Navigation Links
Device Master File for OncoSec Medical System Completed and Submitted to FDA
Date:10/20/2011

SAN DIEGO, Oct. 20, 2011 /PRNewswire/ -- OncoSec Medical Incorporated (OTCBB: ONCS), which is developing its advanced-stage OMS ElectroOncology therapies for the treatment of solid tumor cancers, announced today the submission of its Device Master File (DMF) to the U.S. Food and Drug Administration (FDA) for its patented OncoSec Medical System (OMS) which consists of a generator and hand-held applicator. The Company has been developing the OncoSec Medical System as its lead medical device for delivering DNA based cytokines and chemotherapeutic agents for the treatment of solid tumor cancers. In numerous Phase I through Phase IV clinical trials, the OncoSec Medical System has been shown to be both safe and effective for optimizing the cellular uptake of DNA based cytokines or chemotherapeutic agents resulting in improved therapeutic benefits for the patient.

(Photo:  http://photos.prnewswire.com/prnh/20111020/LA90264)

(Logo:  http://photos.prnewswire.com/prnh/20110314/MM64943LOGO)

The DMF, which includes technical, manufacturing, clinical and non-clinical information about the OncoSec Medical System, marks an important milestone for the Company.  This regulatory filing facilitates FDA review of the complete system when any investigational clinical study application references its use.

"This DMF submission brings the OncoSec Medical System another step closer to becoming the treatment of choice for different types of solid tumor cancers," stated Punit Dhillon, President and Chief Executive Officer of OncoSec. "In a very short period of time, OncoSec has moved aggressively with its clinical and regulatory strategy, with the DMF being one important piece of that strategy. Moving forward, we will continue to demonstrate the value of our treatment approaches as our clinical studies begin."

OncoSec plans to initiate three Phase II clinical trials under physician sponsored INDs using the OncoSec Medical System to deliver DNA IL-12: OMS-I100 for the treatment of melanoma; OMS-I120 for the treatment of Merkel cell carcinoma; and OMS-I130 for the treatment of cutaneous T-cell lymphoma.

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 therapies have 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.

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'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.


'/>"/>
SOURCE OncoSec Medical Incorporated
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. U. of Md. Researchers to Develop Devices to Revolutionize Drug Research
2. New Data Shows Ongoing Benefits of Percutaneous MitraClip(R) Device for Patients With Mitral Regurgitation
3. Boston Scientific Announces CE Mark Approval for New Devices to Treat Heart Failure and Sudden Cardiac Death
4. MitraClip Device Preliminary Data Suggests Improved Heart Function and Relief from Heart Failure Symptoms in Functional Mitral Regurgitation Patients
5. Wayne State University and Oakwood Partner in New Device to Combat Congestive Heart Failure
6. New Research for Mechanical Support Devices in Pediatrics to Be Released at International Heart and Lung Transplant Meeting
7. Tepha Announces First Human Usage of Medical Devices Derived from New Class of Resorbable Polymers
8. Arbios Receives Approval From the FDA to Initiate Pivotal Trial for SEPET(TM) Liver Assist Device
9. Disc Motion Technologies Announces First Human Implants of True TSMS(TM) Device
10. Blood Pressure Lowering Effect of Hypertension Treatment Device Further Validated in New Studies
11. Device Blocking Stomach Nerve Signals Shows Promise in Obesity
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/19/2017)... The Global Effective Microorganisms (EM) Market by Manufacturers, ... and analysed the potential of Global Effective Microorganisms (EM) Market ... growth factors. The report identifies and analyses the emerging trends ... market. ... and Figures, 6 Major Company Profiles, spread across 124 pages ...
(Date:4/19/2017)... LONDON , April 19, 2017 ... to stimulate an immune response in pets such ... vaccine products are of various types such as ... Vaccines, Toxoid Vaccines, DNA Vaccines and Recombinant Vaccines. ... such as virus or bacteria, which have been ...
(Date:4/19/2017)... , April 19, 2017  Novartis today announced ... National Heart, Lung, and Blood Institute (NHLBI) of ... 58% of patients with treatment-naïve severe aplastic anemia ... treated with eltrombopag at the initiation of and ... study evaluated three sequential treatment groups, or cohorts. ...
Breaking Medicine Technology:
(Date:4/26/2017)... Aviv, Israel (PRWEB) , ... April 26, 2017 , ... ... today announced a new partnership with Med-e-Mass , the largest Electronic Medical Records ... enable Med-e-Mass to link care plan incentives to a patient’s remote health progress, empowering ...
(Date:4/26/2017)... ... ... Miami native and local periodontist Dr. John Paul Gallardo is ... in 1991 that this journey would have taken me into so many learning experiences ... Gallardo has pioneered implant dentistry innovation, evolving into an internationally recognized leader in the ...
(Date:4/26/2017)... (PRWEB) , ... April 26, ... ... which provides an agile ecosystem and domain expertise for sponsors and CROs ... randomization and trial supply management (RTSM) software platform. Bioclinica AGILE RTSM ...
(Date:4/25/2017)... KY (PRWEB) , ... April 25, 2017 , ... ... announce they have signed an agreement to be the preferred physical therapy provider ... injuries and returning them to Derby City CrossFit as quickly and effectively as ...
(Date:4/25/2017)... ... April 25, 2017 , ... A recent report from ... performance for the 2015-16 school year across Wisconsin’s public schools, charter schools, and ... important patterns in student test score performance, the report’s limited analyses fail to ...
Breaking Medicine News(10 mins):