- The stock price of Protara Therapeutics Inc (NASDAQ: TARA) increased by over 9% during intraday trading today. This is why it happened.
The stock price of Protara Therapeutics Inc (NASDAQ: TARA) – a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases – increased by over 9% during intraday trading today. Investors are responding positively to Protara Therapeutics announcing the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for TARA-002, an investigational cell-based therapy being developed for the treatment of non-muscle invasive bladder cancer (NMIBC). And Protara expects to initiate a Phase 1 clinical trial of TARA-002 in adults with high-grade NMIBC by the end of 2021.
The Phase 1 dose-finding, open-label trial will evaluate TARA-002 in treatment-naïve and treatment-experienced NMIBC patients with high-grade carcinoma in situ (CIS) and high-grade papillary tumors (Ta). And in the initial dose-escalation phase of the trial, patients will receive 6 weekly intravesical doses of TARA-002. The primary objective of the trial is to evaluate the safety, tolerability, and preliminary signs of anti-tumor activity of TARA-002 with the goal of establishing a maximum tolerated dose and recommended dose for a future Phase 2 clinical trial.
TARA-002 is manufactured from the same cell bank as OK-432 – an approved therapy in Japan and Taiwan for multiple oncologic indications. And last year, Protara successfully demonstrated initial manufacturing comparability between TARA-002 and OK-432. The confirmatory GMP-scale comparability data for TARA-002 in relation to OK-432 have been completed and were reviewed by FDA as part of the clearance of the IND.
“We are thrilled to have reached this important milestone and look forward to quickly initiating our Phase 1 study in patients with NMIBC. There is an urgent need for new treatments for NMIBC. We are seeing significant increases in recurrence and disease progression, as well as an escalating number of patients requiring cystectomies. Supported by the strength of the existing clinical data in NMIBC for OK-432, the originator therapy for TARA-002, we believe this treatment represents a promising new option for NMIBC patients.”
— Jesse Shefferman, Chief Executive Officer of Protara Therapeutics
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