BioVex Announces Publication of Phase 2 Melanoma Results With OncoVEX (GM-CSF) in the Journal of Clinical Oncology

BioVex Announces Publication of Phase 2 Melanoma Results With OncoVEX (GM-CSF)
in the Journal of Clinical Oncology
Complete durable eradication of disease achieved in a significant number of
patients with investigational therapy for advanced Stage III and Stage IV
melanoma

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.

"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.

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 the OPTiM(TM) Phase 3 Study
BioVex has now begun a multi-national, randomized Phase 3 OPTiM Study to
assess the efficacy and safety of treatment with OncoVEX (GM-CSF) as compared
to subcutaneously administered GM-CSF in patients with unresectable Stage III
(b-c) and Stage IV (M1a-c) melanoma. The primary endpoint is the rate of
durable (maintained for six months) objective response. A total of 360
patients will be enrolled (240 to the OncoVEX arm and 120 to the control arm).
The study design was agreed with the Food and Drug Administration (FDA) under
the Special Protocol Assessment (SPA) process, which provides agreement with
the FDA that the trial's design, clinical endpoints and statistical analysis,
if the study is successful, are appropriate to be used as the basis for
regulatory approval.

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.

Treatment of melanoma depends on the stage of the disease with surgical
resection being effective in the early stages of the disease. However,
survival rates for the later Stage III and Stage IV patients are poor,
reflecting the lack of effective drugs for recurrent or metastatic disease.
Current systemic therapies are not generally effective in terms of generating
durable responses or in impacting survival. As a result, many patients
presenting with metastatic disease are directly enrolled into a clinical
trial. The vast majority of experimental therapies to date have failed to show
more than a single digit durable response rate.

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.

About BioVex
BioVex is a privately held biotechnology company based in Woburn, MA where it
also has an operational launch grade manufacturing facility. The Company is
developing a new class of potent biologics for the treatment of cancer and
prevention of infectious disease.

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.

For further information, please go to www.biovex.com.

SOURCE BioVex Inc

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