OncoSec Medical Inc. (OTCQB: ONCS), a company developing its
advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy
to treat solid tumors, today announced its melanoma development
strategy. The company plans to continue forward in its development path
to seek FDA approval for its ImmunoPulse therapy and outlines key
activities in the melanoma program that the company expects to share
more details about within the next 12 months.
Phase II Study Expansion
The company plans to move forward with an expansion study of its Phase
II trial for metastatic melanoma. The effectiveness of an accelerated
treatment cycle will be evaluated, where an additional 10 patients will
be enrolled and will receive a second cycle of treatment after three
weeks. OncoSec may amend the protocol depending on the study outcomes.
Data Announcement
OncoSec’s Phase II melanoma study completed enrollment on June 18, 2013.
Positive immune response data, confirming the systemic effects of DNA
IL-12 administered locally with electroporation, was announced at the 8th
World Congress of Melanoma meeting in July. Top-line interim clinical
data detailing available objective response rates (complete and partial
response rates at Day 180) is expected in the upcoming months.
Combination Study
OncoSec is conducting a research study with Old Dominion University to
evaluate the effects of ImmunoPulse in combination with Anti-CTLA-4,
Anti-PD-1 and Anti-PDL-1 in a melanoma mouse model. The research study
supports the company’s strategy to investigate methods that can
potentially improve response rates of front-line therapy. Moreover, a
positive outcome from these preclinical studies may result in the
ability to expand ImmunoPulse’s reach into a larger melanoma patient
population, including those with unresectable metastatic melanoma. Data
from this study is expected in early 2014.
Initiation of Phase IIb Study
While OncoSec’s current Phase II studies in metastatic melanoma and
Merkel cell carcinoma are coming to a conclusion, the company is
preparing for its next phase of development and is setting up for the
initiation of a Phase IIb trial. The Phase IIb study will be a
randomized, controlled study, providing the company with information for
a key inflection point in the development of this program.
Punit Dhillon, President and CEO of OncoSec Medical, said, “With the
completion of our last financing, OncoSec expects to be well funded to
focus on an aggressive clinical development strategy. In addition to our
clinical program, we are focusing resources on a research pipeline that
supports the expansion of clinical candidates and explores novel DNA
plasmid constructs and cytokines for other cancer indications. We hope
to continue strengthening our position in the melanoma landscape and are
excited to share our research findings and data this year.”
To view a video of Mr. Dhillon’s vision for the company’s melanoma
program, visit the website at www.OncoSec.com
or view here.
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 tumor cancers. 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). In
early and late stage clinical trials, treatment of various solid
cancers using these powerful and targeted anti-cancer agents has
demonstrated selective destruction of cancerous cells while sparing
healthy normal tissue. 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.
Copyright Business Wire 2013