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Leukemia cases raise questions

By KAREN TOLKKINEN
Staff Reporter
February 17, 2005 - Since 2001, at least six children from Daphne, Fairhope and Point Clear have been diagnosed with leukemia. Two have died. While the number of known cases nearly matches the national rate of 4.2 cases per 100,000 residents diagnosed each year, parents of those children and several adults who are also fighting leukemia said they wonder if something unique is happening in their communities.

On Feb. 22, those families are scheduled to meet with state toxicologist Neil Sass, who is studying the matter, and well-known environmental activist Wilma Subra of Louisiana, who said the cases seem concentrated enough within those communities that they could signal something gone awry in the environment.

The Alabama Cancer Registry said Baldwin County's numbers from 1996 to 2002, the most recent data available, showed no fluctuation in the number of childhood leukemia diagnoses.

"It's right in line with what the expected case rate would be," registry project manager Vickie Nelson said. "That's what the numbers are telling us right now. Everything looks OK." Still, parents said, they're worried about possible environmental connections.

"For some time now, several of us have noticed that there simply seems to be too many of us in the Fairhope area diagnosed with leukemia and lymphoma," Lesley and Chris Pacey, parents of a 4-year-old girl who was diagnosed with leukemia in July, wrote in a Feb. 8 letter to patients and their families inviting them to the meeting.

Lesley Pacey is a Mobile Register correspondent.

Whether there are "too many" diagnosed with blood cancer is in question. Lesley Pacey has assembled a list of 12 names of leukemia and lymphoma victims from the three communities, but two had just moved to the area when they were diagnosed, one had died a decade earlier and another was diagnosed in the 1990s.

Alabama's cancer registry does not release numbers from individual communities when they are small enough to jeopardize patient confidentiality, Nelson said. The state compiles data a year behind and is working on 2003 figures now, she said.

Sass said he plans to meet with two Fairhope pediatricians before next week's meeting. It's part of Sass' job to travel to communities that have health concerns.

"Depending on the type of leukemia, we might be able to trace it back to a causative agent, some kind of exposure," he said.

He cautioned against unwarranted alarm. Potential causes must not be widespread, he believes, or there would be more cases.

Pacey said she hopes that the meeting will uncover other cases if they exist.

Leukemia is a cancer of the blood and bone marrow.

The only factors that scientists have linked to leukemia are chronic workplace exposure to the chemical benzene and exposure to extraordinary doses of radiation, according to the White Plains, N.Y.-based Leukemia and Lymphoma Society, which funds research. Benzene is produced naturally by volcanoes and forest fires. It's also found in cigarette smoke, gas stations, industrial emissions, car exhaust and glues, paint, furniture wax and detergent, according to the federal Agency for Toxic Substances and Disease Registry.

The M.D. Anderson Cancer Center at the University of Texas says that there may be a genetic predisposition to the disease, and those with immune system deficiencies may also be more at risk.

Fairhope veterinarian Teresa Marshall, diagnosed with leukemia in 2002, said she is aware of others who have leukemia, and that she plans to attend next week's meeting.

"It'll be interesting to see if there's a pattern," she said.

REVLIMID(R) New Drug Application Submitted to FDA for Review

Clinical Data From Phase II Trial (MDS-003) in Patients With Myelodysplastic Syndromes With 5q Deletion Chromosomal Abnormality Submitted

SUMMIT, N.J., April 8 /PRNewswire-FirstCall/ -- Celgene Corporation (Nasdaq: CELG) announced that it has completed the rolling submission of its New Drug Application (NDA) for REVLIMID (lenalidomide), an investigational drug, to the Division of Oncology Drug Products at the U.S. Food and Drug Administration (FDA) for review. The Company's NDA is seeking approval to market REVLIMID as a treatment for transfusion-dependent patients with myelodysplastic syndromes (MDS) with a 5q deletion chromosomal abnormality.

MDS is a malignant disorder of blood cell production that affects approximately 300,000 people worldwide. The most common clinical manifestation associated with MDS is refractory anemia, and the multiple complications that stem from frequent blood transfusions. Celgene's lead IMiD(R) (Immunomodulatory drug), REVLIMID has received both orphan drug status and fast track designation from the U.S. Food and Drug Administration (FDA) and orphan drug status from the European Agency for the Evaluation of Medicinal Products for the treatment of MDS.

"Celgene appreciates and acknowledges the efforts of all those who made this filing possible, including: the more than 400 patients who participated in these MDS studies, and the international community of clinical investigators who have helped us get to this stage in the regulatory process." said Jerome B. Zeldis, M.D., Ph.D., Chief Medical Officer and VP, Medical Affairs of Celgene Corporation.

About REVLIMID(R)

REVLIMID is a member of a new class of novel immunomodulatory drugs, or IMiDs(R). Celgene is evaluating treatments with REVLIMID for a broad range of hematology and oncology conditions, including; multiple myeloma, the malignant blood cell disorders known as myelodysplastic syndromes (MDS) as well as solid tumor cancers. REVLIMID affects multiple intracellular biological pathways. The IMiD pipeline, including REVLIMID, is covered by a comprehensive intellectual property estate of U.S. and foreign issued and pending patent applications including composition-of-matter and use patents.

REVLIMID(R) (lenalidomide) is not approved by the FDA or any other regulatory agencies as a treatment in any indication and is currently being evaluated in clinical trials for efficacy and safety for future regulatory applications.

About Myelodysplastic Syndromes

Myelodysplastic syndromes (MDS) are a group of hematologic malignancies that affect approximately 300,000 people worldwide. Myelodysplastic syndromes occur when blood cells remain in an immature or "blast" stage within the bone marrow and never develop into mature cells capable of performing their necessary functions. Eventually, the bone marrow may be filled with blast cells suppressing normal cell development. According to the American Cancer Society, 10,000 to 20,000 new cases of MDS are diagnosed each year in the United States, with mean survival rates ranging from approximately six months to six years for the different classifications of MDS. MDS patients must often rely on blood transfusions to manage symptoms of anemia and fatigue until they develop life-threatening iron overload and/or toxicity, thus underscoring the critical need for new therapies targeting the cause of the condition rather than simply managing its symptoms.

About 5q Deletion Chromosomal Abnormality

Chromosomal (cytogenetic) abnormalities are detected in more than half of patients with myelodysplastic syndrome (MDS), and involve a deletion in all or part of one or more specific chromosomes. The most common cytogenetic abnormalities in MDS are deletions in the long arm of chromosomes 5, 7, and 20. Another common abnormality is an extra copy of chromosome 8. A deletion involving the 5q chromosome may be involved in 20 to 30% of all MDS patients. The World Health Organization has also recently identified a unique subset of MDS patients with a "5q- Syndrome" where the only chromosomal abnormality is a specific portion of the 5q chromosome.

About Celgene

Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company's website at http://www.celgene.com .

This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company's control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company's filings with the Securities and Exchange Commission such as 10K, 10Q and 8K reports.

CONTACT:
Robert J. Hugin
Senior VP and CFO
+1-908-673-9102

Brian P. Gill
Director PR-IR
Celgene Corporation
+1-908-673-9530

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