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news.Samaritan Pharmaceuticals has filed an investigational new drug application for SP-6310 in the treatment of HIV-infected patients with abnormal cortisol levels.
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Following discussions and protocol agreement with the FDA, Samaritan will conduct an eight-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.
Janet Greeson, CEO of Samaritan, said: “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.”