CytRx Corp., of Los Angeles, reported that it's reached an agreement with the FDA for a special protocol assessment for a global Phase III trial with aldoxorubicin as a second-line treatment for patients with soft tissue sarcomas

The study is being conducted in two parts – a single-arm study expected to enroll 240 patients, with a primary endpoint of change in serum potassium from baseline to week four, and a withdrawal phase for subjects who responded to treatment in the first part of the trial – and is being conducted under a special protocol assessment with the FDA

The Echelon-2 trial is being conducted under a special protocol assessment (SPA) agreement from the FDA and also received scientific advice from the European Medicines Agency

Dipexium Pharmaceuticals LLC, of New York, said it reached an agreement with the FDA on a special protocol assessment for an upcoming Phase III study testing Locilex (pexiganan acetate cream 1 percent), an antibiotic peptide formulated as a topical cream, in mild infections of diabetic foot ulcers...Relypsa Inc., of Redwood City, Calif., said it reached agreement on a special protocol assessment with the FDA for a pivotal Phase III study testing patiromer in hyperkalemia (high serum potassium

Aeterna Zentaris Inc., of Quebec City, agreed with the FDA on a special protocol assessment for its Phase III registration trial of AEZS-108 in endometrial cancer

The trial is being carried out under special protocol assessment

The company recently met with the FDA to discuss a potential Phase III pivotal trial with aldoxorubicin for patients with soft-tissue sarcomas whose tumors have progressed following treatment with chemotherapy and plans to submit a special protocol assessment for the trial

SYNERGY, designed through a special protocol assessment with the FDA, is the first of two ongoing, pivotal Phase III studies evaluating potential survival benefit for custirsen in prostate cancer

The trial is being conducted under a special protocol assessment agreement from the FDA, and the trial also received scientific advice from the European Medicines Agency

ArQule Inc., of Woburn, Mass., said it reached a special protocol assessment agreement with the FDA for a pivotal Phase III trial of tivantinib in patients with hepatocellular carcinoma (HCC...Threshold Pharmaceuticals Inc., of South San Francisco, said the FDA reached agreement with partner Merck KGgA, of Darmstadt, Germany, for a special protocol assessment for a Phase III trial of TH-302 in patients with metastatic or locally advanced unresectable pancreatic cancer

The ADAPT study, which is being conducted under a special protocol assessment, is testing AGS-003 in combination with well-established targeted drug therapies and is expected to enroll about 450 newly diagnosed patients with metastatic disease

In conjunction with a special protocol assessment from the FDA, Depomed used a nonparametric analysis for the efficacy data from BREEZE 3 and performed a supportive parametric ANCOVA statistical analysis

The development program, which will address the drug in patients with risk factors or diagnoses for cardiovascular disease and those who have not had adequate efficacy from triptans, will be confirmed under a special protocol assessment process

It intends to apply for an FDA special protocol assessment agreement prior to initiating those

Teva Pharmaceutical Industries Ltd., of Jerusalem, and Active Biotech AB, of Lund, Sweden, plan to initiate a third Phase III study of oral laquinimod in relapsing-remitting multiple sclerosis following agreement with the FDA on the drug's special protocol assessment

Argos Therapeutics Inc., of Durham, N.C., said it secured a special protocol assessment for a Phase III study of AGS-003 in metastatic renal cell carcinoma

The 506-patient study is being conducted under a special protocol assessment from the FDA

The company intends to apply for FDA special protocol assessment prior to initiating the trials

The double-blind, placebo-controlled study, being conducted under an FDA special protocol assessment, is designed to enroll more than 1,000 patients with resected Stage IIb, IIc or III melanoma in Europe and the U.S. The biotech expects to reach the recurrence-free survival endpoint by mid-2016 and file an early biologic license application