A Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study to Assess the Clinical Efficacy, Safety, and Immunogenicity of a Human Cocaine Vaccine (TA-CD) in the Treatment of Cocaine Dependence

The purpose of this study is to test the efficacy of a newly developed active vaccine against cocaine (TA-CD).

开始日期2010-08-01

申办/合作机构

Baylor College of Medicine

[+8]

NCT01369121 / Terminated临床1/2期

A Phase I/II Open Label Individual Dose Titration Trial of the Human Corticotropin- Releasing Factor (hCRF), Corticorelin Acetate Injection (Xerecept®), to Determine the Tolerability of Xerecept® in a Pediatric Population

This study is being conducted to evaluate the safety and tolerability of Xerecept® in children with central nervous system tumors and to identify appropriate doses of Xerecept® to be used in subsequent pediatric clinical trials.

开始日期2010-06-01

申办/合作机构

Celtic Pharma Development Services, Inc.

NCT01145807 / Unknown status临床3期

A Randomized, Double-blind, Vehicle- and Placebo-Controlled, Multicenter Trial in Patients With Mild to Moderate Distal Subungual Toenail Onychomycosis to Investigate the Efficacy, Tolerability, and Safety of Twice Daily Application of TDT 067 for 48 Weeks

The aim of this study is to establish the efficacy, clinical benefits, and safety of treatment with TDT 067 for clinically diagnosed distal subungual onychomycosis of the toenails caused by dermatophytes confirmed by positive mycology.

开始日期2010-04-01

申办/合作机构

Celtic Pharma Development Services, Inc.

[+1]

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项与 Celtic Pharma Development Services, Inc. 相关的文献（医药）

2010-04-15·Cancer Research

Abstract 1557: Corticorelin acetate exhibits preclinical antitumor activity, alone and with bevacizumab, against human brain tumor models

作者: Gamez, Maria I. ; Ryan, Robert P. ; Keir, Stephen T.

AbstractCorticorelin acetate is a synthetic form of corticotropin-releasing factor undergoing clinical trials in the treatment of peritumoral brain edema. We investigated preclinically its potential as an antitumor agent against orthotopically implanted human brain tumors, and its ability to enhance the therapeutic activity of bevacizumab in one of these models.Intracranial (ic) tumor transplantation into the right cerebrum was performed using two patient-derived human tumor xenografts: D-341MED pediatric medulloblastoma and D-456MG pediatric multiforme glioblastoma. Mice were randomized 3 days after ic tumor implantation at which time all treatments were begun. Corticorelin acetate was administered at 0.1 and/or 0.2 mg mg/kg/dose, sc, twice daily (bid) depending upon the experiment. Bevacizumab was administered at a dose of 5 mg/kg/day, intraperitoneally (ip), twice weekly. Treatments were continued until a median day of death was reached for each group. In both studies antitumor effects were evaluated based on a survival analysis (Kaplan-Meier).In the D-341MED, comparing treatments vs control, the low dose corticorelin acetate produced a 56% increase in life span (ILS) (p<0.001); the higher dose of corticorelin acetate yielded a 20% ILS which was also statistically different than the control group (p<0.05). In the D-456MG ic-implanted tumor experiment, corticorelin acetate (0.2 mg/kg/dose, bid, sc) achieved a 42% ILS (p<0.001) while bevacizumab produced a 64% ILS (p<0.001). When the two drugs on these same regimens were applied in combination, the resulting ILS of 92% (p<0.001 versus control) represented a therapeutic enhancement that was statistically different (p<0.05) from either solo drug treatment.Conclusion: Corticorelin acetate significantly increased the lifespan of mice implanted orthotopically with two different pediatric brain tumor models. In the D-456MG model, in which corticorelin acetate and bevacizumab were evaluated, the combination produced a therapeutic outcome superior to that found using either of the two agents alone.Citation Format: {Authors}. {Abstract title} [abstract]. In: Proceedings of the 101st Annual Meeting of the American Association for Cancer Research; 2010 Apr 17-21; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2010;70(8 Suppl):Abstract nr 1557.

2010-04-15·Cancer Research

Abstract 1554: Corticorelin acetate, a synthetic corticotropin releasing factor, demonstrates antiangiogenic and antitumor activity alone and enhances bevacizumab activity in human tumor models

作者: Gamez, Maria I. ; Hollister, Beth A. ; Reid, LaKesha D. ; Routt, Sheri M. ; Ryan, Robert P.

AbstractCorticorelin acetate (CrA) is a synthetic form of corticotropin-releasing factor undergoing clinical trials in the treatment of peritumoral brain edema (PBE). A corneal micropocket angiogenesis assay (CMA) was performed to assess the activity of CrA relative to bevacizumab (BEV). We also investigated the in vivo anti-tumor efficacy of CrA as a single agent and in combination with BEV, in two preclinical human tumor models, the MX-1 breast and Colo-205 colon carcinomas. These models were selected based on their sensitivity to BEV.In the CMA, six groups of female mice were implanted with pellets containing VEGF or no VEGF, and treated for 7 days. The vehicle control group received phosphate buffered saline, sc, bid. The positive reference group received BEV, ip, qd, at 5 mg/kg/inj. The two remaining groups received CrA sc, bid, at 0.1 mg/kg/inj or 0.2 mg/kg/inj. Treatment outcome was determined from semi-quantitative characterization of neovascularization. CrA produced a substantial (>70%) inhibition of neovascularization (p<0.01) in the CMA.In the xenograft studies, mice were implanted sc in the flank with approximately 1 mm3 tumor fragments obtained from donor passage mice (MX-1), or with 1 × 106 tissue culture-derived Colo-205 cells implanted in 50% matrigel. When tumors were generally between 80-240 mg (mm3), mice were distributed to control and treatment sets. CrA was administered at two dose levels, 0.1 and 0.2 mg/kg/injection, sc, twice daily (bid). BEV was administered at a dose of 5 mg/kg/inj, ip, twice weekly. All treatments were continued until each group achieved its tumor target size, 1 gm in the Colo-205 experiment, and 1.5 gm in the MX-1 experiment. A log cell kill (LCK) of ≥1.0, equivalent to a delay in tumor growth of ≥ 3.32 x tumor volume doubling time, accompanied by statistical significance (p<0.05) was considered indicative of activity.CrA was active as a single agent in the MX-1 breast carcinoma (1.0 LCK; p<0.02), but inactive in the Colo-205 colon carcinoma. BEV was active (1.1 LCK; p<0.002) or near active (0.9 LCK; p<0.001) in both the MX-1 and Colo-205 models, respectively. When BEV was administered concomitantly with CrA, therapeutic outcomes were observed that were significantly better (3.3 LCK in MX-1, p<0.03; 1.9 LCK in Colo-205, p<0.01) than those obtained using either monotherapy. These therapeutic potentiations using CrA plus BEV were obtained in the absence of any observable increase in toxicities.Conclusion: CrA has demonstrated anti-angiogenic activity in vivo, which may be one possible mechanism to explain its observed preclinical antitumor activity. Importantly it enhances the antitumour activity of BEV in both MX-1 and Colo-205 models. Given the good safety profile of CrA and its lack of hypertensive side effects in clinical trials, CrA should be evaluated clinically in combination with BEV.Citation Format: {Authors}. {Abstract title} [abstract]. In: Proceedings of the 101st Annual Meeting of the American Association for Cancer Research; 2010 Apr 17-21; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2010;70(8 Suppl):Abstract nr 1554.

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