We’ve had a busy year at OncoSec. From our ongoing clinical trials to the formation of our melanoma board, research agreement with Old Dominion University and in between, the last year has moved us deeper into cancer research and engaging with patient communities. As we have only a matter of days left in 2013, we would like to look back at this year in review. Here is a selection of some of our activities this year:
SAN DIEGO, CA, January 24, 2012 — OncoSec Medical Inc. (OTCBB:ONCS), which is developing its advanced-stage OncoSec Medical System (OMS) ElectroOncology therapies to treat solid tumor cancers, today announced that Michael Cross, Ph.D., Chief Business Officer at OncoSec, will be presenting at the World Cancer Immunotherapy Conference in San Diego, January 25-26, 2012.
World Cancer Immunotherapy Conference
Hilton San Diego Gaslamp Quarter
401 KStreet, San Diego, CA
United States 92101
January 25-26, 2012
January 25, 2012
The World Cancer Immunotherapy Conference is bringing together leading scientists and C-Level executives from across the globe topresent research, case studies and viewpoints on various topics integral to a better understanding of the challenges and opportunities facing developers of therapeutic cancer vaccines.
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.
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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.
Preliminary Results of Phase IV Head & Neck Cancer Trial Demonstrate Primary Endpoint Was Achieved; Final Results of Phase I Breast Cancer Trial Show 77% Response Rate
SAN DIEGO, CA, September 26, 2011 — OncoSec Medical Incorporated (OTCBB: ONCS), which is developing its advanced-stage OMS ElectroOncology™ therapies to treat solid tumor cancers, announced today clinical study results presented at the Fire, Ice and Beyond: The Future of Ablation Therapies conference in Las Vegas, NV, September 23-24. OncoSec’s exhibition highlighted a poster titled, “OMS ElectroChemotherapy: Targeted Ablation of Solid Tumors using Reversible Electroporation in Combination with Bleomycin,” which provided preliminary results from their Phase IV head and neck cancer trial and final clinical data from the Phase I breast cancer trials carried out in Europe using OncoSec’s OMS ElectroChemotherapy™ treatment approach.
Phase I Breast Cancer Study
The FDA-approved Phase I study of 13 patients with recurrent breast cancer treated with OncoSec’s OMS ElectroChemotherapy™ demonstrated that the therapy was safe, well-tolerated, and achieved a complete response rate of 77% (10/13) for all patients treated in this study.
The open-label, single-treatment trial in patients with recurrent breast cancer following partial or complete mastectomy used intratumoral administration of bleomycin followed by electroporation to significantly enhance uptake of the drug using OMS ElectroChemotherapy™. No treatment-related serious adverse events were observed. Non-serious adverse events were “unremarkable” during a 30-day follow-up period. Thirteen patients (15 tumors) were enrolled in this study. Excluding one patient lost to follow-up, 10 of the 12 evaluable patients (83%) met the criteria for Complete Response (CR) at 24 weeks.
“The result of this Phase I trial indicates the potential for this local treatment of recurrent breast cancer following partial or complete mastectomy and merits further evaluation,” stated Dr. Paul Goldfarb, OncoSec’s Medical Director.
Preliminary: Phase IV Head & Neck Cancer
This Phase IV registration trial carried out in Europe enrolled 92 patients (53 males and 39 females) with 66 patients followed for up to two years. Mean age at enrollment was 61.0 years (range 20 – 86 years). Seventy-six percent of tumors treated were primary cancers, and 23% were recurrent cancers, with a mean tumor volume for all cancers of 19 cm3. Treatment was found to be safe and well-tolerated with majority of adverse events being pain (77%), infection (50%), edema (48%), and dysphagia (30%). Patient survival following treatment at 8 months was 95% (87/92) and 86% (79/92) at 24 months. In addition, 83% (19/23) of patients with primary tumors treated with bleomycin and electroporation alone at 8 months were disease free. The mean time to onset of recurrence was 379 and 276 days for primary and recurrent disease, respectively. Preliminary analysis of this data demonstrates that the primary endpoint, local control of the tumor at 8 months, was achieved.
