Cold Genesys, Inc. is committed to the development of an innovative cancer immunotherapy.  This approach prompts the body’s immune system to sample and select the best way to detect and eventually eliminate rogue cancer cells, wherever they may be.  In many ways, this mechanism is very similar to the 80 or more forms of autoimmune diseases found in humans. Common diseases such as rheumatoid arthritis, systemic lupus erythematosus, myasthenia gravis, diabetes (type 1), multiple sclerosis, etc., are all diseases where the body’s own immune system attacks and destroys a large number of normal cells. Cold Genesys technology is based on a similar ability to harness the complex autoimmune system and cascade like actions of different cytokines, chemokines, antigen presenting cells, T cells and B cells, in order to direct this effort to attack the patients cancer cells.  

The company's first product is a proprietary oncolytic virus, CG0070(adenovirus) and is currently being developed for patients suffering from BCG resistant superficial bladder cancer. CG0070 is a viral vector designed to multiply specifically in cancer cells, resulting in targeted cancer cell death. A second important aspect of this virus is its capacity to express a powerful immune stimulating signal called GM-CSF. This cellular signaling molecule stimulates and attracts natural immune cells such as dendritic cells and T cells to the targeted cancer site. Cold Genesys' viral therapy promotes specific immunity against certain cancers by equipping natural immune cells with specific cancer antigens. This dual mechanism, of oncolytic effects and GM-CSF expression, enables the body's natural immune system to search out and eradicate residual cancer cells through out the body.

Our initial focus will be to initiate a Phase II/III Protocol in patients with Non-Muscle Invasive Bladder Cancer  who are resistant to BCG and recommended or have refused cystectomy. In addition, an exploratory Phase II Protocol for patients awaiting surgical removal of the bladder due to muscle invasive disease is also actively being developed. The long-term development plan is to seek a Phase III trial in either or both of the above indications in the latter part of 2013.

Disclaimer: 

CG0070 refers to an investigational product being developed for the treatment of bladder cancer.  The efficacy and safety of this product is under active investigation, and has not received regulatory approval from the US FDA or any other regulatory authority.  This immunotherapy product is restricted to investigational use only.

What We Do

we are seeking a phase II continuing to a Phase III trial to study the effect of our leading product, CG0070 in bladder cancer.

To learn about how you can enroll as a patient in this trial, please check this website after June, 2012.