Date: 2015-02-09
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Cold Genesys (USA - CA)
Product: CG0070
Action
mechanism: oncolytic virus/immunotherapy product. CG0070 is an investigational oncolytic immunotherapy based on a modified common cold adenovirus backbone that contains a cancer-specific promoter and a GM-CSF transgene. CG0070 was designed to work in two important and complementary ways. First, it replicates inside the tumor’s cells causing tumor cell lysis and immunogenic cell death. Then, the rupture of the cancer cells can release tumor-derived antigens, along with GM-CSF, that can stimulate a systemic anti-tumor immune response that involves the body’s own white blood cells.
Disease: high grade non-muscle invasive bladder cancer (NMIBC) after failure of BCG therapy
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: The BOND2 study is an open lavel, single arm, phase 3, multicenter study that examines the safety and efficacy of CG0070, an oncolytic virus expression GMCSF in high grade non muscle invasive bladder cancer patients who failed BCG therapy and refused cystectomy. The plan is to study the safety and efficacy of CG0070 in high-grade NMIBC patients who failed BCG therapy. Most patients with NMIBCis (Cis, Cis with Ta and/or T1, high grade Ta or T1 with frequent or uncontrolled recurrences) who have failed BCG intravesical therapy (standard of care) usually have no other choice but to proceed to cystectomy. Cystectomy is a surgery associated with major morbidity, mortality and quality of life issues. Morbidity and long term tedious medical care will be for the rest of the patient's life span. Most patients at this stage do not show signs of disease progression into the muscle layer or of metastasis, making surgery a very difficult decision. CG0070, if successful in this trial, will serve to provide a therapeutic alternative for this patient population in need. (NCT02365818)
Latest
news: * On February 9, 2015, a Phase 3 trial sponsored by Cold Genesys was published on the NIH website ClinicalTrials.gov for CG0070 and is currently recruiting participants.
