Results from preliminary phase 1 clinical trial of CG0070 recorded anti tumour activities and less severe adverse effects, reports Cell Genesys, Inc.
The company studied the results of the new drug candidates in patients with recurrent bladder cancer who have failed previous therapy with bacillus Calmette-Guerin (BCG), the current standard therapy for recurrent bladder cancer.
Nine patients have been treated to date who received escalating single-dose administrations of CG0070. Evidence of anti-tumour activity documented by a complete response at follow-up cystoscopy was obtained in three of the nine patients treated. Treatment was tolerable with no serious adverse events or dose limiting toxicities reported to date.
CG0070, an oncolytic virus therapy, has been shown to destroy cancer cells of multiple types in numerous preclinical studies. CG0070 is the first "armed" oncolytic virus therapy developed by the company, so-named because it has been engineered to include the therapeutic gene for GM-CSF, an immune stimulating hormone which is also a key component in Cell Genesys' lead product platform, GVAX cancer immunotherapies. As a result, CG0070 can potentially destroy cancer cells by two different mechanisms: direct cell killing by the virus and immune-mediated cell killing stimulated by GM-CSF.
"We are pleased with the early results for CG0070, our lead oncolytic virus therapy product in clinical trials and believe that this study strongly supports advancement of CG0070 into a multiple-dose phase 1 trial," stated Joseph J. Vallner, president and chief operating officer of Cell Genesys. "We are optimistic that the dual mechanism of action of CG0070 might result in enhanced local anti-tumour activity as well as potential systemic anti-tumour immunity following local administration," he added.
Oncolytic (cancer cell killing) virus therapies represent a new approach in the treatment of patients with cancer and are comprised of adenoviruses, a cause of the common cold, that are engineered to selectively replicate in and destroy cancer cells through the use of tumour- or tissue-specific promoters. Cell Genesys is developing certain of its oncolytic virus therapy products through a global alliance with Novartis AG, which may provide for the further development and commercialization of these products. Additionally, the alliance provided Cell Genesys with preclinical stage product opportunities developed by Novartis, including CG0070. In addition to CG0070, Cell Genesys is also developing CG5757, which is engineered with a secondary telomerase promoter employing technology licensed from Geron Corporation, and may also have the potential to target multiple types of cancer.