OncoSec Medical Reports Positive Preliminary Efficacy Results from
Phase II Study of ImmunoPulse in Metastatic Melanoma Patients
SAN DIEGO, Nov. 15, 2012 /PRNewswire/ -- OncoSec
Medical Inc. (OTCBB: ONCS), a company developing its advanced-stage
ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat
solid tumors, announces positive preliminary results from a Phase
II trial investigating the use of ImmunoPulse in metastatic
melanoma patients at the 6th World Meeting of Interdisciplinary
Melanoma Skin Cancer Centres & 8th EADO Congress. This
preliminary interim analysis of 13 out of 25 patients supports key
findings from a Phase I trial suggesting that ImmunoPulse is able
to induce regression or stabilization of distant untreated
metastases following a single cycle of treatment.
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A total of up to 25 patients with stage III or IV cutaneous and
in-transit metastatic melanoma will be enrolled in this Phase II,
single-arm, open-label and multi-center study. The trial was
designed to assess local and distant objective response following
treatment of cutaneous melanoma lesions with ImmunoPulse. As per
the protocol, a preliminary interim analysis was scheduled upon
completion of 50 percent enrollment in the study.
The purpose of the analysis was to confirm safety and efficacy
observed in the Phase I study. At the time of this preliminary
interim analysis, 13 patients were enrolled and treated. Thirteen
subjects were evaluable at Day 39, nine at Day 90, and two at Day
180. Ninety-five percent of treated lesions demonstrated response
at Day 39 (5 percent progressive disease, 14 percent stable disease
(SD), 42 percent partial response (PR), 39 percent complete
response (CR)). All treated lesions at Day 90 (5 percent SD, 50
percent PR, 45 percent CR), and at Day 180 (33 percent PR, 67
percent CR) demonstrated a response. At Day 180, two subjects were
evaluable for the primary endpoint of objective overall response
(ORR). One patient has a confirmed stable disease, and the second
patient has a confirmed complete response of all treated and
untreated lesions. Analysis of the safety data for the subjects
analyzed confirms that intratumoral administration of DNA IL-12
with electroporation is safe and well-tolerated. No related adverse
events reported were greater than grade 2, and were generally
limited to transient pain related to electroporation treatment.
The preliminary results are being presented in a poster titled
"Preliminary Analysis of a Phase II Trial of Intratumoral Delivery
of Plasmid Interleukin-12 (pIL-12) with In Vivo
Electroporation in Patients with Metastatic Melanoma." Dr.
Adil Daud, principal investigator
and co-director of melanoma research at the University of California San Francisco School of
Medicine, is co-author.
These data are also being orally presented at a parallel
scientific symposium, hosted by OncoSec, titled
"Electrogenetherapy: Intralesional Immunotherapy Approach for Skin
Cancers Using Electroporation." Drs. Adil
Daud and Axel Hauschild will
chair the event, which will be held on Thursday, November 15 from 6:00-7:00pm Barcelona time. The agenda is as follows:
- Application and Versatility of Electrogenetherapy – Dr.
Richard Heller
- Clinical Experience: Case presentation and discussion of
intralesional injection of plasmid interleukin-12 with
electroporation – Dr. Adil Daud
- Immune correlates and biomarkers: Immune related responses
following intralesional injection of plasmid interleukin-12 with
electroporation – Dr. David Weiner
and Dr. Edward Cha
- Outlook on intralesional immunotherapies for the treatment of
metastatic melanoma – Dr. Adil
Daud
Punit Dhillon, President and CEO
of OncoSec Medical, commented, "We are encouraged to have observed
at least one complete response based on the evaluable patients that
have met the primary endpoint timeline, and we will continue to
follow this patient and the others to assess the durability of
response. These data validate the results from the Phase I study
and effort we have put into this program, while providing further
evidence of the potential role of ImmunoPulse as a safe and
effective option for treating this aggressive disease."
Dr. Daud commented, "Preliminary results from this Phase II
study appear to offer solid support to the earlier study indicating
the efficacy of ImmunoPulse in treating metastatic melanoma.
Enrollment in the study is ongoing and expected to be completed by
the end of 2012. Long-term follow-up will assess durability of
response."
About the Phase II ImmunoPulse Study
A total of up to 25 patients with stage III or IV cutaneous and
in-transit metastatic melanoma will be enrolled in this Phase II,
single-arm, open-label and multi-center study. The trial is
designed to assess local and distant objective response following
treatment of cutaneous melanoma lesions with DNA IL-12 and
electroporation with a primary endpoint of 24 weeks. One treatment
cycle will consist of three treatments applied to up to four
lesions on days 1, 5 and 8 with a maximum dose of 1.5 mg DNA IL-12
per treatment cycle. At 12 months, patients will be moved to the
follow-up phase of the study and will be followed for up to five
years for safety.
About Melanoma
Melanoma is the most serious form of skin cancer. If it is
recognized and treated early, it is almost always curable, but 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 US 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, there remain few treatment options 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 dramatically
enhance the delivery and uptake of a locally delivered
DNA-based immunocytokine (ImmunoPulse) or chemotherapeutic
agent (NeoPulse). Treatment of various solid
cancers using these powerful and
targeted anti-cancer agents has
demonstrated selective destruction of cancerous
cells while sparing healthy normal tissues during early and
late stage clinical trials. OncoSec's clinical programs include
three Phase II 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.
SOURCE OncoSec Medical Inc.