NEW YORK - Protara Therapeutics, Inc. (NASDAQ:TARA), a clinical-stage company focusing on cancer and rare diseases, announced positive three-month data from its ongoing clinical program for TARA-002, an investigational cell-based therapy for Non-Muscle Invasive Bladder Cancer (NMIBC). The study includes patients unresponsive or inexperienced with Bacillus Calmette-Guérin (BCG) treatment.
The three-month results showed a complete response rate of 43% in BCG-Unresponsive/Experienced patients and 63% in CIS-only patients. The safety profile was favorable, with no Grade 3 or higher treatment-related adverse events reported.
The ADVANCED-1 and ADVANCED-2 clinical trials are evaluating TARA-002 in various NMIBC patient populations. Preliminary data from these studies suggest potential for increased complete response rates following reinduction, a process that has shown a 30%-50% salvage rate with other immune agents in NMIBC patients with CIS.
The ADVANCED-2 trial, which is ongoing, will provide further data from six-month evaluable patients in the second half of 2024. This trial includes reinduction and maintenance dosing and is designed to align with the FDA’s guidance for BCG-Unresponsive NMIBC treatment.
The reported adverse events were mostly Grade 1 and 2, typical for bacterial immunopotentiators, with symptoms such as fatigue, headache, fever, and urinary discomfort.
TARA-002, developed from the same master cell bank as OK-432 (Picibanil®), used in Japan and Taiwan, is administered similarly to BCG, making it suitable for use in community urology practices.
Protara Therapeutics is continuing enrollment and study in the NMIBC program, exploring additional dosing cohorts and a combination study with pembrolizumab. The company’s focus remains on advancing therapies for unmet medical needs, including NMIBC and lymphatic malformations.
This announcement is based on a press release statement from Protara Therapeutics.
InvestingPro Insights
As Protara Therapeutics (NASDAQ:TARA) showcases promising clinical data for its TARA-002 therapy, investors are closely monitoring the company's financial health and market performance. The latest metrics from InvestingPro reveal a market capitalization of $45.96 million, reflecting the company's current valuation in the market. Despite the challenges often faced by clinical-stage companies, Protara holds a notable cash position relative to its debt, which is an encouraging sign for stakeholders considering the company's future funding needs.
InvestingPro Tips highlight that Protara is experiencing rapid cash burn and is not expected to be profitable within the current year. In addition, the company's stock price has been characterized by high volatility. However, it's worth noting that Protara's liquid assets surpass its short-term obligations, providing a cushion for near-term operational expenses. With a significant 139.29% price uptick over the last six months and a 114.39% year-to-date price total return, the stock has demonstrated strong short-term performance, which may interest traders looking for momentum plays.
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