alexa Preclinical and First-In-Human Phase I Clinical Evaluation of Stampidine, a Potent Anti-HIV Pharmaceutical Drug Candidate
ISSN 2155-6113

Journal of AIDS & Clinical Research
Open Access

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Research Article

Preclinical and First-In-Human Phase I Clinical Evaluation of Stampidine, a Potent Anti-HIV Pharmaceutical Drug Candidate

Pedro Cahn1,2,3*, Maria Jose Rolon2, Ana Mirta Gun2, Ines Ferrari4, Ilker Dibirdik5,6, Sanjive Qazi5,6, Osmond D'Cruz5,6,8, Kazim Sahin7 and Fatih Uckun6,8,9*

1Department of Medicine, Buenos Aires University Medical School, Buenos Aires, Argentina

2Infectious Diseases Unit, Hospital Juan A. Fernández, Buenos Aires, Argentina

3Fundación Huesped,m Buenos Aires, Argentina

4Laboratorio de Bioequivalencia y Biologia Molecular, Universidad Barceló. French 2464 – Ciudad Autonoma de Buenos Aires, Argentina

5Paradigm Pharmaceuticals, St. Paul, Minnesota 55455, Drug Discovery Program, USA

6Parker Hughes Institute, St. Paul, MN 55455, USA

7Faculty of Veterinary Science and Department of Nutrition, Firat University, Elazig, Turkey

8Developmental Therapeutics Program, Children’s Hospital Los Angeles, Children’s Center for Cancer and Blood Diseases, Los Angeles, CA 90027, USA

9Department of Pediatrics, University of Southern California Keck School of Medicine, Los Angeles, CA 90027, USA

*Corresponding Author:
Fatih M. Uckun, M.D., Ph.D.,
Children’s Center for Cancer and Blood Diseases
Children’s Hospital Los Angeles, MS#57, Los Angeles
California 90027-0367, USA
Tel: (323)-361-4328
Fax: 323-361-876
E-mail: [email protected]

Pedro Cahn, M.D, Ph.D.,
Fundación Huesped
Angel Peluffo 3932 (C1202ABB) Buenos Aires, Argentina
E-mail: [email protected]

Received Date: December 22, 2011; Accepted Date: January 20, 2012; Published Date: January 24, 2012

Citation: Cahn P, Rolon MJ, Gun AM, Ferrari I, Dibirdik I, et al. (2012) Preclinical and First-In-Human Phase I Clinical Evaluation of Stampidine, a Potent Anti-HIV. J AIDS Clinic Res 3:138. doi:10.4172/2155-6113.1000138

Copyright: © 2012 Cahn P, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

 

Abstract

The rationally designed novel anti-HIV drug candidate Stampidine exhibited (a) remarkable subnanomolar to low nanomolar in vitro ARV potency against genotypically and phenotypically NRTI-resistant primary clinical HIV isolates, non-nucleoside reverse transcriptase inhibitor (NNRTI)-resistant HIV-1 isolates, clinical non-B subtype HIV- 1 isolates (subtypes A, C, F, and G) originating from South America, Asia, and sub-Saharan Africa with resistance to stavudine, adefovir and tenofovir, as well as recombinant HIV clones containing common patterns of RT mutations responsible for NRTI resistance such as multiple TAMs plus M184V, multiple TAMs plus T69 insertion, and Q151 complex (b) favorable, safety profile in mice, rats, dogs, and cats, and (c) promising prophylactic in vivo anti-retroviral activity in Hu-PBL-SCID mice as well as therapeutic anti-retroviral activity in FIV-infected domestic cats. Notably, in a placebo-controlled Phase I study involving 30 therapy-naïve adult HIV-infected adult patients, formulated GMP- grade oral Stampidine capsules did not cause dose-limiting toxicity at single dose levels ranging from 5 to 25 mg/kg. Taken together, the presented favorable preclinical and early clinical safety/activity profile of Stampidine warrants its further development as a new anti-HIV drug candidate.

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