Positive Efficacy Results from Phase II Study of ImmunoPulse in Metastatic Melanoma; Results from Phase IV NeoPulse Trial also Encouraging

Melanoma is the most serious form of skin cancer. If it is recognized and treated early, it is almost always curable, but if it is not, the cancer can advance and spread to other parts of the body, where it becomes hard to treat, disfiguring, debilitating and often life-threatening.

While it is not the most common of the skin cancers, it causes the most deaths. The American Cancer Society estimates that at present, about 123,000 new cases of melanoma in the U.S. are diagnosed in a year, resulting in approximately 10,000 deaths.

Melanoma originates in melanocytes, the cells that produce the pigment melanin that colors our skin, hair, and eyes. The majority of melanomas are black or brown, but often they can also be skin-colored, pink, red, purple, blue or white. Currently, there remain few treatment options for patients with late-stage metastatic disease that can extend survival for the broad population.

New treatment options
OncoSec Medical Inc., a biopharmaceutical company developing advanced-stage therapeutic options to treat solid, earlier today release positive preliminary results from a Phase II trial investigating the use of ImmunoPulse DNA-based immunotherapy in metastatic melanoma patients. The data was presented at the at the 6th World Meeting of Interdisciplinary Melanoma Skin Cancer Centres & 8th European Association of Dermato-Oncology (EADO) Congressbening held in Barcelona, Spain from November 14 - 17, 2012.

The preliminary interim analysis of 13 out of 25 patients supports key findings from a Phase I trial suggesting that ImmunoPulse is able to induce regression or stabilization of distant untreated metastases following a single cycle of treatment.

The development of the OncoSec Medical System™ (OMS) may be changing that reality. The electroporation technology powering OMS has the potential to extend lifespans and enhance the quality of life for people whose cancers are resistant to conventional treatment approaches. The impact is greatest among skin cancers that are typically hardest to treat such as metastatic melanoma, Merkel cell and cutaneous t-cell lymphoma. In particular, conventional treatments for melanoma are usually highly toxic, with severe side effects that compromise the patient’s health even further.

Electrochemotherapy
Interim results from an unrelated Phase IV Study of NeoPulse in Skin Cancer Patients showed a complete response of greater than 90% in basal cell carcinoma patients and 70% in squamous cell carcinoma patients at six months. This data is included in a poster presentation (Interim analysis of an open-labeled, single-arm multicenter study of electrochemotherapy in skin cancer; P84, Saturday, November 17, 2012) lead by author Paul Goldfarb, M.D., and co-authors Lennart Lofgren, M.D., Ph.D., Axel Hauschild, M.D. and Richard Heller, Ph.D.

Significant challenges
Surgical resection of skin cancers can pose significant challenges in achieving local control while preserving normal tissue and function without the risk of cosmetic damage. NeoPulse involves the combined use of electroporation with intratumoral injection of low-dose bleomycin to treat local tumors. An evaluation of the pharmacoeconomic benefits of NeoPulse therapy suggests it could afford healthcare savings in reducing the expense and complications of reconstructive surgery to address cosmesis.

Study design
The Phase IV study was designed as an open-labeled study to measure local control and pharmacoeconomic parameters for NeoPulse in primary or recurrent squamous cell carcinoma of the skin, basal cell carcinoma as well as recurrent metastatic melanoma. Patients with primary or recurrent histologically confirmed tumors with no evidence of brain mestastases were eligible for enrollment. Safety and local control were measured. Patients received local injection of bleomycin followed by electroporation. Concomitant therapy was permitted when warranted.

Further exploration
“Based on these interim results, NeoPulse appears to provide local control with the potential advantage of preserving normal tissue, and therefore warrants further exploration as an alternative or even adjuvant treatment in cutaneous skin cancers,” Hauschild, a dermato-oncologist and professor of dermatology at the University of Kiel, Germany, and faculty member of the 6th World Meeting of Interdisciplinary Melanoma/Skin Care Centres & 8th EADO Congress, noted.

The primary goal of this phase IV cutaneous cancer study was to assess the ability of NeoPulse to control growth or recurrence of the cancer six months following treatment, equivalent to surgery as compared to historical controls, with respect to primary (new) tumors and locally recurrent tumors. The study was conducted at 15 clinical centers across Western Europe. A total of 88 patients were enrolled and received treatment. At the time of analysis, 69 of 88 (78.4%) patients were evaluable at the six-month follow-up. The complete response rate at six months among basal cell carcinomas was 92.8% and 70% among squamous cell carcinomas. Response rate of melanoma was not calculated since multiple tumors were treated with concomitant therapy. The treatment was well-tolerated. The most frequent treatment-related adverse events were pain, infection and insomnia; all were transient and manageable.

NeoPulse appears well-tolerated and able to achieve local control comparable to that of surgical resection. The potential advantage of the therapy lies with the preservation of normal tissue with improved cosmesis, avoiding the need for reconstruction in difficult-to-treat sites or those with significant innervation. Together with the possible reduction in cost associated with hospitalization for procedures involving extensive reconstruction, the approach warrants further exploration as an alternative in select cases of skin cancer.

Punit Dhillon, President and CEO of OncoSec Medical, commented “The data shows how NeoPulse might serve as an alternative to surgery that selectively destroys cancer cells without harming normal, healthy tissue. Our skin cancer program has shown a positive outcome among the class of patients who would typically be subjected to disfiguring surgery. ... We believe that NeoPulse offers a potentially significant new treatment for a variety of skin cancers.”

For more information:

- Melanoma 2012/EADO Final Program and Abstract

Copyright © 2012 InPress Media Group/Sunvalley Communication. All rights reserved.
Republication or redistribution of InPress Media Group/Sunvalley Communication content, including by framing or similar means, is expressly prohibited without the prior written consent of InPress Media Group/Sunvalley Communication. InPress Media Group/Sunvalley Communication shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Onco'Zine and Oncozine are registered trademarks and trademarks of Sunvalley Communication around the world.

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Tags: DNA-based, ImmunoPulse, Merkel, NeoPulse, OncoSec, cancer, cutaneous, difficult-to-treat, disease, electroporation, More…immunotherapy, late-stage, lymphoma, melanoma, metastatic, reconstruction, skin, t-cell

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