Scientific publications 2007

Pragmatic and Principled: DNDi's Approach to IP Management by Banerji J and Pecoul B. Intellectual Property Management in Health and Agricultural Innovation: A Handbook of Best Practices (eds. A Krattiger, RT Mahoney, L Nelsen, et al.) 2007.
DNDi's mission is to develop safe, effective, and affordable new drugs for patients suffering from neglected diseases and to ensure equitable access to these drugs. DNDi believes that intellectual property (IP) rights should not pose a barrier to access to these medicines, and that a balanced approach to IP management is therefore critical. DNDi's IP policy articulates the organization’s approach to IP and ensures that products are accessible and affordable to patients who need them most. DNDi recognizes the reality of IP and seeks to implement its humanitarian mission using best, pragmatic practices for IP management. DNDi has already demonstrated that this is feasible, having successfully negotiated with both private and public sector institutions.
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Nifurtimox-Eflornithine Combination Therapy for Second-Stage Trypanosoma brucei gambiense Sleeping Sickness: A Randomized Clinical Trial in Congo by Priotto G, Kasparian S, Ngouama D, Ghorashian S, Arnold U, Ghabri S, Karunakara U. Clinical Infectious Diseases 2007 Dec; 45: 1435-1442.
Current treatment options for patients with second-stage disease are either highly toxic or impracticable in field conditions. The article compares the efficacy and safety of the nifurtimox-eflornithine drug combination with the standard eflornithine regimen for the treatment of second-stage disease. The nifurtimox-eflornithine combination appears to be a promising first-line therapy for second-stage sleeping sickness.
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Kala-Azar Outbreak in Libo Kemkem, Ethiopia: Epidemiologic and Parasitologic Assessment by Alvar J, Bashaye S, Argaw D, Cruz I, Aparicio P, Kassa A, Orfanos G, Parreno F, Babaniyi O, Gudeta N, Canavate C, Bern C. Am J Trop Med Hyg. 2007 Aug; 77(2): 275-82.
In May 2005, visceral leishmaniasis (VL) was recognized for the first time in Libo Kemkem, Ethiopia. In October 2005, a rapid assessment was conducted using data from 492 patients with VL treated in the district health center and a household survey of 584 residents of four villages. Local transmission resulted from multiple introductions, is now well established, and will be difficult to eradicate.
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Consultative meeting to develop a strategy for treatment of cutaneous leishmaniasis. Institut Pasteur, Paris, 13–15 June, 2006 by Modabber F, Buffet PA, Torreele E, Milon G, Croft SL. Kinetoplastid Biol Dis. 2007 Apr 24; 6:3.
A meeting was organized by Drugs for Neglected Diseases initiative (DNDi) and the Institute Pasteur (IP), Paris, to review the treatment for all forms of cutaneous leishmaniasis (CL) and to propose a strategy for the development of new efficacious and affordable treatments. Short and long-term objectives and activities were defined as a part of meeting recommendations.
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Topical buparvaquone formulations for the treatment of cutaneous leishmaniasis by Garnier T, Mantyla A, Jarvinen T, Lawrence MJ, Brown MB, Croft SL. J Pharm Pharmacol. 2007 Jan; 59(1):41-9.
As the part of a study to develop buparvaquone (BPQ) formulations for the treatment of cutaneous leishmaniasis, the topical delivery of BPQ and one of its prodrugs from a range of formulations was evaluated. The results confirm that BPQ and its prodrug 3-POM-BPQ can penetrate the skin from several formulations, making them potentially interesting candidates for further investigation of topical formulations using in-vivo models of cutaneous leishmaniasis.
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The Challenges of Chagas Disease - Grim Outlook or Glimmer of Hope? By Tarleton RL, Reithinger R, Urbina JA, Kitron U, Gürtler RE. Plos Med 2007 Dec; 4 (12): 1852-1857.
