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Matrix IntraDose

Executive Summary

Two Phase III trials of cisplatin/epinephrine injectable gel for the treatment of refractory head and neck cancer found 29% of IntraDose patients had objective tumor responses (19% complete, 10% partial) compared to 2% for placebo. Studies of 178 patients were presented at the American Society of Clinical Oncology meeting in New Orleans. The trials also assessed patient benefit goals, including pain control, obstructive symptoms, mobility, physical appearance, wound care, ability to hear, ability to smell or ability to see. Patient benefit goals were reached by 27% of the IntraDose patients and 12% of the placebo patients. The NDA will be submitted by the end of the year (1"The Pink Sheet" May 17, 1999, p. 28). Interim results of a Phase II study of IntraDose in primary liver cancer showed 55% (21 of 38 patients) responded to IntraDose therapy, including nine complete responders. Median survival times were 23 months for responders and 13 months for non-responders. Another Phase II trial in primary liver cancer will begin around the end of the year

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