• Allos Therapeutics Inc., of Westminster, Colo., said an independent data monitoring committee completed the pre-specified 65-patient safety review of data from the firm's pivotal Phase II trial of PDX (pralatrexate) in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) and recommended that the trial continue per the protocol. The interim assessment was based on an evaluation of patients enrolled in the study who completed at least one cycle of treatment with PDX. The company expects to complete patient enrollment in the second quarter of 2008. The PROPEL (Pralatrexate in Patients with Relapsed or Refractory Peripheral T-cell Lymphoma) study is an open-label, single-arm trial that plans to enroll at least 100 evaluable patients with relapsed or refractory PTCL who have progressed after at least one prior treatment. The primary endpoint of the study is objective response rate, or complete and partial response. Secondary endpoints include duration of response, progression-free survival and overall survival. The PROPEL trial is being conducted under the FDA's special protocol assessment process. Regulators in 2006 granted orphan drug designation and fast-track status to PDX for the treatment of T-cell lymphoma.

• Northwest Biotherapeutics Inc., of Bethesda, Md., said the first patients have been enrolled and have undergone initial treatment steps in a Phase I/II trial of DCVax-L for recurrent ovarian cancer. DCVax-L is a personalized immunotherapy for cancer that is made from a patient's own dendritic cells and antigens from the patient's own tumor tissue, which has been surgically removed as part of the standard of care. Patients in the study first will undergo standard surgery to reduce their tumor burden and then receive limited doses of two existing drugs to improve the immune system environment and modify the tumor vasculature. Following the preparatory treatments, the patients will receive a series of three immunizations with DCVax-L, each two weeks apart, while continuing to receive the low doses of two drugs intended to keep the immune system and the tumor microenvironment in a beneficial condition. A second study will compare two treatment arms, continuing further with the drug-plus-DCVax-L regimen, and adding the adoptive transfer of DCVax-L primed and expanded T cells.

• Prosensa BV, of Leiden, the Netherlands, and Leiden University Medical Center published results of a Phase I trial with PRO051 in Duchenne's muscular dystrophy. PRO051, a systemic RNA-based therapeutic, restored dystrophin expression in the treated muscle fibers of all four patients tested. The data were published in the New England Journal of Medicine. Prosensa is planning a Phase I/II trial.

• VGX Pharmaceuticals Inc., of Blue Bell, Pa., said it successfully completed its first study to assess the tolerability of its vaccine delivery device, Cellectra, in 10 healthy adults. On average, the patients reported a moderate level of short-lived discomfort during the procedure. Other complaints were mild and did not require any treatment, the firm said. Currently, VGX is testing the first of its DNA vaccine candidates, Pennvax-B, in Phase I trials as a preventative vaccine for HIV infection. The firm also plans to file investigational new drug applications for three additional products in the first half of 2008: VGX-3100, a therapeutic vaccine for the treatment for cervical cancer; VGX-3200, a therapeutic based on human growth hormone-releasing hormone for cancer-related cachexia; and VGX-3400, a pandemic avian flu vaccine. All four vaccines are delivered by the Cellectra device.

No Comments