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.
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.
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.”
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.