Rovelizumab
Encyclopedia
Rovelizumab, also known as LeukArrest and Hu23F2G, is a humanize
d monoclonal antibody which was an experimental immunosuppressive drug
. Rovelizumab was developed by Icos
to treat patients suffering from haemorrhagic shock. The drug is a monoclonal antibody that suppresses white blood cell
s which become overly active during shock. During testing the number of patients given the drug was low because rovelizumab had to be delivered within four hours of the injury and consent
was required. Often the patient was unconscious and relatives had to be reached to give consent. In June 1998, Icos and many medical centers asked the United States Food and Drug Administration
(FDA) to waive consent requirements in situations where the patient was at high risk of dying and relatives could not be reached. While some medical ethicists opposed waiving consent, the FDA approved the proposal in August 1998 for five medical centers. Development of rovelizumab was halted in April 2000 when interim data from phase III clinical trials did not meet Icos's goals. The company's goals for rovelizumab included reducing the chance of multiple organ failure and reducing the death-rate from shock at 28 days. Rovelizumab was also being tested for treating heart attack, multiple sclerosis
, and stroke
, and was being explored as a treatment for cerebral vasospasm, head trauma, kidney transplantation
, and restenosis
.
Multiple companies have tried to develop anti-CD18
drugs, but none of them have been successful. Among them are Genentech
's erlizumab
, and two drugs developed by Protein Design Labs (PDL) and Centocor
. Although trials in humans have not gone well, the research of anti-CD18 drugs in animals has been encouraging. It is thought that the experimental medicines are affecting the lymphocyte adhesion pathway in humans in unintended ways.
Humanize
Humanize may refer to:*Humanize a 2001 album by the British jazz/funk band Big Boss Man*Humanized antibody, a type of monoclonal antibody...
d monoclonal antibody which was an experimental immunosuppressive drug
Immunosuppressive drug
Immunosuppressive drugs or immunosuppressive agents are drugs that inhibit or prevent activity of the immune system. They are used in immunosuppressive therapy to:...
. Rovelizumab was developed by Icos
ICOS
Icos Corporation was the largest biotechnology company in the U.S. state of Washington before it was sold to Eli Lilly and Company in 2007. Co-founded in 1989 by George B. Rathmann, a pioneer in the industry and Chief Executive Officer and co-founder of Amgen, Icos focused on the development of...
to treat patients suffering from haemorrhagic shock. The drug is a monoclonal antibody that suppresses white blood cell
White blood cell
White blood cells, or leukocytes , are cells of the immune system involved in defending the body against both infectious disease and foreign materials. Five different and diverse types of leukocytes exist, but they are all produced and derived from a multipotent cell in the bone marrow known as a...
s which become overly active during shock. During testing the number of patients given the drug was low because rovelizumab had to be delivered within four hours of the injury and consent
Informed consent
Informed consent is a phrase often used in law to indicate that the consent a person gives meets certain minimum standards. As a literal matter, in the absence of fraud, it is redundant. An informed consent can be said to have been given based upon a clear appreciation and understanding of the...
was required. Often the patient was unconscious and relatives had to be reached to give consent. In June 1998, Icos and many medical centers asked the United States Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
(FDA) to waive consent requirements in situations where the patient was at high risk of dying and relatives could not be reached. While some medical ethicists opposed waiving consent, the FDA approved the proposal in August 1998 for five medical centers. Development of rovelizumab was halted in April 2000 when interim data from phase III clinical trials did not meet Icos's goals. The company's goals for rovelizumab included reducing the chance of multiple organ failure and reducing the death-rate from shock at 28 days. Rovelizumab was also being tested for treating heart attack, multiple sclerosis
Multiple sclerosis
Multiple sclerosis is an inflammatory disease in which the fatty myelin sheaths around the axons of the brain and spinal cord are damaged, leading to demyelination and scarring as well as a broad spectrum of signs and symptoms...
, and stroke
Stroke
A stroke, previously known medically as a cerebrovascular accident , is the rapidly developing loss of brain function due to disturbance in the blood supply to the brain. This can be due to ischemia caused by blockage , or a hemorrhage...
, and was being explored as a treatment for cerebral vasospasm, head trauma, kidney transplantation
Kidney transplantation
Kidney transplantation or renal transplantation is the organ transplant of a kidney into a patient with end-stage renal disease. Kidney transplantation is typically classified as deceased-donor or living-donor transplantation depending on the source of the donor organ...
, and restenosis
Restenosis
Restenosis literally means the reoccurrence of stenosis, a narrowing of a blood vessel, leading to restricted blood flow. Restenosis usually pertains to an artery or other large blood vessel that has become narrowed, received treatment to clear the blockage and subsequently become renarrowed...
.
Multiple companies have tried to develop anti-CD18
CD18
Integrin beta-2 is a protein that in humans is encoded by the ITGB2 gene.It is the beta subunit of four different structures:* LFA-1 * Macrophage-1 antigen * Integrin alphaXbeta2...
drugs, but none of them have been successful. Among them are Genentech
Genentech
Genentech Inc., or Genetic Engineering Technology, Inc., is a biotechnology corporation, founded in 1976 by venture capitalist Robert A. Swanson and biochemist Dr. Herbert Boyer. Trailing the founding of Cetus by five years, it was an important step in the evolution of the biotechnology industry...
's erlizumab
Erlizumab
Erlizumab, also known as rhuMAb, is a recombinant humanized monoclonal antibody that was an experimental immunosuppressive drug. Erlizumab was developed by Genentech under a partnership with Roche to treat heart attack, stroke, and traumatic shock....
, and two drugs developed by Protein Design Labs (PDL) and Centocor
Centocor
Janssen Biotech, Inc., formerly Centocor Biotech, Inc., is a biotechnology company that was founded in Philadelphia in 1979 with an initial goal of developing new diagnostic assays using monoclonal antibody technology....
. Although trials in humans have not gone well, the research of anti-CD18 drugs in animals has been encouraging. It is thought that the experimental medicines are affecting the lymphocyte adhesion pathway in humans in unintended ways.