|[December 16, 2013]
OncoSec Medical Announces Positive Interim Data from Phase 2 Study of OMS-I100 in Metastatic Melanoma
SAN DIEGO --(Business Wire)--
OncoSec Medical Inc. (OTCQB:ONCS), a company developing its
advanced-stage ImmunoPulse DNA-based immunotherapy to treat solid
tumors, today announced positive interim data from its ongoing Phase 2
trial of OMS-I100 in the treatment of metastatic melanoma. The results
were presented by principal investigator Adil Daud, MD, at the Advances
in Cancer Immunotherapy meeting at the University of California San
Data from the multicenter, open-label, single-arm study confirm the
safety of OncoSec's lead product candidate, ImmunoPulse, which leverages
the company's OMS electroporation technology to deliver the anti-tumor
agent pIL-12 directly into the tumor. In Phase 1 and Phase 2 studies, a
total of 47 melanoma patients have been treated to date without a single
drug-related, serious adverse event.
Patients treated in OMS-I100 also demonstrated positive response rates
based on RECIST criteria, the gold standard measure of solid-tumor
response to treatment. Interim efficacy analysis of 21 evaluable
patients on Day 180 indicated that 38.1% (8/21) achieved an objective
overall response, defined as =30% reduction in summed size of
lesions. At the time of this interim analysis, six patients (28.6%) had
demonstrated a partial response, and two patients (9.5%) had achieved a
complete response, lasting at least 6 months. An additional 9.5%
(2/21) of patients exhibited clinically beneficial disease stabilization
for at least 3 months.
These data strengthen and expand upon previously reported Phase 1
results, which indicated a complete response in 16% of patients (3/19)
and disease stabilization in 38% (7/19). These data were published in Journal
of Clinical Oncology in 2008.
Importantly, 61.1% of patients (11/18) with evaluable lesions exhibited
systemic antitumor immune responses, as evidenced by objective
regression (=30% reduction in size) in at least one untreated lesion.
"The response rate of untreated tumors suggests an induction of systemic
antitumor response, without systemic toxicity," commented Dr. Daud. "We
will continue to assess the responses of our remaining patients and look
forward to sharing our findings."
Robert H. Pierce, D, OncoSec's chief medical officer, added, "Systemic
response is significant for two main reasons. First, it suggests that
unlike most locally administered melanoma treatments, ImmunoPulse may
induce antitumor response throughout the entire body, which would have
clear benefits in the treatment of metastatic disease. Secondly, the
favorable safety profile of ImmunoPulse indicates its potential to
deliver systemic benefit, without the toxicities associated with many
other systemic treatments. We are therefore highly encouraged by this
finding, combined with the safety and primary efficacy data, and look
forward to continuing our investigation of OMS-I100 in the treatment of
Melanoma is the most serious form of skin cancer. If it is recognized
and treated early, it is almost always curable. If it is not, the cancer
can advance and spread to other parts of the body, where it becomes hard
to treat and can be fatal. While it is not the most common of the skin
cancers, it causes the most deaths. The American Cancer Society
estimates that at present, about 123,000 new cases of melanoma in the
U.S. are diagnosed in a year, resulting in approximately 10,000 deaths.
Melanoma originates in melanocytes, the cells that produce the pigment
melanin that colors our skin, hair, and eyes. The majority of melanomas
are black or brown, but often they can also be skin-colored, pink, red,
purple, blue or white. Currently, few treatment options remain for
patients with late-stage metastatic disease that can extend survival for
the broad population.
About OncoSec Medical Inc.
OncoSec Medical Inc. is a biopharmaceutical company developing its
advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy
to treat solid tumors. ImmunoPulse and NeoPulse therapies address an
unmet medical need and represent a potential solution, for less invasive
and less expensive therapies that are able to minimize detrimental
effects resulting from currently available cancer treatments such as
surgery, systemic chemotherapy or immunotherapy, and other treatment
alternatives. OncoSec Medical's core technology is based upon its
proprietary use of an electroporation platform to enhance the delivery
and uptake of a locally delivered DNA-based immunocytokine (ImmunoPulse)
or chemotherapeutic agent (NeoPulse). Treatment of various solid
cancers using these targeted anti-cancer agents has
demonstrated selective destruction of cancerous cells while potentially
sparing healthy normal tissues during early and late stage clinical
trials. OncoSec's clinical programs include three Phase 2 clinical
trials for ImmunoPulse targeting lethal skin cancers. More information
is available at http://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.
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