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Campath

Alemtuzumab (marketed as Campath or Campath-1H) is a monoclonal antibody used in the treatment of chronic lymphocytic leukemia (CLL) and T-cell lymphoma. more...

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Alemtuzumab targets CD52, a protein present on the surface of mature lymphocytes, but not on the stem cells from which these lymphocytes were derived. It is used as second line therapy for CLL. It was approved by the FDA for patients who have been treated with alkylating agents and who have failed fludarabine therapy.

A significant complication of therapy with alemtuzumab is that it significantly increses the risk for opportunistic infections, in particular, reactivation of cytomegalovirus.

Alemtuzumab is also used in some conditioning regimens for bone marrow transplantation.

History

The origins of alemtuzumab date back to Campath-1 which was derived from the mouse antibodies raised against human lymphocyte proteins (Hale et al 1983). The name "Campath" derives from the pathology department of Cambridge University. Initially, Campath-1 was unsuitable for therapy because patients reacted against the foreign mouse protein of the antibody. To circumvent this problem, Greg Winter and his colleagues humanised Campath-1, by extracting the hypervariable loops that had specificity for CD52 and grafted it onto a human antibody framework. This became known as Campath-1H and serves as the basis for alemtuzumab (Riechmann et al 1988).

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ANTIBODIES: Biologics License Filed for Campath - monoclonal antibody for treatment of b-cell chronic lymphocytic leukemia - Brief Article
From Applied Genetics News, 1/1/00

ILEX Oncology, Inc. (11550 Hwy. 10 W., Suite 100, San Antonio, TX 78230; Tel: 210/949-8200, Fax: 210/949-8210; Website: ilexoncology.com) and Millennium Pharmaceuticals, Inc. (640 Memorial Dr., Cambridge, MA 02139; Tel: 617/679-7000, Fax: 617/374-9379; Website: mlnm.com) have submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration for CAMPATH (alemtuzumab), a humanized monoclonal antibody, for the treatment of b-cell chronic lymphocytic leukemia (CLL) refractory to existing therapies.

CLL, the most prevalent form of adult leukemia, is characterized by an accumulation of malignant lymphocytes in the bone marrow and other tissues, causing bone marrow dysfunction and enlargement of the lymph nodes, liver, and spleen.

CAMPATH has received "Fast Track" designation from the FDA and is expected to undergo a six-month priority review, which begins with the submission of a BLA.

ILEX Oncology and LeukoSite entered into a distribution and development agreement with Schering AG in August 1999. The agreement grants Schering AG exclusive marketing and distribution rights to CAMPATH in the U.S., Europe, and the rest of the world, except Japan and East Asia. At the same time, Berlex Laboratories, Inc. (Montville, NJ) obtained exclusive U.S. distribution and marketing rights for CAMPATH from LeukoSite and ILEX.

Millennium acquired LeukoSite in December 1999, and thus an interest in CAMPATH.

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