A subset of the study results from this Phase IV Recurrent and Primary Cutaneous Head & Neck Cancer Study was published by investigators from Orebro University Hospital in Orebro, Sweden in the medical journal Dermatological Surgery, August 2010, in a paper entitled, “Electroporation Therapy of Skin Cancer in the Head and Neck Area.” A second subset of results from this study was more recently published by the same group of investigators in the journal Acta Oto-Laryngologica, June 2011, in a paper entitled, “Electroporation therapy for T1 and T2 oral tongue cancer.”
Dr. Lennart Lofgren, principal investigator at Obrebro University Hospital and author of the above mentioned articles, said, “OMS ElectroChemotherapy™ has demonstrated promising safety and efficacy results in this patient population, in addition to providing superior functional and cosmetic outcomes for those patients with recurrent or otherwise complicated and difficult to treat skin cancers. This simple and novel delivery of bleomycin, an approved chemotherapeutic agent, through reversible electroporation has shown a marked improvement in potency, while delivering a much lower and safer concentration of the drug.”
“With positive results from these multiple clinical studies, OMS ElectroChemotherapy™ demonstrates clinical benefit for patients with manageable side effects,” said, Punit Dhillon, president and CEO. “We strongly believe in the clinical relevance of our therapeutic approach and believe these results demonstrate tolerability, efficacy and point to the combinability of this novel treatment approach with current available therapies for the management of local tumors. Clinical experience from these programs supports the uniqueness of OMS ElectroChemotherapy™ in its ability to achieve selective destruction of cancerous tumors while sparing healthy normal tissue including highly vascularized and innervated surrounding structures, providing physicians with an important flexible treatment alternative.”
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. More information is available at www.oncosec.com.
Article Highlights OncoSec’s Entry Into Three Phase II Trials for Skin Cancer
SAN DIEGO, CA, August 15, 2011 — OncoSec Medical Incorporated (OTCBB: ONCS), which is developing its advanced-stage OMS ElectroOncology therapies to treat solid tumor cancers, announced today that a profile of the company and its pipeline of oncology therapies is featured in the most recent issue of BioWorld, one of the most widely read publications in the pharma and biotech industries. The article can be purchased at www.bioworld.com.
The publication noted that: “The San Diego-based biotech has yet to celebrate its first anniversary, but its lead electro immunotherapy candidate, DNA IL-12, is heading into three Phase II trials for melanoma, Merkel cell carcinoma and cutaneous T-cell lymphoma (CTCL). The company attributes its enviable maturity to its March spin-out from Inovio Pharmaceuticals Inc., of Blue Bell, Pa. The move allowed Inovio to focus on DNA vaccines, while giving OncoSec the opportunity to develop electrochemical and cytokine-based immune therapies for treating solid tumors via electroporation delivery.”
A previous Phase I trial provided further evidence that a DNA plasmid encoded to produce IL-12 delivered by electroporation into melanoma lesions induces responses to known and novel antigens, resulting in regression of local treated lesions as well as distant untreated lesions The link below provides further information on this trial:(http://www.oncosec.com/news/oncosec-electroimmunotherapy-shows-systemic-effects-of-metastatic-melanoma-tumor-in-more-than-50-percent-of-patients).
OncoSec’s President and CEO, Punit Dhillon said, “We are pleased to receive recognition from a global biotech publication for OncoSec’s lead pipeline immunotherapeutic product. We look forward to reporting additional progress from our Phase II skin cancer trials in Q4.”
About BioWorld Today®
BioWorld® Today, the news source of record for the biotechnology industry, is read by biotechnology professionals worldwide for its hard-hitting, objective news reporting. BioWorld Today is delivered via e-mail every business morning, and is also found exclusively online at www.bioworld.com. The BioWorld online web site has been internationally recognized as the most comprehensive resource for strategic biotechnology news and information available today.
About OncoSec Medical Inc.
OncoSec Medical (OTCBB: ONCS) develops novel 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. More information is available at www.oncosec.com.