Samaritan Pharmaceuticals has announced that it has filed an IND (Investigational New Drug) application for SP-6310 in the treatment of HIV-infected patients with abnormal cortisol levels.
Following discussions and protocol agreement with U.S. Food and Drug Administration (FDA), Samaritan will conduct an 8-week Phase II clinical study with SP-6310 in HIV-infected patients with abnormal cortisol levels while on antiretroviral therapy. Samaritan expects that the results of this study will confirm the positive results found in a previously conducted Phase I/II.
It has been hypothesized that HIV-associated disregulation of cortisol may play a role in the pathophysiology of AIDS, including modulation of cell-mediated immunity. Experimental evidence suggests that cortisol and its receptors are critically involved at some level in the regulation of immune function in HIV infection. Abnormal levels of cortisol and DHEA (Dehydroepiandrosterone) may switch the predominant immune response to HIV from TH1 to TH2 type responses and may be immunosuppressive as well. Therefore, treatment with a cortisol-modulating agent may improve immune function as well as quality of life in HIV-infected patients. Clinical study data shows that SP-6310, given orally, modulates cortisol levels in HIV-infected patients and, therefore, represents a potential therapy for the normalization of both low and high urinary cortisol levels in HIV-infected patients while on antiretroviral therapy.
Dr. Janet Greeson, Chief Executive Officer of Samaritan commented, “SP-6310 was born out of Samaritan’s intrinsic desire to bring significantly beneficial, affordable, first- and second-line treatment regimens to all suffering HIV patients, including those in the developing world. We believe SP-6310 has robust promise to do so.”