OncoSec Reports ImmunoPulse May Prolong Survival Based on Analysis of Long-Term Survival Data from Phase I Study in Melanoma
December 04 2014 - 12:00PM
Business Wire
23.9 Months Median Overall Survival for All
Patients (n=24)
OncoSec Medical Inc. (OTCQB: ONCS), a company developing
DNA-based cancer immunotherapies, released long-term survival
results from its Phase I study in patients with metastatic
melanoma, evaluating a single treatment cycle of intratumoral
plasmid IL-12 (pIL-12) injection with electroporation (EP). Dr.
Robert Pierce, Chief Scientific Officer at OncoSec, a co-author of
the abstract presented these data today at the Melanoma Bridge 2014
conference in Naples, Italy.
The Phase 1 dose-escalation study, which completed enrollment in
February 2007 and was first published in the Journal of Clinical
Oncology (Daud et al., 2008), established that a single treatment
cycle of intratumoral pIL-12 EP, administered on Days 1, 5 and 8,
has an acceptable safety profile and is well-tolerated. Escalating
concentrations of pIL-12 were administered in cohorts of three
patients. No dose-limiting toxicities, treatment-related serious
adverse events, or treatment-related Grade 4 or 5 adverse events
were reported. Importantly, the study also demonstrated that local
intratumoral pIL-12 EP can induce systemic responses, as evidenced
by stable disease or objective regression in non-injected,
non-electroporated lesions. Moreover, pIL-12 EP monotherapy was
shown to achieve objective responses in this initial Phase 1 trial
in patients with metastatic melanoma, with three complete responses
(CRs) observed after only one treatment cycle.
OncoSec collected data from long-term follow-up and determined
that the median overall survival for the patients in the Phase 1
study was 23.9 months. In addition, a statistically significant
difference (p = 0.0054) was observed when comparing overall
survival between patients who had a best overall response of at
least stable disease or better (median OS = 49.1 months) versus
patients who only had disease progression while on study (median OS
= 10.9 months).
Dr. Mai H. Le, Chief Medical Officer at OncoSec, stated, “The
data generated from this study provide encouraging evidence that
local, intratumoral therapy has antitumor effects in both locally
treated and systemic disease. These preliminary findings suggest
that patients who respond to intratumoral pIL-12 EP may have
improved survival. Although caution must be exercised in
interpreting the OS data, these results warrant further
investigation.”
Punit Dhillon, Chief Executive Officer at OncoSec, added, “As we
continue to advance the research and development of our
immuno-oncology platform, the long-term survival data observed in
this study are encouraging and provide further validation that
intratumoral immunotherapies may provide significant therapeutic
benefit. We are grateful to the organizers of the Melanoma Bridge
conference for providing the opportunity to share these data, and
look forward to presenting our top-line six-month primary endpoint
data from our Phase II study as well.”
About OncoSec Medical
OncoSec Medical Inc. is a biopharmaceutical company developing
its investigational ImmunoPulse intratumoral cancer immunotherapy.
OncoSec Medical's core technology is designed to
enhance the local delivery and uptake of DNA IL-12 and
other DNA-based immune-targeting agents. Clinical studies of
ImmunoPulse have demonstrated an acceptable safety profile and
preliminary evidence of anti-tumor activity in the treatment of
various skin cancers, as well as the potential to initiate a
systemic immune response without the systemic toxicities associated
with other treatments. OncoSec's lead program evaluating
ImmunoPulse for the treatment of metastatic melanoma is currently
in Phase 2 development, and is being conducted in collaboration
with several prominent academic medical centers. As the company
continues to evaluate ImmunoPulse in its current indications, it is
also focused on identifying and developing new immune-targeting
agents, investigating additional tumor indications, and evaluating
combination-based immunotherapy approaches. For more information,
please visit www.oncosec.com.
This press release contains forward-looking statements within
the meaning of the U.S. Private Securities Litigation Reform Act of
1995. Any statements in this release that are not historical facts
may be considered such “forward-looking statements.”
Forward-looking statements are based on management’s current
preliminary expectations and are subject to risks and
uncertainties, which may cause our results to differ materially and
adversely from the statements contained herein. Some of the
potential risks and uncertainties that could cause actual results
to differ from those predicted include our ability to raise
additional funding, our ability to acquire, develop or
commercialize new products, uncertainties inherent in pre-clinical
studies and clinical trials, unexpected new data, safety and
technical issues, competition, and market conditions. These and
additional risks and uncertainties are more fully described in
OncoSec Medical’s filings with the Securities and Exchange
Commission. Undue reliance should not be placed on forward-looking
statements, which speak only as of the date they are made. OncoSec
Medical disclaims any obligation to update any forward-looking
statements to reflect new information, events or circumstances
after the date they are made, or to reflect the occurrence of
unanticipated events.
Investor Relations:OncoSec Medical Inc.Jordyn
Kopin855-662-6732investors@oncosec.comorPublic Relations:Dian
Griesel Int’l.Laura Radocaj212-825-3210lradocaj@dgicomm.com
OncoSec Medical (NASDAQ:ONCS)
Historical Stock Chart
From Aug 2024 to Sep 2024
OncoSec Medical (NASDAQ:ONCS)
Historical Stock Chart
From Sep 2023 to Sep 2024