Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Celgene-CELG -- Ignore unavailable to you. Want to Upgrade?

To: Mike K who wrote (551)	7/9/2001 9:03:35 AM
From: nigel bates	Read Replies (2) \| Respond to of 804

WARREN, N.J., July 9 /PRNewswire/ -- Celgene Corporation (Nasdaq: CELG - news) -- A study titled ``Extended Survival in Advanced and Refractory Multiple Myeloma After Single-agent Thalidomide: Identification of Prognostic Factors in a Phase II Study of 169 Patients'' published in the July 15th issue of Blood reports two-year event-free and overall survival rates of 20 percent and 48 percent respectively in a follow up of a phase II trial of 169 advanced and refractory multiple myeloma patients given THALOMID® (thalidomide) as a single-agent treatment. Additionally, the trial's principal investigator, Bart Barlogie, M.D., Ph.D., and researchers at the Arkansas Cancer Research Center found higher response rates (63 percent vs. 45 percent) and longer survival time (54 percent vs. 21 percent) in patients who received higher dosing (greater than or equal to 42 grams) of THALOMID in a three month period. ``This is an important study investigating survival rates in advanced and refractory multiple myeloma patients treated with thalidomide as a monotherapy,'' said Dr. Barlogie. The phase II study was initiated to evaluate the use of THALOMID in multiple myeloma patients who relapsed after high dose chemotherapy. Patients received a starting dose of 200mg/day escalated by 200mg/day every two weeks to 800mg/day according to tolerance. THALOMID was escalated to 400mg, 600mg and 800mg in 87 percent, 68 percent and 56 percent of patients respectively. Of the study's 169 patients, 37 percent demonstrated a greater than or equal to 25 percent reduction in myeloma protein, 30 percent demonstrated a greater than or equal to 50 percent reduction and 14 percent of patients achieved a complete or near complete response. Two-year event-free survival and overall survival rates were measured at a median of 22 months among 84 patients. This study extends results of 84 patients previously reported in The New England Journal of Medicine (November 1999). ``We are pursuing additional clinical trials of THALOMID as both a single- agent and in combination therapy for advanced and early stage multiple myeloma,'' said Sol J. Barer, Ph.D., President and Chief Operating Officer of Celgene Corporation. The study's most commonly reported side effects included one or more grade greater than or equal to 3 toxicities. Twenty-five percent of patients experienced events affecting the central nervous system, such as sedation and somnolence; confusion, depression and tremor. Sixteen percent of patients experienced gastrointestinal toxicities, mainly constipation. Neuropathy was seen in 9 percent of patients. Less than two percent of patients developed deep vein thrombosis. These toxicities were found to be dose related. About Multiple Myeloma There are approximately 40,000 to 50,000 people in the United States living with multiple myeloma and 14,000 new cases of multiple myeloma are diagnosed each year in the United States, making it the second most common blood cancer. Incurable with conventional chemotherapy, multiple myeloma is a malignant cancer of the plasma cell, which is a type of white blood cell found in many tissues of the body, but mainly in the bone marrow. As the cancer grows it destroys normal bone tissue, causing pain and crowding out normal cell production. There are nearly 11,200 deaths expected during 2001, according to the American Cancer Society. Safety Notice 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. To minimize this risk, only prescribers and pharmacies registered with the System for Thalidomide Education and Prescribing Safety (S.T.E.P.S(TM)) distribution program may prescribe or dispense THALOMID® (thalidomide). Other adverse drug reactions known to be associated with thalidomide therapy include: peripheral neuropathy, a common, potentially severe side effect that may be irreversible; drowsiness/somnolence; dizziness/orthostatic hypotension; neutropenia; hypersensitivity reactions; and increased HIV-viral load. Physicians should consult full prescribing information about these and other adverse reactions prior to initiating treatment with THALOMID®.