OncoSec Medical Inc. (OTCBB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumors, announces positive preliminary results from a Phase II trial investigating the use of ImmunoPulse in metastatic melanoma patients at the 6th World Meeting of Interdisciplinary Melanoma Skin Cancer Centres & 8th EADO Congress. This 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.
A total of up to 25 patients with stage III or IV cutaneous and in-transit metastatic melanoma will be enrolled in this Phase II, single-arm, open-label and multi-center study. The trial was designed to assess local and distant objective response following treatment of cutaneous melanoma lesions with ImmunoPulse. As per the protocol, a preliminary interim analysis was scheduled upon completion of 50 percent enrollment in the study.
The purpose of the analysis was to confirm safety and efficacy observed in the Phase I study. At the time of this preliminary interim analysis, 13 patients were enrolled and treated. Thirteen subjects were evaluable at Day 39, nine at Day 90, and two at Day 180. Ninety-five percent of treated lesions demonstrated response at Day 39 (5 percent progressive disease, 14 percent stable disease (SD), 42 percent partial response (PR), 39 percent complete response (CR)). All treated lesions at Day 90 (5 percent SD, 50 percent PR, 45 percent CR), and at Day 180 (33 percent PR, 67 percent CR) demonstrated a response. At Day 180, two subjects were evaluable for the primary endpoint of objective overall response (ORR). One patient has a confirmed stable disease, and the second patient has a confirmed complete response of all treated and untreated lesions. Analysis of the safety data for the subjects analyzed confirms that intratumoral administration of DNA IL-12 with electroporation is safe and well-tolerated. No related adverse events reported were greater than grade 2, and were generally limited to transient pain related to electroporation treatment.
The preliminary results are being presented in a poster titled "Preliminary Analysis of a Phase II Trial of Intratumoral Delivery of Plasmid Interleukin-12 (pIL-12) with In Vivo Electroporation in Patients with Metastatic Melanoma." Dr. Adil Daud, principal investigator and co-director of melanoma research at the University of California San Francisco School of Medicine, is co-author.
These data are also being orally presented at a parallel scientific symposium, hosted by OncoSec, titled "Electrogenetherapy: Intralesional Immunotherapy Approach for Skin Cancers Using Electroporation." Drs. Adil Daud and Axel Hauschild will chair the event, which will be held on Thursday, November 15 from 6:00-7:00pm Barcelona time. The agenda is as follows:
- Application and Versatility of Electrogenetherapy – Dr. Richard Heller
- Clinical Experience: Case presentation and discussion of intralesional injection of plasmid interleukin-12 with electroporation – Dr. Adil Daud
- Immune correlates and biomarkers: Immune related responses following intralesional injection of plasmid interleukin-12 with electroporation – Dr. David Weiner and Dr. Edward Cha
- Outlook on intralesional immunotherapies for the treatment of metastatic melanoma – Dr. Adil Daud
Punit Dhillon, President and CEO of OncoSec Medical, commented, "We are encouraged to have observed at least one complete response based on the evaluable patients that have met the primary endpoint timeline, and we will continue to follow this patient and the others to assess the durability of response. These data validate the results from the Phase I study and effort we have put into this program, while providing further evidence of the potential role of ImmunoPulse as a safe and effective option for treating this aggressive disease."
Dr. Daud commented, "Preliminary results from this Phase II study appear to offer solid support to the earlier study indicating the efficacy of ImmunoPulse in treating metastatic melanoma. Enrollment in the study is ongoing and expected to be completed by the end of 2012. Long-term follow-up will assess durability of response."