OncoSec Medical Announces Completion of Enrollment of Phase II Metastatic Melanoma Trial
Final Trial Data Expected in 6-12 Months
SAN DIEGO--(BUSINESS WIRE)-- OncoSec Medical Inc. (OTCQB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumor cancers, announced the completion of patient enrollment in a Phase II clinical trial of ImmunoPulse for metastatic melanoma patients.
The Phase II trial is evaluating efficacy of ImmunoPulse in subjects with Stage IIIb to IVa in-transit cutaneous metastatic melanoma with a primary endpoint of overall objective response (OOR) at 6 months as measured by modified RECIST. Secondary endpoints for this study will evaluate safety and tolerability, as well as local response of treated lesions at Day 90.
"We are pleased that our development milestones continue to meet our expectations. We have shown great adoption of ImmunoPulse with the clinical centers enrolling in this Phase II clinical trial for advanced-stage melanoma patients," said Punit Dhillon, President and CEO of OncoSec Medical. "We are now interested in directing the focus to data analysis and the design of our next studies for the melanoma program, including expanding the adoption across other key centers of excellence."
The ImmunoPulse trial is a single-arm, open-label and multicenter study. The trial is designed to assess local and distant response following treatment of cutaneous melanoma lesions with DNA IL-12 and electroporation with a primary endpoint of 24 weeks. One treatment cycle will consist of three treatments applied to up to four lesions on days 1, 5 and 8 with a maximum dose of 1.5 mg DNA IL-12 per treatment cycle. At 12 months, patients will be moved to the follow-up phase of the study and will be followed for up to five years for safety. This multicenter trial is being conducted in the United States at the University of California San Francisco, the University of Washington and the John Wayne Cancer Institute.
Previously, OncoSec provided an interim safety analysis of 13 patients of its Phase II metastatic melanoma program. The results showed that 95 percent of evaluable treated lesions demonstrated a response at Day 39 and Day 90. In addition, two subjects who were evaluable for the primary endpoint of overall objective response at Day 180 both demonstrated a clinically relevant objective response as measured by RECIST. In March 2013, an update of interim data was announced demonstrating durability of response of treated lesions. These data showed that all melanoma lesions that demonstrated at least a partial or complete response to treatment with ImmunoPulse had a 68 percent and 45 percent durable response at three and six months,respectively.
ImmunoPulse utilizes the DNA plasmid interleukin-12 (IL-12), which is injected directly into the tumor. After the injection, six needle-like electrodes hooked up to a generator are inserted into the skin around the tumor. Short pulses of 1,300 volts are then administered, and the electric field causes the pores of the cancer cells' membranes to temporarily open, allowing the DNA plasmid to enter directly into the open pores. Upon entry, the gene triggers each cell to produce and secrete the IL-12 protein, which in turn identifies and eliminates cancerous cells as part of a natural immune response.
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). Treatment of various solid cancers using these powerful and targeted anti-cancer agents has demonstrated selective destruction of cancerous cells while sparing healthy normal tissues during early and late stage clinical trials. 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.
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