Business
Protara Therapeutics Announces Fourth Quarter and Full Year 2020 Financial Results and Business Overview
- Initiation of Phase 1 Trial of TARA-002 in Patients with Non-Muscle Invasive Bladder Cancer on Track to Commence by Year-End - - In Discussions with FDA on
About this update from Protara Therapeutics, Inc.
[{"type":"text","content":"- Initiation of Phase 1 Trial of TARA-002 in Patients with Non-Muscle Invasive Bladder Cancer on Track to Commence by Year-End - - In Discussions with FDA on Next Steps Needed to File BLA for TARA-002 in Lymphatic Malformations - - On Track to Complete GMP Scale up and Comparability in 2H, 2021 - - Strong Cash Position of $169M as of December 31, 2020 - NEW YORK, March 11, 2021 (GLOBE NEWSWIRE) -- Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases with significant unmet needs, today announced financial results for the fourth quarter and year ended December 31, 2020 and provided a business update. “We believe 2021 will be a transformative year for Protara, and we are entering it with strong momentum,” said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. “We remain on track to commence a Phase 1 study of TARA-002 in patients with non-muscle invasive bladder cancer (NMIBC), a pressing area of unmet need, by the end of the year. We believe that TARA-002 has the opportunity to play a meaningful role in the current NMIBC treatment landscape.” Mr. Shefferman continued, “We are in discussions with the U.S. Food and Drug Administration’s (FDA) Division of Vaccines and Related Products to establish a path forward to file our Biological License Application (BLA) for TARA-002 in lymphatic malformations (LMs). We are encouraged by the progress to date and, at the FDA’s request, have submitted the full Clinical Study Report (CSR) of a randomized Phase 2 study of OK-432 (the originator compound of TARA-002) in LMs led by the University of Iowa. We look forward to continuing our dialogue with the FDA.” Recent Highlights and Upcoming Milestones TARA-002 in NMIBC Protara remains on track to complete select non-clinical studies to characterize local toxicity of intravesical administration of TARA-002 in the first half of 2021, with an Investigational New Drug (IND) application submission anticipated in the second half of 2021. Subject to FDA acceptance of the IND application, the Company plans to commence a Phase 1 study by the end of 2021 to assess the safety and tolerability of TARA-002 in patients with NMIBC, including patients with carcinoma in situ (CIS). TARA-002 in LMs Protara plans to utilize the robust dataset for OK-432 (...