SPI-1005 for Prevention and Treatment of Chemotherapy Induced Hearing Loss

Safety and Efficacy Study of SPI-1005 for Prevention of Chemotherapy Induced Hearing Loss

Chemotherapy treatment with platinum based agents is well noted to cause ototoxicity. It is the objective of this study to determine the safety and efficacy of SPI-1005 at three dose levels when delivered orally twice daily for 3 days, surrounding each cycle of platinum chemotherapy in head and neck or non-small cell lung cancer patients to prevent and treat chemotherapy induced hearing loss and tinnitus.

Chemotherapy treatment with the platinum containing chemotherapies (e.g. cisplatin, carboplatin) are well noted and studied for their ability to cause ototoxicity which includes hearing loss, tinnitus, vertigo, or dizziness. It is the objective of this study to determine the safety and efficacy of SPI-1005 at three dose levels when delivered orally twice daily for 3 days, surrounding each cycle of platinum chemotherapy for head and neck or non-small cell lung cancer patients to prevent and treat chemotherapy induced hearing loss and tinnitus.

SPI-1005, a proprietary oral formulation of ebselen is a small molecule mimic and inducer of the enzyme Glutathione Peroxidase. GPx reduces reactive oxygen species (ROS) by reacting with glutathione. SPI-1005 has been shown to reduce cisplatin induced hearing threshold shift in animal studies.

Inclusion Criteria:

• Adult male and female subjects, 19-80 years of age;
• Confirmed diagnosis of advanced head and neck cancer or advanced lung cancer
• Voluntarily consent to participate in the study
• Females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to screening and throughout the study or be using one of the following acceptable birth control methods:
• IUD in place for at least 3 months prior to study;
• Barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening through study completion;
• Stable hormonal contraceptive for at least 3 months prior to study through completion of study;
• Surgical sterilization (vasectomy) of partner at least 6 months prior to study.
• Females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study, hysterectomy, or bilateral oophorectomy at least 2 months prior to study).

Exclusion Criteria:

• Subjects previously treated with chemotherapy, antibiotics, or diuretics known to cause hearing loss in the last 90 days
• History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, otologic, or psychiatric disease
• Presence of alcoholism or drug abuse
• Participation in another investigational drug or device clinical trial within 30 days prior to the study
• Female subjects who are pregnant or lactating