SAN DIEGO, CA, January 15, 2013 — OncoSec Medical Inc. (OTCBB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumor cancers, announced the company’s upcoming milestones for 2013 at the Biotech Showcase conference held January 7-9 in San Francisco, CA.
“2012 marked a critical year for OncoSec,” said Punit Dhillon, President and CEO. “We launched three Phase II clinical trials, and our interim data from our melanoma and Merkel cell carcinoma studies provided an encouraging signal for our company to move forward with further clinical development. We understand that Merkel cell carcinoma is an aggressive skin cancer with no currently approved therapies. OncoSec is conducting the only exclusive Phase II clinical study for this orphan disease, and if successful, we look forward to launching a pivotal program later this year with the aim of bringing new hope to these patients.”
OncoSec Medical met almost every milestone set in 2012, and plans to continue the positive momentum in 2013. More than seven million dollars was raised in the fourth quarter of 2012 from fundamental institutional investors, positioning the company with a strong balance sheet to fund operations well into Q2 2014.
Key milestones that OncoSec looks forward to accomplishing for 2013 include:
- Present interim response data from OncoSec’s Phase II melanoma trial along with long-term progression-free survival (PFS) data from its previous Phase I melanoma program
- Present final data from OncoSec’s Phase II melanoma trial and Merkel cell carcinoma trial
- Conduct an end-of-Phase II meeting with the FDA for OncoSec’s melanoma and Merkel cell carcinoma program
- Present interim data from OncoSec’s Phase II cutaneous T-cell lymphoma program
- Plan to launch a pivotal Merkel cell carcinoma program
- Plan to launch a Phase IIB metastatic melanoma program
OncoSec also reviewed the significant achievements of the company during the past year.
2012: Initiated Three Phase II trials with Patients Now Enrolling in Eight Centers of Excellence Across North America
The beginning of 2012 marked the launch and development of three Phase II clinical trials in metastatic melanoma, Merkel cell carcinoma and cutaneous T-cell lymphoma. These trials are currently being conducted at eight key centers of excellence across North America, including: the University of California San Francisco, Moffitt Cancer Center, Fred Hutchinson Cancer Center at the University of Washington, and the John Wayne Cancer Institute.
2012: Presented Positive Interim Data
OncoSec’s interim data for the Phase II melanoma study showed positive safety and efficacy results with two of the patients who had met the 180-day time point. One patient showed a confirmed stable disease, while the other showed a confirmed complete response of all treated and untreated lesions. These data are encouraging and so far support findings from the Phase I study that demonstrated treatment with ImmunoPulse not only causes regression of treated lesions, but also can result in regression of untreated distant metastatic lesions as well. Unlike the Phase I study, subjects in the Phase II study are eligible for up to four cycles of ImmunoPulse.
Positive preliminary efficacy and safety results were also reported from OncoSec’s Phase II study of ImmunoPulse in Merkel cell carcinoma (MCC) patients. MCC is a highly aggressive disease that is three times more deadly than melanoma and six times more rare. There are no currently approved therapies for this cancer, and this patient population has limited options confined to surgery, chemotherapy and radiation. The interim data suggest that ImmunoPulse may elicit increased levels of IL-12 in the tumor microenvironment, and has the potential to result in a systemic immune response without adverse safety events. Of the first five patients enrolled, the overall response rate was 20 percent. One patient, after enduring prior therapies with no significant improvement (systemic chemotherapy, radiation and surgery), showed a 70 percent regression of both treated and non-treated tumors for approximately eight months, and no new tumors over six months.
2012: Secured New Patents, Certification and In-licensing
OncoSec secured a new method of use patent for its NeoPulse program in Australia. This patent provides the necessary framework to set OncoSec up to potentially expand market opportunities as an adjunct therapy for the treatment of earlier-stage solid tumors. In addition, a device patent for the company’s OncoSec Medical System electroporation device was issued in China. The issuance of this patent gives the company a strong patent position with both its ImmunoPulse and NeoPulse programs in China, one the largest emerging oncology markets in the world.
In addition, the company also secured an exclusive license for specific patented technology from the University of South Florida Research Foundation. The license complements OncoSec’s seminal patents, particularly for the protection of the methods involved in the ImmunoPulse treatment, and specifically for the use of DNA IL-12 (including in several targeted indications). OncoSec’s patent portfolio places the company in a preeminent position within the field of electroporation-based delivery of gene-based treatments for cancer.
OncoSec received Quality Management System (QMS) certification to the International Organization for Standardization (ISO) 13485 Medical Devices standard for the design, development, manufacture and distribution of electroporation devices. The ISO certification affirms OncoSec’s quality management system and supports the potential for future commercialization of the electroporation device in Europe.
Lastly, OncoSec received authorization to CE mark the OncoSec Medical System electroporation device for use in the European Economic Area, marking an essential regulatory milestone for potential future commercialization and partnership in Europe.
2012 marked a transformative year as the company solidified its ImmunoPulse development plan and initiated several trials to advance the technology. With a strong cash position that funds OncoSec’s clinical development plans well into 2014, encouraging data from its Phase II melanoma and Merkel cell programs, a broad intellectual properly estate and a distinguished group of thought-leaders on its clinical advisory board, OncoSec is poised for a strong year ahead.
About OncoSec Medical Inc.
OncoSec Medical Incorporated (OTCBB: ONCS) develops novel OMS ElectroOncology therapies that combine its proprietary electroporation delivery technology with a chemotherapeutic or novel DNA-based immunotherapeutics. Targeted local delivery of these agents is designed to achieve selective destruction of cancerous tumors while sparing healthy normal tissue, resulting in improved functional, cosmetic and quality of life outcomes. These therapieshave achieved validating safety and efficacy data in early and late stage clinical studies of over 400 cancer patients. OncoSec’s clinical programs include three Phase II clinical trials for OMS ElectroImmunotherapy. More information is available at www.oncosec.com. Additional information may also be found at OncoSec’s Facebook , Twitter, and LinkedIn sites.
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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 ourresults 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’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.