Marsala Biotech Inc. Announces Special Protocol Assessment with the FDA for the E10A Phase III Clinical Trial in Head and Neck Cancer

Winnipeg, Dec 12 - Marsala Biotech Inc. today announced that it has completed a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) for the Phase III clinical trial of Marsala's E10A gene therapy technology for head and neck cancer. The SPA approval acknowledges that the proposed clinical trial protocol design, clinical endpoints and planned analyses are acceptable to the FDA to support a regulatory submission. 

"We are pleased with the agreement with the FDA which provides us with a clearly defined development and regulatory pathway for E10A in head and Neck cancer", stated Dr. George Thomas, President and CEO at Marsala Biotech Inc. "E10A is an innovative targeted gene therapy approach that could offer a new treatment option for head and neck cancer patients with a better efficacy and safety profile, and also provide the Company with a significant market and growth opportunity." 

Study Design 

This will be an open-label, randomized, multi-center Phase 3 clinical trial conducted in North America and Europe, comparing E10A plus chemotherapy and chemotherapy alone for treatment of head and neck cancer. The trial will involve approximately 400 patients with an improvement in median Overall Survival as the primary efficacy endpoint. 

About Special Protocol Assessments ("SPA") 

The SPA process is a procedure by which the FDA provides official evaluation and written guidance on the design and size of proposed protocols that are intended to form the basis for a Biologics License Application ("BLA") or New Drug Application ("NDA"). Final marketing approval depends on the results of efficacy, the adverse event profile and an evaluation of the benefit / risk of treatment demonstrated in the Phase 3 clinical trial. 

About E10A 

The Company's lead therapeutic product E10A is an adenoviral based vector containing a wild-type human endostatin transgene for the treatment of head and neck cancers. Endostatin is an anti-angiogenic agent that targets the endothelial cells of blood vessels infiltrating the tumor, preventing tumor growth and metastasis. Endostatin is a known natural anti-angiogenic agent present in the human body. The gene therapy approach has many advantages, such as improved efficacy & safety, patient compliance, reduced manufacturing costs, longer half-life, and a simplified dosing regimen. Positive Phase II clinical trials in head and neck cancer have been completed and a Phase III clinical trial of E10A in head and neck cancer was initiated in April 2013 by Marsala Biotech's JV partner in China. Further clinical trials in North America and Europe will be initiated in 2015 by Marsala Biotech Inc.

About Head and neck Cancer 

Cancers that are known collectively as head and neck cancers usually begin in the squamous cells that line the mucosal surfaces inside the head and neck (for example, inside the mouth, the nose, and the throat). Alcohol and tobacco abuse along with infection with Human Papilloma Virus (HPV) could lead to a rise in the incidence of head and neck cancer. Head and neck cancer is the sixth most common cancer among men and women, with about 640,000 new cases each year worldwide. 

About Marsala Biotech Inc.

Marsala Biotech Inc. is a Winnipeg, Canada, based new drug discovery and development bio-pharmaceutical company, concentrating on new treatments for cancer. Marsala Biotech is currently focused on using a new cancer therapeutic called E10A for head and neck cancer. The Company's pipeline encompasses E10A for other solid tumors such as breast, colorectal cancer's etc, and new chemical entities (NCEs) for the treatment and management of cancer. 

For more information, please contact:
Marsala Biotech
Tel. 204-928-7200
Fax 204-453-1293