Protara Therapeutics Inc. (TARA:NASDAQ), at the American Urological Association's recent annual meeting, presented "tantalizing" initial 12-month efficacy results from the ongoing Phase 2 trial of its TARA-002 cell therapy in high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ, with or without papillary tumors, reported Oppenheimer Analyst Dr. Leland Gershell in an April 27 research note.
Oppenheimer's rating on Protara is Outperform.
Complete Response Data
In the poster session at the AUA meeting, Protara shared the complete response rates seen among both categories of patient in the trial, reported Gershell.
Among the patients with Bacillus Calmette-Guérin (BCG)-unresponsive disease, 67% (two of three evaluable patients) had a complete response. The complete response rate at any time was 100% among five patients.
Within the group of patients with BCG-naïve disease, the complete response rate was 43% (in three of seven evaluable patients). The complete response rate at any time was 76% (in 16 out of 21 patients).
Also of note, according to Gershell, TARA-002 was shown to be safe. There were no Grade 3+ related adverse events or dropouts due to safety.
"Key opinion leader input we received at the conference that considered the reveal along with TARA-002's low-burden handling/administration increases our enthusiasm for this candidate's prospects within the evolving NMIBC therapeutic landscape," Gershell wrote.
What to Watch For
Looking forward, it is the BCG-unresponsive group that will drive registration with the U.S. Food and Drug Administration, noted the analyst. Accordingly, Protara expects to report six-month data on about 25 patients in this cohort by year-end.
"We are optimistic that this larger and more mature data set will further solidify the case for TARA-002," Gershell added.
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