Engene Holdings Inc. ((ENGN)) announced an update on their ongoing clinical study.
Elevate Your Investing Strategy:
- Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence.
Study Overview: The LEGEND Study, officially titled A Phase 1/2 Study of EG-70 as an Intravesical Administration to Patients With BCG Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) and High-Risk NMIBC Patients Who Are BCG Naïve or Received Incomplete BCG Treatment, aims to evaluate the safety and efficacy of EG-70. This study is significant as it targets patients with NMIBC who are unresponsive to BCG therapy or have not been fully treated, potentially offering a new therapeutic option.
Intervention/Treatment: The intervention being tested is EG-70, a drug administered intravesically. It is designed to treat bladder tumors in NMIBC patients, with a focus on those who are BCG-unresponsive or have not received complete BCG treatment.
Study Design: The study is interventional, with a non-randomized, sequential model. It involves two phases: Phase 1 focuses on dose escalation to establish safety, while Phase 2 assesses the treatment’s efficacy. There is no masking, and the primary purpose is treatment.
Study Timeline: The study began on February 4, 2021, and is currently recruiting. The last update was submitted on September 2, 2025. These dates are crucial for tracking the study’s progress and potential impact on treatment options.
Market Implications: This study update could positively influence Engene Holdings Inc.’s stock performance, as successful results may enhance investor confidence and position the company as a leader in NMIBC treatment. Competitors in the bladder cancer treatment market may need to adjust strategies in response to these developments.
The study is ongoing, with further details available on the ClinicalTrials portal.