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


Maxim Ceplene fails melanoma study

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Maxim is deciding whether to pursue a malignant melanoma indication for Ceplene (histamine dihydrochloride) after the H2 receptor agonist failed a confirmatory Phase III trial for the indication, the company says Sept. 20. The 230-patient trial was conducted under a special protocol assessment and evaluated Ceplene in combination with interleukin-2 against IL-2 alone. Ceplene was not significant for the primary endpoint of duration of survival. Maxim will continue pursuit of an acute myeloid leukemia indication for Ceplene based on positive results from a three-year Phase III trial of Ceplene in combination with IL-2. "We will also conduct a review of our pipeline, our operations and resources," the firm said...

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