Pink Sheet 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

DFMO IN PHASE I NCI CANCER CHEMOPREVENTION TRIALS

Executive Summary

DFMO IN PHASE I NCI CANCER CHEMOPREVENTION TRIALS are under way at Roswell Park Hospital in Buffalo, N.Y. The National Cancer Institute is sponsoring the study to look at the effect of eflornithine (DFMO) use in "higher than normal risk" patients who still have polyps and are post-resection for breast cancer and other carcinomas. The six-month study is set to include 25 patients; 20 patients are currently receiving the drug. The immediate endpoint of the study is the presence of polymene pools in the red blood cells and their relationship to toxicity. Biochemical changes associated with cancer are known to decrease in pools of polymenes. Marion Merrell Dow is developing the anti-protozoale/anti-prypanosomal agent under the brand name Ornidyl (eflornithine). The company filed an NDA in August 1988 for an orphan indication in the treatment of African sleeping sickness. In addition, the company is reportedly conducting Phase III trials for an orphan indication in the treatment of Pneumocystis carinii pneumonia (PCP) infections related to AIDS. Marion Merrell Dow reportedly is not involved in the Roswell Park chemoprevention work. Roswell Park is planning another NCI-sponsored cancer chemoprevention trial in early 1991 to test N-acetylcysteine . This study looks to measure the ability of the drug to affect intracellular, sulfidial-containing compounds such as plutothyone. The study design will be similar to the DFMO trial, enrolling 20 to 25 patients to receive daily oral administration that will increase in the absence of toxicity.

You may also be interested in...



Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth

UsernamePublicRestriction

Register

ID007083

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