FIBROGEN ANNOUNCES DATA ON CTGF ANTIBODY IN MICROALBUMINURIA
FibroGen has announced results of a Phase Ib study of FG-3019, a fully human monoclonal antibody against connective tissue growth factor (CTGF), in people with Type 1 or 2 diabetes and microalbuminuria, the earliest clinical sign of diabetic nephropathy.
The primary objectives of this open-label, multiple-dose, sequential-group, dose-escalation, multicenter study were to characterize the safety, tolerability and pharmacokinetics of FG-3019. Results demonstrated that FG-3019 was well-tolerated. Only one serious adverse event was reported, which was considered unrelated to the study drug. No dose-limiting toxicities were observed. Clearance of FG-3019 was saturable, and accumulation of FG-3019 in the bloodstream was limited during the dosing interval.
AEterna Zentaris Reports Positive Top Line Phase 1 Results for AN-152 in Patients with Gynaecological and Breast Cancers
AEterna Zentaris Inc. disclosed additional positive top line Phase 1 results for its cytotoxic conjugate AN-152 in patients with gynaecological and breast cancers. Further data showed the compound's good safety profile and established the maximum tolerated dose (MTD) at 267 mg/m(2) which will be the recommended dose for a Phase 2 trial. In addition to good safety data, the trial provided a hint of efficacy as disease stabilization and regression of lesions were observed at the 160 mg/m(2) and 267 mg/m(2) dose levels.
PEREGRINE BEGINS COMBINATION THERAPY CANCER TRIAL
Peregrine Pharmaceuticals has initiated a Phase Ib clinical trial to evaluate its lead anti-phospholipid immunotherapy agent bavituximab given in combination with common cancer chemotherapy agents. The trial is expected to enroll up to 12 patients at three clinical sites in India.
The trial is designed to test the safety and tolerability of bavituximab over an eight-week administration period when given with standard chemotherapy regimens including docetaxel, gemcitabine and carboplatin/paclitaxel. These regimens are commonly used for treating major cancer types, including breast, lung and pancreatic cancer. Study endpoints include safety and drug pharmacokinetics. Patients will also be evaluated for tumor response according to Response Evaluation Criteria in Solid Tumors criteria, although this assessment is not a formal endpoint of the study. Patients will be followed for an additional four weeks after their last dose of bavituximab and may continue with chemotherapy according to standard-of-care guidelines.
NEOPHARM PRESENTS SAFETY DATA ON MALIGNANT GLIOMA TREATMENT
Neopharm has announced the presentation of final Phase I safety results at the Society for Neuro-Oncology's annual meeting. Data from this 22-patient trial showed that 0.5 micrograms/mL of Cintredekin Besudotox delivered via convection-enhanced delivery followed by external beam radiation therapy (EBRT), with or without concurrent temozolomide, following tumor resection appears to be safe in patients with newly diagnosed malignant glioma.
Kamada Begins Phase I Clinical Trials of Its Aerosolized API Treatment for Congenital Emphysema
Kamada announced that it has begun human Phase I trials of an inhaled formulation of its flagship drug, Alpha 1-Proteinase Inhibitor (API). The trials will examine the product's safety on approximately 20 participants and will continue for several months according to a plan approved by the EMEA, the European Agency for Evaluation of Medicinal Products.
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