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.
Copyright Business Wire 2014