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Biotech / Medical : Celgene-CELG
CELG 108.240.0%Nov 22 4:00 PM EST

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To: Miljenko Zuanic who wrote (306)5/17/1999 11:29:00 PM
From: Biomaven  Read Replies (1) of 804
 
Here's some ASCO news. Should also get some Crohn's news later this week.

Peter

ASCO Abstracts Report Thalidomide Results in Glioblastoma Patients and Quality of Life in Advanced Cancer Patients
THALOMID(R) Tested in Pilot Studies at New York University and University of Alberta
ATLANTA, May 17 /PRNewswire/ -- Two teams of researchers nvestigating the use of THALOMID® (thalidomide)announced that the drug has activity in recurrent glioblastoma multiforme (GBM), and that quality of life measures improved in patients with advanced cancers. These findings were announced this past weekend at two separate presentations here as part of the 35th Annual Meeting of the American Society of Clinical Oncology (ASCO).
GLIOBLASTOME MULTIFORME
Jon Glass, MD, from New York University Medical Center, presented phase I/II data on thalidomide used in combination with Paraplatin® (carboplatin) to assess the safety and efficacy of this combination therapy in treating patients with recurrent
GBM. The study of 71 patients determined the combination of THALOMID® (thalidomide) and carboplatin to be active in
recurrent GBM. Of the 45 patients who were evaluated for efficacy, 27% (12) had progressive disease and the rest either had stable disease or tumor regression. The most common side effects reported were constipation and drowsiness. GBM is a
highly malignant and usually fatal type of brain tumor that is diagnosed in approximately 9,000 individuals annually. The average survival time following diagnosis is six-to-twelve months.
CANCER/CACHEXIA/QUALITY OF LIFE
Sharon Watanabe, MD, lead investigator at Cross Cancer Institute at the University of Alberta, presented the results of a
phase I/II trial with THALOMID® (thalidomide). The drug was evaluated in terminal cancer patients using a quality of life
instrument.
The study measured the intensity of symptoms such as difficulty falling asleep, restedness in the morning, insomnia, nausea,
appetite and well-being in 18 patients before and after thalidomide treatment. After ten days of treatment, all quality of life measures improved by greater than 30 percent. At no time did any patient discontinue thalidomide treatment due to adverse
effects. According to Dr. Watanabe, the pilot study compares favorably to the results of other studies with agents currently
being used to improve quality of life for terminal cancer patients.
''We are very encouraged by these findings,'' said Sol Barer, Ph.D., president and chief operating officer of Celgene
Corporation. ''Both recurrent glioblastoma multiforme and other advanced cancer patients are therapeutically underserved
populations. It is our hope that THALOMID® will prove to be beneficial when integrated as part of the overall treatment for
these life- threatening conditions.''
Celgene Corporation received U.S. Food and Drug Administration (FDA) clearance to market and sell THALOMID®
(thalidomide) for the treatment of erythema nodosum leprosum (ENL) in leprosy, on July 16, 1998. The drug has been
commercially available since October 1, 1998. In December 1998, Celgene licensed from EntreMed, Inc. (Nasdaq: ENMD -news) the patented rights to thalidomide for use as an antiangiogenic agent. Recently, THALOMID® (thalidomide) received
orphan drug designation for multiple myeloma and Crohn's disease.
Thalidomide is contraindicated in pregnant women and women capable of becoming pregnant. Even a single capsule taken by
a pregnant woman can cause severe birth defects or death to an unborn baby.
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