CytRx Corp., of Los Angeles, said the independent data safety monitoring committee overseeing the company's international Phase IIb trial with aldoxorubicin as a first-line treatment for patients with late-stage metastatic soft tissue sarcoma has recommended conducting the clinical trial through completion

Catalyst Pharmaceutical Partners Inc., of Coral Gables, Fla., said the independent data monitoring committee recommended that the company continue as planned its pivotal Phase III study testing Firdapse for the treatment of Lambert-Easton myasthenic syndrome (LEMS), a rare autoimmune disorder characterized by muscle weakness of the limbs...The data monitoring committee agreed that the study should continue to completion, using the dose regimen of 150 mg three times daily for CNV1014802

The company also said an independent data monitoring committee reported a third positive analysis of safety data from the prostate cancer trial

Protalex Inc., of Summit, N.J., said that following a planned interim safety review by a data safety monitoring committee, it will continue enrollment and dosing of patients in its Phase Ib trial of PRTX-100 in combination with methotrexate and leflunomide for rheumatoid arthritis

Trophos SA, of Marseille, France, said it completed an interim analysis of the pivotal study of olesoxime in spinal muscular atrophy, a rare neurodegenerative condition, and the data monitoring committee recommended that the trial continue as planned

ProFibrix BV, of Leiden, the Netherlands, said the data monitoring committee (DMC) of its pivotal FINISH-3 trial of Fibrocaps in spine, liver, vascular and soft tissue surgery unanimously recommended the study continue as designed

CytRx Corp., of Los Angeles, said a data safety monitoring committee recommended continuing a Phase IIb trial of tamibarotene with chemotherapy in non-small-cell lung cancer

The agency's Division of Metabolism and Endocrinology Products proposed a resubmission procedure that allows the independent data monitoring committee's summary report of an interim analysis of the ongoing Light Study, the cardiovascular outcomes trial required by the FDA for approval of Contrave, to form the basis for the resubmitted NDA

PharmaMar SA, of Madrid, Spain, was notified by an independent data monitoring committee that it should complete its ongoing Phase III trial of Aplidin (Admyre) in relapsed/refractory multiple myeloma

Diffusion Pharmaceuticals LLC, of Charlottesville, Va., said it completed a Phase I trial of lead compound trans sodium crocetinate (TSC) in nine patients with newly diagnosed primary glioblastoma (GBM), and a safety monitoring committee authorized immediate open enrollment for a follow-on Phase II trial

Ziopharm Oncology Inc., of New York, said an independent data monitoring committee recommended that a Phase III trial of palifosfamide (ZIO-201) proceed as designed, with no changes

Nanobiotix, of Paris, said the independent data monitoring committee recommended continuing enrollment in the firm's Phase I study testing NBTXR3 in advanced soft-tissue sarcoma of the extremity

ProFibrix BV, of Leiden, the Netherlands, said it has enrolled more than half of the patients in its pivotal Phase III trial (FINISH-3) testing Fibrocaps, a mixture of blood-clotting proteins fibrinogen and thrombin formulated as a topical fibrin sealant, and also concluded a meeting of the data monitoring committee

Cel-Sci Corp., of Vienna, Va., said an interim review of safety data from its pivotal Phase III trial testing Multikine (leukocyte interleukin, injection) immunotherapy by an independent data monitoring committee raised no safety concerns

Nymox Pharmaceutical Corp., of Hasbrouck Heights, N.J., said the independent data monitoring committee for its Phase II study of NX-1207 for low-risk localized prostate cancer reported a second positive analysis of safety data

Nymox Pharmaceutical Corp., of Hasbrouck Heights, N.J., said the independent data monitoring committee for the Phase II study of NX-1207 in low-risk localized prostate cancer reported a positive interim analysis from the first group of patients to receive either a high- or low-dose of the drug

Nymox Pharmaceutical Corp., of Hasbrouck Heights, N.J., reported favorable results from the most recent safety monitoring committee review for the company's ongoing Phase III pivotal studies of NX-1207 in benign prostatic hyperplasia

ImmunoCellular expects the data safety monitoring committee to conduct an interim safety analysis when 32 events have occurred, which is anticipated in the first quarter of 2013...After at least 87 events have been adjudicated, the study's data monitoring committee will conduct an interim analysis and, pending positive results, Orexigen plans to resubmit a new drug application for Contrave

BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., said the independent data monitoring committee completed the ninth unblinded review of the LibiGel Phase III cardiovascular events and breast cancer safety study, recommending that the safety study should continue as per the FDA-agreed protocol, without modifications