IRVINE, Calif.--(Cold Genesys, Inc. (“CGI”, the company) announced today that the Company has reached agreement with the U.S. Food and Drug Administration (FDA) under its Special Protocol Assessment (SPA) process for the Company’s proposed Phase 2/3 pivotal BOND (Bladder Oncolytic virus for Non-muscle invasive bladder cancer Disease) Trial of intravesical (bladder instillation) CG0070 for non-muscle invasive bladder cancer patients with carcinoma-in-situ (“Cis”) or Cis with Ta and/or T1 who have previously failed BCG (Bacillus Calmette-Guerin, a standard intravesical treatment) and refused cystectomy. The SPA provides FDA agreement that the study design and planned statistical analysis of this Phase 2/3 pivotal trial adequately address objectives necessary to support a regulatory submission, provided other conditions, such as chemistry, manufacturing and controls of new CG0070 materials can be adequately tested in the phase 3 portion, and success in a well conducted and internally consistent clinical trial that can reach a convincing statistical conclusion are satisfied.)--
“We are pleased to have reached this agreement with the FDA. The only alternative for these patients is radical cystectomy, which carries an unacceptably high percentage of life long morbidities and a small but significant chance of mortality. Furthermore, the frequent and prolonged need for costly medical care and unavoidable personal hygienic problems post-cystectomy will certainly and severely affect the self-esteem of this elderly population. Practically no patient wants a cystectomy.” said Dr. Alex Yeung, President of Cold Genesys. “Key issue in this SPA is the chance, if successful, of confirming the special positioning of CG0070 in non-muscle invasive bladder cancer. We will be searching for the right partners for clinical and manufacturing as soon as possible to ensure that the Phase 3 portion of our trial will not be delayed.”
About Special Protocol Assessments
A Special Protocol Assessment is a binding declaration between a sponsor and the FDA indicating that a proposed Phase 3 or Phase 2/3 study design, endpoints, and statistical analyses are acceptable to a Biologics License Application (BLA). Final marketing approval in the U.S. will depend on study results, safety issues and an overall evaluation. More information on Special Protocol Assessments can be viewed at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080571.pdf
CG0070 in Bladder Cancer
CG0070 was previously tested in a Phase 1/2 trial of 35 patients with non-muscle invasive bladder cancer in 2008. Good response rate and durable response, especially those associated with Cis, were noted.
ASCO GU meeting (Feb 2-4, 2012) abstract #271 and ASCO annual meeting 2012 (June 1-5, 2012) abstract #4593.
About Cold Genesys
Cold Genesys Incorporated is a privately held biopharmaceutical company that is focused on delivering innovative conditionally replicative (Rb pathway defective molecule E2F as the viral E1A gene promoter) competent oncolytic adenovirus vector expressing GM-CSF for the treatment of patients with bladder cancer. CGI acquired the intellectual property rights related to CG0070 previously held by Cell Genesys, Inc. and BioSante Pharmaceuticals in a transfer and royalty agreement on November 15, 2010. Cold Genesys was launched in August 2010. The company's shareholders include BioSante Pharmaceuticals (Nasdaq: BPAX).
For Safe Harbor and Other Information
Visit our website at www.coldgenesys.net