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
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/
