A Randomized, Double-Blind, Dose-Finding, Placebo Controlled, Phase II Multicenter Study of Tetrodotoxin in the Treatment of Chemotherapy Induced Neuropathic Pain

Inclusion Criteria:

- If female, not of childbearing potential.

- Patients with documented neuropathic pain

- Cancer Patients who have completed a chemotherapy regimen which included taxanes or
platinums (or both) and have no evidence actively progressive disease. Concurrent
hormonal therapies are allowed

- Patients with stable moderate to severe neuropathic pain

- Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status score
of 0 or 1.

- Patients who are able to complete the study-related questionnaires independently in
either English or Spanish.

Exclusion Criteria:

- History of peripheral neuropathy attributed to any cause other than chemotherapy.

- Patients receiving any concurrent agents known to cause peripheral neuropathy within
30 days of Randomization.

- Current use of other therapy (ies), including "alternative" therapies, for treatment
of peripheral neuropathy within 30 days of Randomization (with the exception of
protocol allowed concurrent medications).

- Patients who used controlled release opioids within seven days of baseline period or
who expect to use controlled release opioids at any time from baseline to end of
study.

- Patients with abnormal kidney function.

- Patients with bone metastases.

- Patients scheduled for treatment for their cancer with chemotherapy or radiotherapy
between screening and the end of study visit.

- Current use of lidocaine and other types of antiarrhythmic drugs within 30 days of
Randomization.

- Current use of scopolamine and acetylcholinesterase-inhibiting drugs such as
physostigmine within 30 days of Randomization.

- Current cause of Chemotherapy Induced Neuropathic Pain attributed to Velcade
(Bortezomib) or vinca alkaloids or analogues such as vincristine, vinblasine,
vinorelbine and vindesine.

- Current use of tricyclic antidepressant medication, anticonvulsants and monoamine
oxidase inhibitors.

- Patients with current uncontrolled asthma or lung disease.

- Patients with significant heart disease.

- Use of an investigational agent within 30 days prior to screening or is scheduled to
receive an investigational drug other than TTX during the course of the study.

- Females who are pregnant or nursing