Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Additional Ceplene trial needed

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA's request for another Phase III trial for Maxim's Ceplene for acute myeloid leukemia means the company will need a corporate partner, the firm says Jan. 18. The immunomodulator met the primary endpoint of leukemia-free survival in combination with interleukin-2 in the prior 320-patient Phase III study. Maxim withdrew its first NDA for Ceplene, for malignant melanoma (1Pharmaceutical Approvals Monthly Nov. 1, 2004, In Brief). Maxim remains in discussions with FDA regarding trial design, and is discussing the need for another AML trial with European regulators...

Related Content

Maxim withdraws Ceplene NDA





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts