OncoSec Medical Inc. (OTCQB: ONCS),
a company developing its advanced-stage ImmunoPulse DNA-based
immunotherapy to treat solid tumors, announced today that the company
has submitted a protocol addendum to the FDA and institutional IRBs to
evaluate an increased dose frequency for ImmunoPulse in an expansion of
its ongoing Phase II melanoma trial. The Company expects to
enroll up to 21 patients in this expansion, and expects two additional
key cancer centers as sites participating in this study.
The protocol addendum will allow for the assessment of the safety and
efficacy of a six-week treatment cycle with ImmunoPulse in up to 21
melanoma patients. Each cycle will consist of treatments on Days 1, 8
and 15. Subjects will be eligible for an additional cycle as early as
six weeks from the first treatment up to a maximum of nine treatment
cycles. The protocol addendum will provide an opportunity to assess
whether more frequent treatment with ImmunoPulse can provide additional
clinical benefit to melanoma patients. The protocol addendum is also
intended to help optimize the treatment design of the Company's Phase
IIb study in melanoma patients, which is expected to initiate in late
2014. Safety of this intensified dose regimen will also be assessed.
"ImmunoPulse is a novel intratumoral immunotherapy that has demonstrated
promising efficacy for patients with advanced melanoma, while also
demonstrating a favorable safety profile," said Robert Pierce, M.D.,
Chief Medical Officer at OncoSec. "As we near completion of enrollment
of our ongoing Phase II study-with 29 out of a total of 30 patients
enrolled-we look forward to improving upon already promising results by
increasing the frequency of treatments, effectively providing 'booster
shots' for the patient's anti-tumor immune response. To date, we have
been pleased to see that approximately 60 percent of patients treated
with ImmunoPulse exhibit a systemic anti-tumor immune response,
evidenced by objectiveregression in at least one untreated lesion. By
providing an enhanced immunologic 'boost,' we are looking to maximize
patients' anti-tumor responses."
Adil Daud, M.D., Principal Investigator for the Phase II melanoma study,
said, "Data from both studies of ImmunoPulse to date have showed
encouraging results in not only the treated lesions, but in lesions that
we left untreated as well. We are looking forward to enrolling the first
patient in the expansion phase of this trial."
In the current trial design, subjects are eligible to receive one
treatment cycle every 12 weeks. Based on interim analysis through Day
180 of the first 21 subjects, it was shown that 38.1 percent (eight out
of 21) of patients achieved an objective overall response by modified
RECIST v1.1, defined as a = 30 percent reduction in the summed size of
lesions. At the time of this interim analysis, six patients (28.6
percent) had demonstrated a partial response, and two patients (9.5
percent) had achieved a complete response, lasting at least six
months. An additional 9.5 percent (two out of 21) of patients exhibited
clinically beneficial disease stabilization for at least three months.
Moreover, no treatment-related severe adverse events (SAEs) were
reported and there were no adverse events (AEs) greater than grade two,
and AEs were generally limited to transient pain related to
About OncoSec Medical Inc.
OncoSec Medical Inc. is a biopharmaceutical company developing its
advanced-stage 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 positive safety and preliminary efficacy in the treatment
of various skin cancers, as well as the potential to initiate a systemic
immune response without the toxicities associated with other systemic
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 efficacious
combination 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.
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