OncoSec Medical Announces Positive Interim Data from Phase 2 Study of OMS-I100 in Metastatic Melanoma
December 16 2013 - 6:02AM
Business Wire
Favorable Safety Profile, Robust Response
Rates Reinforce Potential of Novel Immunotherapy
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 Francisco.
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, MD, 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 metastatic melanoma.”
About Melanoma
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.
Investor Relations:OncoSec Medical Inc.Amy Chan,
855-662-6732investors@oncosec.com
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