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Protara Therapeutics Announces Dosing of First Patient in Phase 2 STARBORN-1 Trial of TARA-002 in Pediatric Patients with Lymphatic Malformations
NEW YORK, Oct. 23, 2023 (GLOBE NEWSWIRE) -- Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the
About this update from Protara Therapeutics, Inc.
[{"type":"text","content":"NEW YORK, Oct. 23, 2023 (GLOBE NEWSWIRE) -- Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, today announced that dosing is now underway in the Phase 2 STARBORN-1 trial evaluating TARA-002, an investigational cell-based immunopotentiator, for the treatment of pediatric patients with lymphatic malformations (LMs). “There is a pressing need for an effective FDA-approved therapy to treat LMs, a rare condition mainly affecting children. There are currently no such agents that are FDA approved specifically for this indication,” said Nancy Bauman, MD, Children's National Medical Center: Children's Research Institute, Washington DC, and investigator for the STARBORN-1 trial. “Having witnessed first-hand in prior studies the significant benefit observed with OK-432, the predecessor of TARA-002, I firmly believe that TARA-002 has the potential to play a meaningful role in this vulnerable patient population.” STARBORN-1 is a Phase 2 single-arm, open-label, prospective clinical trial to evaluate the safety and efficacy of intracystic injection of TARA-002 for the treatment of macrocystic and mixed cystic LMs (≥ 50% macrocystic disease) in participants six months to less than 18 years of age. Including an age de-escalation safety lead-in, the trial will enroll approximately 30 patients who will receive up to four injections of TARA-002 spaced approximately six weeks apart. “Initiation of the STARBORN-1 trial marks an important step forward for our LMs program and, more importantly, the young patients impacted by this rare condition,” said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. “We are committed to bringing TARA-002 to patients suffering from this devastating disease and look forward to advancing this study.” The primary endpoint of the trial is the proportion of participants with macrocystic and mixed cystic LMs who demonstrate clinical success, defined as having either a complete response (90% to 100% reduction from baseline in total LM volume) or substantial response (60% to less than 90% reduction in total LM volume) as measured by axial imaging. TARA-002 is an investigational cell therapy based on the broad immunopotentiator, OK-432, which was originally granted marketing approval by the Japanese Ministry of ...