OncoSec Medical To Relaunch Phase II Cutaneous T-Cell Lymphoma Study at Key Centers of Excellence
April 07 2014 - 6:03AM
Business Wire
Enrollment to Expand with Stanford
University
OncoSec Medical Inc. (OTCQB: ONCS), a company developing its
ImmunoPulse DNA-based immunotherapy to treat solid tumors, will
re-launch its Phase II cutaneous T-cell lymphoma (CTCL) trial under
a protocol amendment.
In July 2012, a Phase II trial using OncoSec’s ImmunoPulse DNA
IL-12 was initiated at the University of California San Francisco
(UCSF) under an FDA-approved investigator-sponsored Investigational
New Drug application (IND) with Weiyun Ai, M.D. as principal
investigator. In November 2012, this IND was transferred to
OncoSec. Following review of the protocol under OncoSec’s own
accord, the company determined that an amendment to the protocol
should be considered in order to broaden the inclusion and
exclusion criteria, implement a more patient-friendly treatment
design, and expand the exploratory endpoints for the trial. In
consultation with Key Opinion Leaders (KOLs), OncoSec has amended
the protocol, and Institutional Review Board approval is
pending.
OncoSec will expand enrollment to Stanford University, a
renowned center of excellence. Stanford is regarded as having a
large CTCL patient population and is experienced in investigating
novel therapies in this disease.
Yuon Kim, M.D. will serve as principal investigator for the
Stanford University study. Dr. Kim is an internationally renowned
expert in cutaneous lymphomas and director of the multidisciplinary
cutaneous lymphoma program at Stanford University Medical Center.
Her team of top physicians and clinical/research staff are
dedicated to providing excellence in patient care and advancing the
development of new and innovative therapies that improve patient
survival and quality of life.
Punit Dhillon, President and CEO of OncoSec, said, “Currently
available therapies for CTCL largely manage symptoms, and since
there are few effective treatments for this disease, it remains an
unmet medical need. The safety and preliminary efficacy of
ImmunoPulse is being evaluated in this study to assess the
therapeutic potential in this disease.”
“We are extremely excited to be bringing Stanford University on
board,” said Robert Pierce, M.D., OncoSec’s Chief Medical Officer.
“Plasmid IL-12 delivered without electroporation in this patient
population has provided evidence of preliminary efficacy, but has
shown to be severely toxic. We believe the safety profile observed
thus far with using electroporation to deliver plasmid IL-12, along
with the preliminary evidence of local and systemic anti-tumor
activity observed in our Phase II melanoma study, suggest that this
treatment might offer similar evidence of safety and activity in
patients with CTCL.”
In the revised protocol, all subjects will be eligible to
receive up to six treatment cycles consisting of treatment days
(Days 1 and 8) in a 28-day cycle. A total of up to 34 patients will
be enrolled in this study. Subjects will be followed for safety and
clinical evaluation every four weeks. Quality of Life will be
assessed using the Skindex29, Functional Assessment of Cancer
Therapy – General (FACT-G) and Visual Analog Scale for Pruritus
(VAS-P) instruments. Survival follow-up will occur at three-month
intervals over two years following the end of the study.
About OncoSec Medical Inc.
OncoSec Medical Inc. is a biopharmaceutical company developing
its ImmunoPulse immunotherapy to treat solid tumors. OncoSec
Medical's core technology leverages a proprietary electroporation
platform to enhance the local delivery and uptake of
IL-12 and other DNA-based immune-modulating 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 clinical programs
currently include three Phase 2 trials targeting metastatic
melanoma, Merkel cell carcinoma and cutaneous T-cell lymphoma
(http://clinicaltrials.gov/ct2/results?term=oncosec&Search=Search).
As the company continues to evaluate ImmunoPulse in these
indications, it is also investigating additional indications and
combination therapeutic 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.Veronica Vallejo,
CFO855-662-6732investors@oncosec.com
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