OncoSec Completes Patient Enrollment in Phase II Extension Study of ImmunoPulse™ IL-12 in Melanoma
SAN DIEGO, March 2, 2016 /PRNewswire/ -- OncoSec Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, today announced the completion of patient enrollment in the Company's Phase II extension study of its investigational product ImmunoPulse™ IL-12 for the treatment of advanced melanoma. The trial's objective is to evaluate an alternate dosing frequency and additional biomarkers to provide further scientific understanding of ImmunoPulse™ IL-12 in an extension of the OMS-I100 Phase II melanoma trial. The Company expects to report consolidated data from the OMS-I100 and extension studies by Q3 2016.
"We are committed to improving the lives of patients with advanced melanoma and are pleased to have completed enrollment in this Phase II study," said Punit Dhillon, President and CEO of OncoSec. "Completing enrollment in this study is an important step in the development for ImmunoPulse™ IL-12 as it allows us to build upon our positive Phase I and II results and inform our ongoing and future trials. There is a significant opportunity to bring forward a new generation of intratumoral immunotherapies for patients with melanoma who typically don't respond to first-line immunotherapies due to a low-TIL (tumor-infiltrating lymphocyte) phenotype. Our intention is to use the results from this study along with data from our OMS-I100 Phase II trial to formulate a combination registration path for ImmunoPulse™ IL-12 in melanoma."
The objective of the extension study is to assess the safety and efficacy of a six-week treatment cycle with ImmunoPulse™ IL-12 in 21 patients with advanced melanoma. The protocol extension provides an opportunity to assess whether more frequent treatment with ImmunoPulse™ IL-12 can provide additional clinical benefit to patients. The details of the trial can be found at www.clinicaltrials.gov.
About OncoSec Medical Incorporated
OncoSec is a biotechnology company developing DNA-based intratumoral immunotherapies with an investigational technology, ImmunoPulse™, for the treatment of cancer. ImmunoPulse™ is designed to enhance the local delivery and uptake of DNA-based immune-targeting agents, such as IL-12. In Phase I and II clinical trials, ImmunoPulse™ IL-12 has demonstrated a favorable safety profile and evidence of anti-tumor activity in the treatment of various skin cancers as well as the potential to initiate a systemic immune response. OncoSec's lead program, ImmunoPulse™ IL-12, is currently in Phase II development for several indications, including metastatic melanoma, squamous cell carcinoma of the head and neck, and triple-negative breast cancer. In addition to ImmunoPulse™ IL-12, the Company is also identifying and developing new immune-targeting agents for use with the ImmunoPulse™ platform. For more information, please visit www.oncosec.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as "expect," "may," "will," "goal," "intention," and similar references to future periods.
Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they 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. Potential risks and uncertainties that could cause actual results to differ from those predicted include, among others, the following: uncertainties inherent in pre-clinical studies and clinical trials, such as the ability to enroll patients in clinical trials and the risk of adverse events; unexpected new data, safety and technical issues; our ability to raise additional funding necessary to fund continued operations; and the other factors discussed in OncoSec'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 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.
OncoSec Medical Incorporated
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SOURCE OncoSec Medical Incorporated
Released March 2, 2016