Potential breakthrough for T-Cell lymphoma patients with drug that mimics folic acid

December 10, 2008

Preliminary results of a pivotal Phase 2 clinical trial of pralatrexate (PDX), a drug that partially works by mimicking folic acid, showed a complete or partial response in 27 percent of patients with recurrent or resistant peripheral T-cell lymphoma (PTCL). PROPEL (Pralatrexate in patients with Relapsed Or refractory PEripheral T-cell Lymphoma) findings were presented by the study's principal investigator, Dr. Owen A. O'Connor of the Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center and NewYork-Presbyterian Hospital, at the 50th Annual Meeting of the American Society of Hematology (ASH) in San Francisco.

The international, multicenter PROPEL trial is the largest ever conducted in patients with peripheral T-cell lymphoma -- a biologically diverse group of blood cancers that account for as many as 15 percent of non-Hodgkin's lymphoma (NHL) cases in the United States. There are currently no pharmaceutical agents approved for use in the treatment of either first-line or relapsed or refractory PTCL, and average five-year survival is approximately 25 percent.

"These results indicate that pralatrexate produces a major durable response in patients for whom numerous prior treatments have been unsuccessful," says Dr. Owen A. O'Connor, director of the Lymphoid Development and Malignancy Program and chief of the Lymphoma Service at the Herbert Irving Comprehensive Cancer Center at NewYork-Presbyterian Hospital and Columbia University Medical Center, and associate professor of medicine at Columbia University College of Physicians and Surgeons.

Prior to enrolling in the trial, eligible patients had received a median of three (range of 1 to 12) prior systemic treatment regimens, including 16 percent of patients who had previously undergone an autologous stem cell transplant.

"Presently, there are no FDA-approved drugs for patients with PTCL, whether it is in the front-line or for patients with relapsed or refractory disease. This underscores the need for new therapies to treat this challenging disease. Pralatrexate has the potential to play a clinically meaningful role in the treatment of these patients," adds Dr. O'Connor. Pralatrexate, designed to look like the natural vitamin folic acid, disrupts DNA synthesis in tumor cells. The drug is designed to selectively accumulate in tumor cells, after which it then induces programmed cell death, or apoptosis, in the cancer cell.

A total of 109 evaluable patients received 30 mg/m2 of pralatrexate intravenously once every week for six weeks followed by one week of rest per cycle of treatment. Patients also received vitamin B12 and folic acid supplementation. Response was assessed using standard International Workshop Criteria (IWC).

In the trial, 69 percent of patients who responded did so after cycle one of therapy. The median duration of treatment in responding patients was 179 days at the time of this analysis. The duration of response exceeded three months in 17 of 29 responders (59 percent), including 6 of the 17 patients who continued on treatment. An accurate estimate of the median duration of response cannot be reported at this time due to the current length of follow up. Patients will continue to be followed until the median duration of response can be accurately estimated.

The PROPEL trial is organized by Allos Therapeutics Inc., the maker of the drug. Since PROPEL has been given fast-track status, the company will submit pralatrexate for FDA approval once the Phase 2 data has been finalized -- sometime in the first half of 2009.

Pralatrexate was developed by a team of researchers at Memorial Sloan-Kettering Cancer Center (MSKCC) and the Southern Research Institute, including Dr. O'Connor, while at MSKCC. Dr. O'Connor and his colleagues identified the unique activity of pralatrexate in patients with lymphoma. Dr. O'Connor has continued to study pralatrexate at NewYork-Presbyterian/Columbia, now focusing on determining how the drug works in T-cell lymphoma, and on how best to combine it with other drugs to improve the treatment of patient with hematologic cancers.

New York- Presbyterian Hospital/Weill Cornell Medical Center/Weill Cornell Medical College

Pralatrexate approved for peripheral T-Cell lymphoma.(NEWS FROM THE FDA): An article from: Family Practice News
by Elizabeth Mechcatie (Author)

This digital document is an article from Family Practice News, published by International Medical News Group on October 15, 2009. The length of the article is 465 words. The page length shown above is based on a typical 300-word page. The article is delivered in HTML format and is available immediately after purchase. You can view it with any web browser.

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Title: Pralatrexate approved for peripheral T-Cell lymphoma.(NEWS FROM THE FDA)
Author: Elizabeth Mechcatie
Publication: Family Practice News (Magazine/Journal)
Date: October 15, 2009
Publisher: International Medical News Group
Volume: 39 Issue: 18 Page: 5(1)

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FDA approves pralatrexate for treatment of peripheral T-cell lymphoma.: An article from: BIOTECH Patent News
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This digital document is an article from BIOTECH Patent News, published by Biotech Patent News on August 1, 2009. The length of the article is 1021 words. The page length shown above is based on a typical 300-word page. The article is delivered in HTML format and is available immediately after purchase. You can view it with any web browser.

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Publication: BIOTECH Patent News (Newsletter)
Date: August 1, 2009
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Volume: 23 Issue: 8 Page: NA

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Pralatrexate
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Pralatrexate
by Ronald Cohn Jesse Russell (Author)

High Quality Content by WIKIPEDIA articles! Pralatrexate (brand name Folotyn) is an anti-cancer therapy. It is the first drug approved as a treatment for patients with relapsed or refractory peripheral T-cell lymphoma, or PTCL - a biologically diverse group of aggressive blood cancers that have a poor prognosis. This book was created using print-on-demand technology.

New analysis demonstrates activity in relapsed or refractory transformed mycosis fungoides.(PIPELINE PREVIEWS): An article from: Journal of Drugs in Dermatology
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This digital document is an article from Journal of Drugs in Dermatology, published by Journal of Drugs in Dermatology, Inc. on February 1, 2011. The length of the article is 555 words. The page length shown above is based on a typical 300-word page. The article is delivered in HTML format and is available immediately after purchase. You can view it with any web browser.

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Title: New analysis demonstrates activity in relapsed or refractory transformed mycosis fungoides.(PIPELINE PREVIEWS)
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Date: February 1, 2011
Publisher: Journal of Drugs in Dermatology, Inc.
Volume: 10 Issue: 2 Page: 213(2)

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Physician's Cancer Chemotherapy Drug Manual 2011 (Jones & Bartlett Learning Oncology)
by Edward Chu (Author), Vincent T. DeVita Jr. (Author)

Completely revised and updated for 2011, the Physicians Cancer Chemotherapy Drug Manual 2011 is an up-to-date guide to the latest information on standard therapy and recent advances in the field. Written by world-class experts in clinical cancer therapeutics, this essential reference provides a complete, easy-to-use catalogue of over 100 drugs and commonly used drug regimens both on- and off-label for the treatment of all the major cancers. Special Features Include: Revised to reflect rapid advances in the field, incorporating treatment strategie and new drugs like Cabazitaxel, Ofatumumab, Pazopanib, and Pralatrexate. A specific chapter focused on profiling antiemetic drug and antiemetic treatment regimens. Diagrams of drug structures and pathways for each agent. Offers a comprehensive...