WOBURN, Mass., Nov. 2 /PRNewswire/ -- 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.
“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.”
About the Phase 2 OncoVEX (GM-CSF) Study in Melanoma
The Phase 2 trial enrolled 50 patients with Stage IIIc (10 patients) and Stage IV melanoma (40 patients) who were treated with OncoVEX (GM-CSF) as a stand-alone therapy. The trial was designed to measure overall objective response, which is defined as a complete response, where disease is completely eliminated, or partial response, where there is a more than 30% reduction in disease burden. The vast majority of patients who entered the study had progressive disease after having failed conventional and experimental prior therapies. Fourteen objective systemic responses (28% objective response rate) were ultimately achieved, including on an extension protocol to which four patients were transferred having completed the main study, including 10 complete responses. Responses have been maintained for up to nearly four years so far. Responses were observed in patients with all stages of disease, including the complete resolution of un-injected visceral deposits.
About Metastatic Melanoma
According to the American Cancer Society, more than 8,000 people died in the U.S. of melanoma in 2008. Prevalence of Stage III and Stage IV disease is 120,000 and median survival for Stage IV disease is six months.
About OncoVEX
The Company’s lead cancer treatment, OncoVEX (GM-CSF) is a first-in-class oncolytic, or cancer destroying virus, that works by replicating and spreading within solid tumors (leaving healthy cells unaffected), thereby causing cancer cell death and stimulating the immune system to destroy un-injected metastatic deposits. Both modes of action have been clearly validated in the clinic, where multiple patients with metastatic disease progressing at enrollment have been declared disease free. BioVex believes OncoVEX (GM-CSF) has the potential to become a leading standard of care in the treatment of many solid tumors based on the strength of clinical data so far generated coupled with the relatively benign side effect profile noted to date. Previous clinical trials have enrolled patients with breast cancer, melanoma, head and neck cancer and pancreatic cancer, with indications of clinical activity being observed in each. The Company recently commenced a Phase 3 study in metastatic melanoma following the achievement of an unprecedented proportion of durable complete remissions in a Phase 2 study using OncoVEX (GM-CSF) as a stand alone therapy. An overview of the Phase 2 melanoma results is available on the BioVex website. In September 2009 the Company received approval under the SPA procedure in relation to a second Phase 3 study in head and neck cancer.
In addition to OncoVEX, the Company has a second development program, ImmunoVEX (HSV2), a vaccine for genital herpes that provides complete protection in animal models of the disease. The vaccine has been authorized to commence clinical testing in the United Kingdom.
CONTACT: Mr Philip Astley-Sparke, President & CEO, BioVex Inc,
+1-781-376-4913, pastleysparke@biovex.com; or Mariesa Kemble (Media), Suda
Communications LLC, +1-608-850-4745, kemblem@mac.com
Web site: http://www.biovex.com/
