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Abstracts 751-1000 211 this analysis. Blood PYR concentrations were natural log-transformed. 710 Two- and three-compartment models were fitted to the data using NONMEM. The influence of covariates (age, sex, weight, height, body ACTIVITY OF 8-AMINOQUINOLINE (8AQ) ANTIMALARIAL mass index, lean body weight (LBW), red blood cell indices, parasite DRUG CANDIDATES AGAINST BLOOD STAGE PLASMODIUM count, liver function tests and geographic regions) on PK parameters FALCIPARUM was tested. Bootstrap analysis and visual predictive check (VPC) were 1 1 1 done to evaluate the model. A two-compartment model with first order Yarrow Rothstein , Jacob Johnson , Aruna Sampath , William 1 2 2 2 absorption and elimination best described the data. Inter-subject variability Ellis , Dhammika Nanayakkara , Ikhlas Khan , Larry Walker , Alan 1 1 (ISV) of absorption rate constant (Ka), oral clearance (CL/F), and apparent Magill , Colin K. Ohrt central compartment volume (V2/F) were described using an exponential 1Walter Reed Army Institute of Research, Silver Spring, MD, United States, error model. The ISV of peripheral compartment volume (V3/F) and 2National Center for Natural Products Research, School of Pharmacy, intercompartmental clearance (Q/F) could not be estimated. A log error University of Mississippi, University, MS, United States model best described residual variability. Only LBW was found to be a 8-aminoquinolines (8AQ) may prove critical for malaria elimination significant predictor of V2/F. Typical model parameter estimates (%ISV) efforts since they target hypnozoites and Plasmodium falciparum (Pf) were Ka 29.3 1/d (109%), CL/F 1180 L/d (50%), V2/F 8540 L (82%), gametocytes. It is unclear if 8AQs could have a role in targeting the V3/F 13200 L and Q 1720 L/d. The estimated elimination half-life was remaining component of the transmission reservoir - asymptomatic blood 18 days. The final model provided estimates within the 95% confidence stage parasitemia. The key toxicity in this class will soon be addressed with intervals obtained by 1000 bootstrap runs. VPC showed that the final animal models predicting hemolytic toxicity in G6PD-deficiency. The Walter model adequately captured the majority of the data. In conclusion, a Reed Army Institute of Research chemical information system contains 2-compartment model was well-fitted to pyronaridine data. LBW was an data on 1803 8AQs. Of these, 106 have been tested in vitro against Pf, important covariate of V2/F in adult patients. The parameter estimates with 33 having IC50’s < 200 ng/ml. Of 1457 compounds assessed in were plausible. The final model was robust and sufficiently captured the a single dose mouse P. bergheii blood stage model, 195 had curative overall PYR PK. activity. Ten out of ten assessed as single agents in a 3-day Aotus monkey P. falciparum treatment protocol had curative activity. We plan to evaluate 709 the in vitro efficacy of all available 8AQs against P. falciparum in vitro, to PUNICALIN AND PUNICALAGIN FAILS CEREBRAL MALARIA? confirm their lack of cross-resistance with standard antimalarial drugs, and to determine if efficacy can be separated from hemolytic toxicity. The Deepak X. Bhattacharya existing data and new data relevant to P. falciparum blood stage efficacy Oddisi Research Laboratory, Bhubaneswar, Orissa, India and therapeutic index will be presented. In AJTMH 2003, 2004 & Multi Lateral Initiative on Malaria Yaounde-05, 711 introduced Indo medicinal fruit called Dalimba (P granatum) having therapeutic & prophylactic efficacy against drug resistant malaria Pf -Pv, PHARMACOKINETICS (PK) AND QTC CHANGES AFTER alongwith active moieties, efficacy spectrum, scavenger/anti-oxidative/anti- COADMINISTRATION OF TAFENOQUINE (TQ) AND inflammatory, anti-viral, adjuvant, & K+ as driver candidate (as reported CHLOROQUINE (CQ) IN HEALTHY VOLUNTEERS previously). Is a CAM, a invention on global basis termed OMARIA-Orissa Malaria Research Indigenous Attempt (BBC & Eco.Times, India, 24/25- Ann K. Miller1, Khadeeja Mohamed2, Li Ye3, Emma Harrell4, 10-2000). In vitro results presented from authentic source (as reported Sharon Baptiste-Brown1, Jörg-Peter Kleim2, Colin Ohrt5, Stephan previously). Decadal mono-station continuous large scale use (Koraput- Duparc6, Andrew Beelen7, Alison Webster2, Sandy Griffith8 Orissa-India) indicates that >15000 individuals & whole families who all 1GlaxoSmithKline Pharmaceuticals, King of Prussia, PA, United States, had consumed OMARIA seem to block transmission for years end, no 2GlaxoSmithKline Pharmaceuticals, Uxbridge, Middlesex, United Kingdom, signs of resistance, non ever developed cerebral malaria. Why? OMARIA 3 GlaxoSmithKline Pharmaceuticals, Collegeville, PA, United States, contains 1 small, stable, (A-i) Ellagic acid rich in H+, clinically