Despite estimates of up to 15 million existing cases and 50,000–200,000 new infections per year, funding for research, prevention, and control has been limited, and therapeutic options remain unsatisfactory. Consequently, several editorials and perspectives have recently drawn attention to Chagas disease and T. cruzi [8–10]. While these papers highlighted the impact of this disease on public health in the Americas, and rightly pointed out that major achievements have been made in its control, they failed to emphasize several key challenges that are currently undermining these achievements and that must be urgently addressed in order to move to the next stage: ensuring the long-term and sustainable control of this devastating disease.
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Efficacy and safety of artesunate plus amodiaquine in routine use for the treatment of uncomplicated malaria in Casamance, southern Senegal by Brasseur P, Agnamey P, Gaye O, Vaillant M, Taylor WR, Olliaro PL. Malar J. 2007 Nov 15; 6:150.
Artesunate plus amodiaquine (AS+AQ) was used to treat slide-proven Plasmodium falciparum-infected patients of all ages in the Oussouye district, Casamance, Senegal, over a period of six years (2000 to 2005). AS+AQ in combination was highly efficacious and well-tolerated in this area and justifies the decision to use it as first line treatment. Long-term monitoring of safety and efficacy should continue.
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An analytical method with a single extraction procedure and two separate high performance liquid chromatographic systems for the determination of artesunate, dihydroartemisinin and mefloquine in human plasma for application in clinical pharmacological studies of the drug combination by Lai CS, Nair NK, Mansor SM, Olliaro PL, Navaratnam V. J Chromatogr B Analyt Technol Biomed Life Sci. 2007 Oct 1; 857(2): 308-14.
The combination of two sensitive, selective and reproducible reversed phase liquid chromatographic (RP-HPLC) methods was developed for the determination of artesunate (AS), its active metabolite dihydroartemisinin (DHA) and mefloquine (MQ) in human plasma. The method was found to be suitable for use in clinical pharmacological studies.
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Artesunate – amodiaquine for the treatment of uncomplicated malaria by Sirima SB, Gansane A. Expert Opin Investig Drugs. 2007 Jul;16(7): 1079-85.
Without an effective vaccine for the prevention of malaria, a fundamental component of the strategy for the control of this disease is based on prompt and effective treatment. An important step is the recent registration in Morocco (the country where the drug is manufactured) of a fixed combination of artesunate plus amodiaquine by the Drugs for Neglected Diseases initiative with sanofi-aventis as the industrial partner.
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Antimalarial efficacy and drug interactions of the novel semi-synthetic endoperoxide artemisone in vitro and in vivo by Vivas L, Rattray L, Stewart LB, Robinson BL, Fugmann B, Haynes RK, Peters W, Croft SL. J Antimicrob Chemother. 2007 Apr; 59(4): 658-65. Epub 2007 Mar 2.
The in vitro and in vivo efficacy and drug–drug interactions of the novel semi-synthetic endoperoxide artemisone with standard antimalarials were investigated in order to provide the basis for the selection of the best partner drug. Artemisone represents an important addition to the repertoire of artemisinin combination therapies currently in use, as it has enhanced antimalarial activity, improved bioavailability and stability over current endoperoxides.
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L’ASAQ, une avancée dans la lutte contre le paludisme by Kiechel JR, Pecoul B. Med Trop 2007; 67: 109-110.
This editorial (in French) presents ASAQ, a fixed-dose combination of artesunate and amodiaquine launched in March 2007 by Drugs for Neglected Diseases initiative (DNDi) and sanofi-aventis. The combination is aimed for treating uncomplicated falciparum malaria in malaria-endemic countries in Africa.
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Nature Outlook Neglected Diseases Supplement by various authors. Outlook: Neglected diseases 2007 Sep (449) , No. 7159 pp157-182
Tropical diseases affect more than one billion people, yet there are few effective treatments. And despite much research activity, scientific innovations with therapeutic potential are not making it out of the laboratory. The articles in this Outlook examine what can be done to stimulate the development of effective medicines and deliver them to the people who need them most.
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Neglected diseases: progress in drug development by Croft SL. Curr Opin Investig Drugs. 2007 Feb;8(2):103-4.
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