In This Article:
- First Patient Dosed in Expanded Access Program and Enrollment Ongoing -
IRVINE, Calif., June 18, 2024 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients with bladder cancer, today announced that it has initiated an Expanded Access Program (EAP) for cretostimogene grenadenorepvec in the U.S. for patients with Non-Muscle Invasive Bladder Cancer (NMIBC) who are unresponsive to Bacillus Calmette-Guerin (BCG) and meet certain program eligibility criteria. The first patient has been dosed in the EAP and enrollment in the study is ongoing.
“Bladder cancer is a highly recurrent disease with few treatment options available to patients,” said Ambaw Bellete, President & Chief Operating Officer, CG Oncology. “This program reflects our commitment to patients afflicted with NMIBC and our desire to ensure that they have efficient access to cretostimogene, our novel oncolytic immunotherapy candidate.”
"Navigating NMIBC can be a journey filled with uncertainties, especially given how frequently bladder cancer recurs," said Andrea Maddox-Smith, CEO of the Bladder Cancer Advocacy Network (BCAN). "At BCAN, patients are at the forefront of everything we do. Despite the progress being made to find new treatments, there are times when patients have exhausted all approved treatment options, and they are not eligible for a traditional clinical trial. Expanded Access Programs represent tremendous hope for these patients and their families, by allowing them access to investigational drugs that they would not otherwise have available to them."
About Expanded Access to Cretostimogene Grenadenorepvec
EAP programs are intended to serve as a potential pathway for a patient with a serious or immediately life-threatening disease or condition, to gain access to an investigational medical treatment outside of clinical trials before it is approved by the U.S. Food and Drug Administration (FDA), when no comparable or satisfactory alternative therapy options are available. Healthcare providers and bladder cancer patients who are interested to learn more about CG Oncology’s EAP including eligibility criteria may visit www.clinicaltrials.gov, NCT06443944, or contact EAP@cgoncology.com.
To learn more about CG Oncology’s clinical studies please visit the CG Oncology website at www.cgoncology.com.
About Cretostimogene Grenadenorepvec
Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy being evaluated in BOND-003, a Phase 3 clinical trial for the treatment of patients with high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) who are unresponsive to Bacillus Calmette-Guerin (BCG) therapy. Cretostimogene is also being evaluated in a Phase 3 monotherapy clinical trial (PIVOT-006) in intermediate-risk NMIBC patients. In addition, cretostimogene is being evaluated in an investigator-sponsored clinical trial in combination with nivolumab for the treatment of muscle invasive bladder cancer.