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Small molecule and peptide therapy to elevate CD4 counts. Two large patient populations with low CD4 counts, HIV/AIDS and cancer, stand to benefit from α1PI peptide or small molecule 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 peptides or small molecules 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 peptides or small molecules to elevate CD4 counts will 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.

The primary cause of low CD4 counts in cancer is cancer therapy whereas the primary cause of low CD4 counts in HIV/AIDS is the inactivation and deficiency of α1PI which is necessary for regulating CD4 counts. In both cases, CD4 counts can be elevated using small molecules as a substitute for α1PI. In HIV/AIDS, an additional approach possible.

The primary cause of α1PI deficiency in HIV-1 infected individuals is the inadvertent binding of anti-HIV antibodies to α1PI 7. Dr. Bristow has identified the specific antibody responsible for this activity, and this information led to the identification of the precise region within α1PI that is bound by the antibody. Reproducing this region of α1PI as a peptide can be accomplished in a manner similar to producing insulin.

The strategy of using such a peptide is that it can bind to the antibody thereby preventing the antibody from binding to the bodyís natural α1PI. In this manner the bodyís natural resource of α1PI is liberated and available for upregulating CD4 counts. Producing α1PI peptides is considerably less costly than producing recombinant α1PI. Further, peptides can be injected whereas recombinant α1PI requires infusion over a period of approximately 30 min.

Small molecules have been developed that have the potential to act as a substitute for α1PI in its role to elevate CD4 counts. Whereas α1PI peptides can be used only in HIV disease, small molecules have the potential to be effective in HIV/AIDS and in pre- and post-cancer therapy.

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