BioVex Inc, a company developing new generation biologics for the treatment and prevention of cancer and infectious disease, announced today that the data from its completed Phase 2 clinical study of OncoVEX (GM-CSF) for the treatment of advanced melanoma has been published in the Journal of Clinical Oncology (JCO). The previously announced top line results report a high objective durable response rate and a high complete response rate, combined with a relatively benign side effect profile. Overall, 20% of patients ultimately achieved a complete response and 28% of patients achieved an overall objective response (complete response or partial response). Ninety two percent of the responses are durable as defined as lasting at least 6 months, and the majority are ongoing, with a range of 18 to 40 months. Responses were observed in patients with all stages of disease, including the complete resolution of visceral deposits. The study results were made available online today on the JCO website and will be published in the December 2009 print edition. The Phase 2 study was led by Dr. Neil N. Senzer of The Mary Crowley Cancer Research Center, Dallas, TX.
“The high percentage of durable complete responses in this study suggests that this therapy has the potential to provide long term benefit to responding patients, potentially including cures,” said Dr. Neil N. Senzer of The Mary Crowley Cancer Research Center, Dallas, TX. “OncoVEX (GM-CSF) offers significant promise in providing a real advance in the treatment of a disease where there are few if any effective treatment options, particularly when coupled with a relatively benign side effect profile.”
“In addition to use in more advanced patients, these encouraging results suggest OncoVEX (GM-CSF) has the potential to be used to intervene in the early stages of metastatic disease where it might act to reduce the high rate of progression to widespread disease and death,” said Dr. Howard Kaufman of the Rush University Medical Center in Chicago, principal investigator of an ongoing Phase 3 OPTiM(TM) study with OncoVEX (GM-CSF) in Stage III and Stage IV melanoma. “The ability to simply administer the vaccine in the office setting represents a significant improvement in quality of life for patients with melanoma.”
“We believe that OncoVEX (GM-CSF) is the most advanced clinical development program globally using viruses for cancer therapy, and we are committed to the further evaluation of OncoVEX (GM-CSF) for the treatment of metastatic melanoma and other solid tumors,” said Robert Coffin, PhD, Founder & Chief Technology Officer of BioVex.