Vascular Biogenics Ltd (VBLT)

[gr8db8]

By debulking the tumor mass,
VB-111 may enhance the activity of standard anticancer
agents and may be a potential candidate for
neoadjuvant therapy. Unlike other antiangiogenesis
approaches designed to block specific cellular
steps in processes leading to new blood vessel production
or cellular proliferation, VB-111 destroys
existing vascular endothelial cells. VB-111 may be
effective both as a monotherapy and neoadjuvant
therapy and in combination with chemotherapy or
radiotherapy. It may be applicable to many different
types of solid tumors where vascularization is a
key driver of growth and metastasis.

In preclinical studies in multiple tumor models,
VB-111 was tumor-tissue specific and did not significantly
damage normal tissues or blood vessels.
In vitro, VB-111 induced a dose-dependent apoptotic
death in HUVEC but not in non-endothelial
cells, confirming its specificity. In in vivo studies
using the Lewis lung metastasis mouse model,
VB111 was safe and active only in metastatic lesions
and, with one injection, reduced tumor burden
of lung metastases by 90% in a dose-dependent
manner. IN this same animal model, the addition
of VB-111 enhanced the activity of Sutent. An
additive effect was also observed when mice were
treated with VB-111 and doxorubicin. VB-111
was similarly efficacious in other tumor models.
Overall, VB-111 was found to be safe and tissue
specific with a dual mode of action as an angiogenic
inhibitor and VDA (Breitbart A, et al., AACR10,
Abs. 1369). Based on these preclinical results, VB-
111 entered clinical trials in November 2007.

In a completed phase I clinical trial (protocol ID:
GT-111001; NCT00559117) VB-111 was administered
as a single IV infusion at escalating doses
ranging from 1x106
to 3x1012 viral particles (VP)
in 6 successive cohorts. Between November 2007
and August 2009, 27 patients enrolled at two cancer
centers. VB-111 was well tolerated; no DLT
≥Grade 3 were observed. As expected from the
specificity of VB-111 the Fas chimeric transgene
was not expressed in the blood. Disease stabilized
on day 56 in one of the 15 patients in cohorts 1
to 5. Among the 12 patients in cohort 6, disease
stabilized in 4 on day 56, and there was a PR in
one patient with papillary thyroid carcinoma that
persisted for 12 months post dosing. VB-111 was
safe and well tolerated in patients with advanced
metastatic cancer at a single administration of up
to 3x1012 VP. MTD has not been reached (Triozzi
P, et al., AACR10, Abs. 1361). Currently, the drug
is in phase II clinical trials in relapsed glioblastoma
multiforme (GBM) and advanced differentiated
thyroid cancer.

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^This was written in 2011 and it's still true today.
http://www.newmedinc.com/futonc/sample.pdf