TREANDA New Drug Application For The Treatment Of Chronic Lymphocytic Leukemia Granted Priority Review Status By FDA

FRAZER, Pa. -- Cephalon, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review designation to the TREANDA(R) (bendamustine HCl) New Drug Application (NDA) for the first-line treatment of patients with chronic lymphocytic leukemia (CLL). CLL is a slowly progressing blood and bone marrow disease with an estimated 15,000 new cases diagnosed every year in the United States. Cephalon filed the TREANDA NDA for CLL in September 2007 and the FDA will make a review decision by the end of March 2008. "If approved, TREANDA will make a meaningful difference as the first new CLL treatment option approved by the FDA since 2001 and could be available as soon as the second quarter... More »


New Drugs Offer Hope In Treatment Of Blood Cancer

MILWAUKEE -- A better understanding of plasma cells and how they act inside bone marrow has enabled scientists to improve dramatically treatment of patients with the blood cancer multiple myeloma. In the past decade, they've tweaked old drugs and created new ones to either slow or stabilize tumor growth. As a result, patients now live longer and doctors have become increasingly hopeful that the often fatal and incurable disease soon will be treated more like a chronic condition. "It's like night and day," said Mitchell Smith, director of the lymphoma service at Fox Chase Cancer Center in Philadelphia, who's been treating patients with multiple myeloma for almost 20 years. "When I started practicing, you'd tell patients they'd ha... More »


Vion Pharmaceuticals Announces Initiation Of Clinical Trial Of Cloretazine In Combination With Stem Cell Transplantation

NEW HAVEN, Conn. -- VION PHARMACEUTICALS, INC. today announced the start of an investigator-sponsored Phase I clinical trial of its lead anticancer agent Cloretazine(R) (VNP40101M) in combination with hematopoietic cell transplant (HCT) in patients with various advanced hematologic malignancies. The trial is being conducted under the direction of Roy Jones, M.D., Ph.D., a professor in the Department of Stem Cell Transplantation at The University of Texas M.D. Anderson Cancer Center. The objective of the trial is to define the maximum tolerated dose (MTD) of Cloretazine(R) (VNP40101M) when given to patients of 18 to 65 years of age with poor-prognosis leukemia, lymphoma, and Hodgkin's disease who are undergoing either... More »


National Cancer Institute Study To Determine The Optimal Time For CLL Patients To Begin Treatment

WESTBOROUGH, Mass. -- Genzyme Genetics, a business unit of Genzyme Corporation, announced today its participation in a Cancer and Leukemia Group B (CALGB) study sponsored by the National Cancer Institute. The multi-center study will include 1,700 newly diagnosed patients with chronic lymphocytic leukemia (CLL) and is designed to test the hypothesis that early treatment of patients with certain negative risk factors leads to longer survival. Genzyme will perform the IgVH mutation analysis for the study. "This study is critical in helping us to understand the natural history of CLL with respect to early versus delayed progression," said John Byrd, director of hematologic malignancies & co-director, Division of Hematology-... More »


Clinical Studies Of OvaRex In Advanced Ovarian Cancer Fail To Meet Primary Endpoint

SILVER SPRING, Md. and WELLESLEY HILLS, Mass. -- United Therapeutics Corporation and its wholly- owned subsidiary, Unither Pharmaceuticals, Inc., announced today the completion of their two pivotal trials of OvaRex(R) MAb for the treatment of advanced ovarian cancer. Preliminary analysis demonstrates that the studies failed to reach statistical significance. The identical studies, known as IMPACT I and II (IMunotherapy Pivotal ovArian Cancer Trial), were randomized, double-blind, placebo-controlled trials conducted at over 60 centers across the United States. The studies enrolled 367 ovarian cancer patients and assessed the efficacy of OvaRex mono- immunotherapy during the so-called "watchful waiting" period following fro... More »