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Therapy for elevating CD4 counts. Bristow discovered that the blood protein α1PI regulates CD4 counts and that the mechanism for regulation involves cell motility. In clinical situations where CD4 counts are excessively low, treatment with α1PI can be used to elevate CD4 counts. States of immunodeficiency in which CD4 counts are excessively low include HIV/AIDS, post-cancer therapy, and liver failure.

Two large patient populations with low CD4 counts, HIV/AIDS and cancer, stand to benefit from α1PI therapy. Globally, there are 34 million HIV infected individuals and in the US, 1.2 million. Globally, there were 7 million deaths due to cancer in 2008. With 12 million cancer patients in the US and 763,000 deaths due to cancer in 2008, the prevalence of cancer is 10-fold greater than HIV/AIDS.

Treating HIV/AIDS patients with α1PI to elevate CD4 counts has the potential to have a major impact on the HIV epidemic. CD4 cells are necessary for the bodyís natural defenses against infection. By elevating CD4 counts in HIV/AIDS, the body regains the ability to fight infection thereby providing a major impact on the cost and health outcomes of HIV/AIDS patients.

Treating cancer patients with α1PI to elevate CD4 counts has the potential to have a major impact on the cost and health outcomes of patients. Cancer therapy often involves chemotherapy and radiation therapy which generally affect cells that divide rapidly. These treatments kill rapidly dividing cells, and cancer cells divide more often than most healthy cells. However, because bone marrow cells also divide frequently, high-dose treatments can severely damage or destroy the patientís bone marrow. Without healthy bone marrow, the patient is no longer able to make the CD4 cells needed to fight infection. The current strategy for avoiding the bad aftereffects of cancer therapy is to harvest stem cells from a patient prior to cancer therapy and then to give the patientís cells back after therapy to re-establish healthy bone marrow.

With collaborators at CSL Behring, Dr. Bristow showed in a successful clinical trial that CD4 T cells increased to normal levels in HIV and non-HIV patients within 2 weeks of initiating α1PI augmentation therapy treatment unlike anything that has ever been observed previously. Unlike all other attempts to increase CD4 T cells, because α1PI is the natural regulator of CD4 counts, there were no adverse effects of treatment. A second confirmatory clinical trial with Grifols Biotherapeutics is currently in progress, and preliminary results will be available in December, 2012.

Bristow, C.L., Cortes, J., Mukhtarzad R., Trucy, M., Franklin, A., Romberg, V., Winston, R. 2010. a1Antitrypsin therapy increases CD4+ lymphocytes to normal values in HIV-1 patients. In Soluble Factors Mediating Innate Immune Responses to HIV Infection, (ed. M. Alfano). Bentham Science Publishers, http://www.eurekaselect.com/54309/volume/1







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