ZIOPHARM Oncology, Inc. ZIOP
today announced promising results from nonclinical and Phase 1 studies in
advanced melanoma using Ad-RTS-IL-12, a novel DNA-based therapeutic candidate.
Findings were presented in an oral session at the 16^th Annual Meeting of the
American Society of Gene and Cell Therapy (ASGCT), held May 15-18 in Salt Lake
City, Utah. A presentation of the study, titled "Nonclinical and Phase I
Clinical Studies with a Regulated Adenoviral Gene Delivery of IL-12 Show
Promising Clinical Activity in Unresectable Stage III/IV Melanoma," was
delivered by John Nemunaitis, M.D., Executive Medical Director of Mary Crowley
Medical Research Center.
For the studies, Ad-RTS-IL-12, utilizing RheoSwitch Therapeutic System® (RTS®)
technology, was injected intratumorally. Gene expression and protein
production were controlled through the administration of an oral activator
ligand (INXN-1001). Nonclinical studies demonstrated a dose-dependent, immune
mediated reduction in tumor volume in several different syngeneic tumor
models, which led to a Phase 1 dose-escalation study in subjects with
unresectable stage III/IV melanoma.
Study subjects (n=14) were treated in four dose cohorts of the activator
ligand. Compelling clinical activity was observed in five of seven (71
percent) patients dosed at the two highest dose levels. These five patients
experienced prominent inflammatory responses in injected and non-injected
lesions and transient increases then decreases in the size of injected and
non-injected lesions. Clinical activity in these higher dose cohorts coincided
with the highest serum levels of IL-12 and IFN-γ, including a four-fold median
increase from baseline at peak levels compared with lower dose cohorts. Flow
cytometric analyses of peripheral blood mononuclear cell (PBMC) samples also
revealed seven-fold and four-fold median increases from baseline at peak
levels in absolute CD3+ and CD8+ T cell values, respectively, compared with
lower dose cohorts. The most common related adverse events (AEs) included
fever, nausea, vomiting, fatigue and arthralgia. One death occurred in the
study, unrelated to treatment, due to septicemia secondary to cellulitis and
colitis.
Market News and Data brought to you by Benzinga APIs© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Loading...
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in