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Protara Therapeutics Inc (NASDAQ: TARA) after the FDA gave clearance to their Investigational New Drug (IND) application for TARA-002, which is meant to treat non-muscle invasive bladder cancer (NMIBC).
The clinical-stage company said it plans to start a phase I study of TARA-002 in adults with high-grade NMIBC by the end of 2021.
The phase I study will focus on patients suffering from high-grade papillary tumours (Ta) and high-grade carcinoma in situ (CIS) who have previous treatment experience and those with treatment experience.
TARA-002 is manufactured from the same cell bank as OK-432, an approved therapy in Japan and Taiwan for multiple oncologic indications.
Protara confirmed the manufacturing comparability between OK-432 and TARA-002 in 2020 via GMP-scale comparability data, which the FDA reviewed before today’s clearance.
Jesse Shefferman, Protara Therapeutics CEO, said: “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.”
Investors cheered the news, as evidenced by the premarket rally in Protara stock.
Protara stock price.
Protara Therapeutics stock rallied 14.81% premarket to trade at $7.75, rising from Monday’s closing price of $6.75.
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