Products-Fight the Disease Not The Treatment

More than 640,000 people worldwide are diagnosed with head and neck cancer each year, and more than 350,000 die from the disease annually. Head and neck cancer is a group of many related diseases that mostly begin in the cells that line the mucosal surfaces in the head and neck area such as the mouth, tongue, tonsils, throat and voicebox. The term encompasses cancers of the oral cavity, salivary glands, paranasal sinuses and nasal cavity, pharynx, larynx, and lymph nodes in the upper part of the neck.

"Head and neck cancer is particularly hard to treat and if not detected early has low survival rates," commented Nancy Leupold, survivor, President and Founder of Support for People with Oral and Head and Neck Cancer (SPOHNC). "The availability of effective therapies that advance treatment and help patients live longer is very welcome news for the cancer community."

U.S. Food and Drug Administration (FDA) has approved Taxotere® (docetaxel) Injection Concentrate in combination with cisplatin and 5-fluorouracil for induction therapy of locally advanced squamous cell carcinoma of the head and neck (SCCHN) before patients undergo chemoradiotherapy and surgery.

Chikujee plans to submit a proposal to the U.S. Food and Drug Administration (FDA) regarding its proposed 505(b)(2) New Drug Application (NDA) regulatory plan for HN-DTXL and HN-PTXL (docetaxel and paclitaxel targeted drug delivery formulation). The FDA has indicated that data from a single study of approximately 25-50 patients that demonstrates the bioequivalence of HN-DTXL and HN-PTXL and Taxotere and Onxal is sufficient to support filing an NDA.