CHICAGO, June 1 /PRNewswire/ -- BioVex Inc, a biotechnology company
developing clinical stage treatments for cancer and the prevention of
infectious disease, today announced positive results from its Phase II
clinical trial of OncoVEX GM-CSF, an oncolytic for the treatment of
advanced metastatic melanoma, at the 2008 Annual Meeting of the American
Society of Clinical Oncology (ASCO) in Chicago, IL.
Clinical Trial Details
Phase II Trial Design: The Phase II trial was conducted at seven U.S.
clinical centers, including the Mary Crowley Cancer Research Center,
Dallas, TX; Columbia University, New York, NY; The Hubert H. Humphrey
Cancer Center, Minneapolis, MN; and the University of California San Diego,
San Diego, CA. Fifty patients with inoperable Stage IIIc/IV melanoma were
enrolled. Patients were given OncoVEX GM-CSF injections every two weeks for
up to a year. 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 >30% reduction in disease
burden. The target efficacy endpoint detailed in the Phase II protocol and
agreed with the FDA was to achieve two objective responses or stable
disease >2 months.
Phase II results: Among 43 patients currently evaluable of the 50
patients enrolled, tumors injected with OncoVEX GM-CSF routinely responded,
often with local complete responses or palliative benefit. With regard to
systemic overall responses required for treatment success (including tumor
responses at sites distant from injected tumors), six patients showed
complete clinical responses; five of which are ongoing at between four and
27 months post first injection. The sixth complete response patient
presented with a new lesion 15 months after initiating therapy. A further
six patients achieved a partial response, five of which are ongoing 7-13
months post first injection and two of which have no disease after surgical
resection of residual tumors.
The current rate of objective response stands at 28%. Other patients
have shown clinical benefit including prolonged periods of stable disease
as well as post treatment responses after being withdrawn from the study
for initial progression. Seven patients remain on study with stable disease
3 to 10 months post initiation of therapy. Side effects were mild and
mainly limited to transient flu-like symptoms.
Commenting on these results, Dr. Neil N. Senzer of the Mary Crowley
Cancer Research Center in Dallas, TX said:
"Patients with advanced melanoma have few current treatment options
that produce a lasting clinical response. OncoVEX GM-CSF has shown it can
engender durable objective responses in a substantial proportion of
patients. This efficacy profile combined with a lack of any serious side
effects makes this product candidate one of the most promising later stage
experimental cancer therapies currently in clinical development."
FDA approved pivotal Phase III study design
BioVex recently announced that the U.S. Food and Drug Administration
(FDA) has approved the design of a single, pivotal, Phase III clinical
trial evaluating OncoVEX GM-CSF in previously treated patients with
metastatic melanoma. The agreement was made under the Special Protocol
Assessment (SPA) procedure. The Phase III study design agreed upon with the
FDA follows directly from the study design successfully employed in Phase
II, incorporating a response rate based primary endpoint -- the rate of
objective responses maintained for six months or more. The study is
expected to commence in the first quarter of 2009, with a potential
projected biologics licensing application (BLA) filing in late 2010.
BioVex President and CEO Philip Astley-Sparke commented:
"OncoVEX GM-CSF is poised to become the first product in its class to
enter into a pivotal, Phase III study. I am extremely proud of the
commitment that all our management, employees and investigators have made
to ensure that this pioneering approach is now just one successful study
away from providing a new treatment modality for patients who currently
have few, if any, attractive options."
About Metastatic Melanoma
According to the American Cancer Society, more than 8,000 people died
in the U.S. of melanoma in 2007. 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 less severe, non-metastatic forms of
the disease. However, survival rates for later Stage III and IV patients
are poor, reflecting the lack of any efficacious drugs for metastatic
disease. Current systemic therapies are not generally effective in terms of
generating durable responses or in impacting survival and therefore many
patients presenting with metastatic disease are directly enrolled into a
clinical trial. The vast majority of experimental therapies have failed to
show more than a single digit durable response rate.
About BioVex
BioVex is a privately held biotechnology Company based in Woburn, MA.
The Company is developing a new class of potent biologics for the treatment
of cancer and prevention of infectious disease.
The Company's lead cancer technology platform, OncoVEX GM-CSF, is an
unpartnered, first-in-class oncolytic, or cancer destroying virus
technology. OncoVEX GM-CSF works by: replicating and spreading within solid
tumors, causing the death of cancer cells; while stimulating the immune
system to destroy 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 generated to date, coupled with a benign side effect profile.
BioVex is currently completing a Phase II clinical trial of OncoVEX
GM-CSF for melanoma and Phase I/II clinical trials for head & neck cancer
and pancreatic cancer. The Company recently announced that the FDA has
approved the design of a single, pivotal Phase III clinical trial
evaluating OncoVEX GM-CSF in previously treated patients with metastatic
melanoma under the Special Protocol Assessment (SPA) procedure and plans to
make a second SPA submission for head & neck cancer later in the year.
The Company's second program is a vaccine for genital herpes, ImmunoVEX
HSV2, which provides complete protection in animal models of the disease. A
Phase I study with ImmunoVEX HSV2 is scheduled to commence in the third
quarter of 2008.
For further information, please go to http://www.biovex.com.
See Also
- Cell-Mediated Immunity and Anti-HLA Antibody Tests Provide Insight to Immune Response in Renal Transplant Patients
- Lake Mohawk Gallery of Emryn International LLC will be Featuring the Oil and Pastel Paintings of Laurie Harden
- Lipstick to Lipsense
- Sunesis Pharmaceuticals Presents Updated Clinical Data From Ongoing Phase 2 Trial of Voreloxin (Formerly SNS-595) in Ovarian Cancer Patients at the 44th ASCO Annual Meeting
Via: Healthcare
0 коментарі:
Post a Comment