In Vivo is part 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

UsernamePublicRestriction
UsernamePublicRestriction

Maxim withdraws Ceplene NDA

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Maxim is withdrawing the NDA for use of its H2 receptor antagonist Ceplene (histamine dihydrochloride) in malignant melanoma patients with liver metastases, the firm announces Nov. 1. "Our focus has shifted to potential filings for…acute myeloid leukemia based on our positive Phase III trial reported this summer, as well as partnering efforts for both Ceplene and our apoptosis compounds," Maxim says. Negative results for a confirmatory Phase III trial in advanced malignant melanoma were reported in September; the company said it would evaluate whether to pursue the indication (1Pharmaceutical Approvals Monthly Oct. 1, 2004, In Brief)...

You may also be interested in...



Additional Ceplene trial needed

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...

Maxim Ceplene fails melanoma study

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...

Keeping Track: US FDA Clears Esperion’s Nexletol, Baudax’ Anjeso, Agile’s Twirla

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

Topics

UsernamePublicRestriction

Register

PS002705

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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

Cancel