestinal graft-vs.-host disease. Noninfectious inflammation of the lung is a common and potentially fatal complication of HCTs that decreases the exchange of oxygen and carbon dioxide between the lung and blood and, in its severe form, may present as interstitial pneumonitis.

* MorphoSys AG, of Martinsried, Germany, will receive a milestone payment from Centocor Ortho Biotech Inc., of Horsham, Pa., in connection with the start of a Phase I trial using a HuCAL-derived, fully human antibody in inflammation. The current program becomes the second HuCAL antibody derived from MorphoSys' collaboration with Centocor to enter the clinic. In 2007, Centocor started a Phase I study with a HuCAL antibody in oncology patients and commenced a Phase II trial in an immunological indication using the same antibody one year later. (See BioWorld Today, Jan. 4, 2001.)

* Vantia Therapeutics Inc., of Southampton, UK, disclosed positive results from a Phase IIa trial of its lead development compound, VA106483, for nocturia (waking frequently to urinate). The trial showed that oral VA106483 was successful in producing a predictable and sustained antidiuretic effect in patients, as determined by increased osmolality and decreased urine output. VA106483 was generally well tolerated.

* Yaupon Therapeutics Inc., of Radnor, Pa., completed enrollment for a pivotal Phase II trial of Clearazide in early stage cutaneous T-cell lymphoma. The study, which is being conducted under a special protocol assessment with the FDA, has enrolled 260 patients in 13 cancer centers in the US. Yaupon expects the last patient to complete treatment in the study by June 2010 and, assuming positive results, will file a new drug application shortly thereafter.

<>

Back to top

Return to Epilepsy News