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

ANTI-TAC MONOCLONAL WITH RADIOISOTOPE LED TO REMISSION OF T- CELL LEUKEMIA

Executive Summary

ANTI-TAC MONOCLONAL WITH RADIOISOTOPE LED TO REMISSION OF T- CELL LEUKEMIA in three of 14 patients, in a National Cancer Institute study reported by NCI researcher Thomas Waldmann at an April 9 press briefing in New York City. The study involved patients with adult T-cell leukemia; three experienced complete remission following treatment with a mouse monoclonal antibody linked to a radioisotope, with no leukemic cells detected since. Waldmann said a total of 10 patients, including the three in remission, "had at least a 95% to 98% reduction in tumor cells, a remission of all skin lesions, a lowering of the very aggressive serum calcium, a return to normal immune function." The remaining four patients who had been failing very aggressive chemotherapy at the time of treatment, had modest responses, he said. One of the complete responders has been in remission for six months and another has been in remission for over a year, NCI said. Waldmann pointed out during his presentation that on average, patients with adult T-cell leukemia generally die within 20 weeks of diagnosis, with or without chemotherapy. The mouse monoclonal used in the study is an anti-Tac (T-cell activated) monoclonal antibody that blocks the IL-2 receptor on the T-cell. By blocking the receptor, the monoclonal prevents the growth factor IL-2 -- which is necessary for the T-cell to stay alive and divide -- from locking onto the T-cell. Waldmann explained that in an earlier trial, NCI researchers used an unmodified monoclonal to treat 20 leukemia patents. He said seven of 20 patients went into remission, three of whom had complete and long-lasting remission. One of the three was treated 28 months ago and is still in complete remission. In the first trial, "a number of the leukemic cells had gone beyond the stage where they could respond to this mouse monoclonal," Waldmann said. So in the current experiment, he and his colleagues "armed the antibody" with radioisotopes, in particular the beta-emitting isotope yttrium 90, in order to kill the cell targeted by the monoclonal. Waldmann noted that there was "modest hematopoietic toxicity" with the isotope-linked monoclonal, which was not observed with the unmodified monoclonal. NCI has recently started a Phase I trial with a humanized version of the mouse monoclonal that involves 12 patients with lymphoma or leukemia other than adult T-cell leukemia. Waldmann noted that patients must be treated in cycles over time and because patients make antibodies to the mouse monoclonals, these monoclonals have been too immunogenic for repeated therapy. He said the humanized monoclonal will enable NCI to study a wider spectrum of leukemias and lymphomas. Hoffmann La-Roche has begun Phase I trials at two centers of its SMART Anti-Tac Antibody, a humanized monoclonal, for treatment of autoimmune disorders, adult T-cell leukemia, T-cell lymphoma and Hodgkin's disease ("The Pink Sheet" Jan. 27, T&G-8). Roche acquired the rights for the monoclonal from Protein Design Labs. Waldmann's presentation was made in conjunction with Bristol- Myers Squibb's annual award of cancer research grants. The NCI researcher received a $50,000 award in recognition of his studies of the immune system that led to new ways to use monoclonal antibodies to treat leukemias, lymphomas, and autoimmune diseases, and to prevent organ and bone marrow transplant rejection. He was nominated by NCI Director Samuel Broder, MD.

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

OM011381

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