Interim Results of ElectroChemotherapy for Head & Neck Cancer Shows Enhanced Quality of Life in Two Randomized Phase III Studies

Data from an interim analysis of two randomized Phase III clinical trials, HNBE-01 and HNBE-02, using electrochemotherapy to treat locally recurrent and second primary squamous cell carcinoma of the head and neck (SCCHN) was announced today.

In these studies, electrochemotherapy was compared against surgery for quality of life, safety, survival and local control at eight months, where local control is defined as destruction of the treated tumor without evidence of reappearance of the tumor at the treatment site. The data show OMS ElectroChemotherapy achieved the primary endpoint of preserving quality of life compared to surgery, and appears to be safe and comparable to surgery in achieving control in locally recurrent or second primary SCCHN.

Upon receiving Investigational Review Board (IRB) approval, OncoSec rolls out a Phase II clinical trial evaluating OncoSec’s electroporation therapy for the treatment of cutaneous T-cell lymphoma. The trial takes place at the University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center.

UCSF investigators actively recruit up to 27 patients with cutaneous T-cell lymphoma and administer the first doses of the immune-stimulating agent interleukin-12 (DNA IL-12) via electroporation. One treatment cycle consists of three treatments applied to up to four lesions on days one, five and eight, with a maximum dose of 3.0 mg DNA IL-12 per treatment cycle.

OncoSec is granted a new method of use patent from the Commissioner of Patents, Commonwealth of Australia Patent Office. The patent covers the company’s OMS (OncoSec Medical System) treatment platform as a “ Method and Device for Treating Microscopic Residual Tumors Remaining in Tissues Following Surgical Resection”.

The patent offers potential for OMS technology to be used to treat the margins of solid tumors following surgical resection, thereby expanding of OncoSec’s market opportunities considerably.

OncoSec enters into an exclusive cGMP manufacturing agreement with VGXI Inc. for the production of interleukin-12 plasmid DNA (DNA IL-12). VGXI possesses a patented DNA plasmid manufacturing process essential to the production of DNA IL-12.

OncoSec administers DNA IL-12 as part of an innovative immunotherapy for treating skin cancers. With large-scale process development and clinical manufacturing of this immunotherapeutic, OncoSec has the ability to scale up production for its OMS (OncoSec Medical System) treatment activities.

OncoSec releases Phase IV study data demonstrating that chemotherapy delivered by electroporation compares favorably to standard outcomes associated with surgery for patients with head and neck cancer.

The study demonstrates local tumor control in 94% of primary and 57% of recurrent tumors as well as enhanced quality of life for patients treated via electroporation using the OncoSec Medical System (OMS). Data is taken from 81 subjects in a Phase IV study of primary and locally recurrent squamous cell carcinoma of the head and neck, each of whom was treated with OMS in a European trial. In terms of both tumor control and overall quality of life, the OMS system compares favorably to surgical intervention.

OncoSec announces the closing of a sale to institutional investors of an aggregate of 31,000,000 shares of its common stock at $0.25 per share in a registered public offering. Investors also receive warrants to purchase up to 31,000,000 shares of common stock at an exercise price of $0.35 per share for a term of five years.

The gross proceeds of the offering are $7.75 million, with net proceeds of approximately $7.2 million.

Oncosec initiates two additional enrolling sites for its Phase II metastatic melanoma clinical trials.

Both the John Wayne Cancer Institute in Santa Monica, CA, and Lakeland Comprehensive Cancer Center in Lakeland, FL are initiated as trial sites, and investigators begin screening patients.

A total of up to 25 patients with stage III or IV cutaneous and in-transit metastatic melanoma are enrolled in this Phase II, single-arm, open-label and multi-center study.

The first patient with metastatic melanoma is dosed during a Phase II clinical trial evaluating OncoSec’s OMS system.

After Investigational Review Board (IRB) approval is received by the University of California, San Francisco, UCSF investigators begin actively recruiting patients with stage III or IV cutaneous and in-transit metastatic melanoma for the trial. A total of up to 25 patients is enrolled in this Phase II, single-arm, open-label and multi-center study.

Physicians at the University of Washington and Seattle Cancer Care Alliance, in conjunction with the Fred Hutchinson Cancer Center, treat several patients in an open-label Phase II clinical trial evaluating OncoSec’s OMS electroporation therapy for the treatment of Merkel cell carcinoma.

The clinical trial is designed to test DNA IL-12 administered using OncoSec’s novel treatment approach for immunotherapy to patients with local and distant Merkel cell carcinoma. As many as 15 patients with local and distant Merkel cell carcinoma are enrolled in the trial.

OncoSec appoints three internationally recognized and respected medical innovators to its newly created Scientific Advisory Board (SAB).

This advisory board is established to provide input into the company’s R&D and clinical strategies, including OncoSec’s multiple planned Phase II clinical trials for the treatment of melanoma, Merkel cell carcinoma and cutaneous T-cell lymphoma.

Joining the SAB are: Richard Heller, Ph.D. – Director, Frank Reidy Research Center for Bioelectrics, Old Dominion University, Iacob Mathiesen, Ph.D. – CEO, Otivio AS, and Christian H. Ottensmeier, MD, Ph.D. – Professor of Experimental Cancer Research at the University of Southampton.


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