indicates 4GlaxoSmithKline Pharmaceuticals, Harlow, Essex, United Kingdom, hepatogen, pylori & nephron toxic symptoms at sustained/bolus doses, & 5Walter Reed Army Institute of Research, Silver Spring, MD, United 2 unstable, large, hydrolytic Ellagitanins (B-ii) Punicalagin & (B-iii) Punicalin/ States, 6Medicines for Malaria Venture, Geneva, Switzerland, 7Miriad folin of low H+, rich in OH, wholly non toxic (C-i) K+. Which Group Pharmaceuticals, Salt Lake City, UT, United States, 8GlaxoSmithKline inflicts thus ? Or A + B + C = synergistic action ? In Indian natural sources, Pharmaceuticals, Research Triangle Park, NC, United States group B is > group-A, non confounding. K+ binds exclusively to group B, which has longer bio-availability (Sreeram-04; Soh-08). Homeopaths Tafenoquine (TQ) is an 8-aminoquinoline in development for the treatment use diluted Acetic acid; Ellagic Acid (0.25~5%) as internal medicine to and radical cure of Plasmodium vivax malaria. TQ will be coadministered treat tertian malaria Pf-Pv. Initially all case report relief, then rebound with (not coformulated) with chloroquine (CQ). The PK and safety of TQ, hepatic, digestive, bowl problems, long use complication = drug failure. CQ and its desethyl metabolite (DECQ) were evaluated when given Very same cases report feel good factor & eventual ‘clinical clear status’ concomitantly compared to TQ or CQ given alone in healthy adults. Due with OMARIA. Tertian cases treated with fruits & herbs rich in group A to the long half-lives of both TQ and CQ, a double-blind, parallel group (Chestnut bark) & non from group B is ineffective & also non gametocidal. design with 20 subjects/group was used: CQ alone (600mg on D1 and Group A do not deliver prophylaxis nor as safe. Drug dose therapeutic D2+300mg on D3); TQ alone (450mg on D2 and D3); and CQ plus TQ at response of Group-A is even not equal to Artimisinin. Group B-ii & B-iii → the same doses and times. Frequent blood samples for PK were taken on slow onset, long acting, potent, therapeutic, prophylactic, pregnancy safe D2 and D3 with additional samples taken out to D56. 12-Lead ECGs were & Gametocidal even at sub-clinical doses. K+ (C-i) thwarts neuro-cerebral collected in triplicate on D-1; pre-dose, 2 and 12 h post dose on D1-3; and morbidity. daily on D4-7. Plasma TQ, CQ and DECQ concentrations were determined using an HPLC-MS/MS method. PK parameters were determined using non-compartmental methods. Only a short term significant effect on TQ PK was seen on D2 when taken with CQ (Cmax and AUC(0-24) increased 38% and 24%, respectively) with no significant effects seen for Cmax and AUC(0-24) on D3, AUC(0-∞) and t1/2. TQ had no significant effect on CQ and DECQ PK. No subjects had a QTcF >480msec or a change from baseline ≥ 60msec. QTcF intervals increased when treated with CQ alone but there was no trend for increased QTcF intervals in those treated www.astmh.org 212 with TQ alone nor a trend for increased QTcF intervals in the CQ/TQ arm significant difference in Hemotoxicity in vitro. 5-HPQ and MAQ produced beyond those seen with CQ alone. On D2 and D3, maximum increases robust increase in methemoglobin and oxidative stress both in normal and in mean change from baseline QTcF interval seen in the CQ/TQ arm were G6PD(-) erythrocytes. However, the metabolites generated concomitant 5msec compared to CQ and 33msec compared to TQ. Corresponding depletion of GSH only in G6PD(-) erythrocytes, which may be responsible increases from baseline QTcF intervals were seen with increases in CQ for selective susceptibility of G6PD(-) individuals to hemolytic response and DECQ plasma concentrations. No correlation was seen between TQ during treatment with PQ. Depletion of GSH may be monitored as a concentrations and change from baseline QTcF intervals. Mild elevations marker for susceptibility of individuals to PQ toxicity. in methemoglobin occurred, maximum mean change from baseline was on D14 (6% in CQ/TQ, 4% in TQ, and <1% in CQ). Safety and tolerability 714 for CQ/TQ were generally similar to TQ alone. Overall, no significant PK or QTcF interaction between TQ and CQ was seen in this study. NOVEL AMINOINDOLE INHIBITORS OF PLASMODIUM FALCIPARUM: IN VIVO EFFICACY AND PRELIMINARY SAFETY 712 ASSESSMENT DEVELOPMENT OF A NOVEL CHEMICAL SERIES WITH Robert H. Barker1, Sameer Urgaonkar2, Mikaela Levine1, 1 1 2 ACTIVITY AGAINST BOTH BLOOD- AND LIVER-STAGES OF Cassandra Celatka , Renato Skerlj , Joseph F. Cortese , Hanlan 1 3 3 PLASMODIUM FALCIPARUM Liu , Jose E. Guerrero-Bravo , Keila N. Krespo-Llado , Adelfa E. Serrano3, Jin-wen Lin4, Chris J. Janse4, Shaheed M. Khan4, Manoj Clare E. Gutteridge1, Michael C. Baxter1, Stephen M. Hughes1, Duraisingh5, Bradley Coleman5, Inigo Angulo-Barturen6, Maria B. Brett W. Sadowski1, Leighton
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