SAN DIEGO--(BUSINESS WIRE)--
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 objective regression 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 electroporation treatment.
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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OncoSec Medical Inc.
Veronica Vallejo, CFO