Date: 2015-08-31
Type of information: Completion of patient enrollment
phase: 1-2
Announcement: completion of patient enrollment
Company: Atara Biotherapeutics (USA - CA)
Product: PINTA 745
Action
mechanism: peptibody. PINTA 745 is a peptibody that binds myostatin and inhibits its corresponding signal transduction, thereby blocking the negative regulation of skeletal muscle growth. Through its biologic activity in blocking myostatin activity and in mitigating inflammatory mediators, PINTA 745 may have the potential to decrease the manifestations of protein-energy wasting, reduce the rates of serious complications, and improve functional status.
Disease: patients with end stage renal disease who require maintenance hemodialysis and have protein energy wasting
Therapeutic area: Kidney diseases - Renal diseases
Country: USA
Trial
details: This pilot study will assess the safety, pharmacokinetics and effectiveness of PINTA 745 or placebo in treating protein energy wasting (PEW) in patients receiving maintenance hemodialysis (MHD). (NCT01958970)
Latest
news: * On August 31, 2015, Atara Biotherapeutics, a biopharmaceutical company with a focus on developing innovative therapies for patients with debilitating diseases, announced that it completed enrollment in its blinded, randomized, PINTA 745 Phase 2 clinical trial in End-Stage Renal Disease (ESRD) patients with Protein Energy Wasting (PEW). The company expects to report preliminary top-line data by the end of the fourth quarter of 2015. Atara Bio is conducting a Phase 2 trial in patients with ESRD who are also suffering from PEW at six US-based sites. PEW refers to a state of muscle wasting, inflammation and malnutrition that increases patients' risk for infections, cardiovascular disease and other complications. The company believes that patients with PEW may benefit from the muscle-building demonstrated in earlier clinical trials and anti-inflammatory properties of PINTA 745 demonstrated in preclinical studies. The clinical trial was designed to provide proof of concept data for ESRD patients.
