Delving into the Latest Updates on Leish-111f with Synapse

Overview

Basic Info

Drug Type

Therapeutic vaccine

Synonyms

polyprotein vaccine consisting of the T-Cell antigens thiol-specific antioxidant, Leishmania major stress-inducible protein 1, and Leishmania elongation initiation factor, tandemly linked, multi-subunit recombinant leishmanial vaccine

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesSkin and Musculoskeletal DiseasesOther Diseases

Active Indication-

Inactive Indication

LeishmaniasisLeishmaniasis, CutaneousLeishmaniasis, Mucocutaneous+ [2]

Originator Organization

Infectious Disease Research Institute

Active Organization-

Inactive Organization

Infectious Disease Research Institute

Access To Advanced Health Institute

Corixa Corp.

License Organization-

Drug Highest PhasePendingPhase 2

First Approval Date-

Regulation-

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Infection with Leishmania parasites results in a range of clinical manifestations and outcomes. Control of Leishmania parasite transmission is extremely difficult due to the large number of vectors and potential reservoirs, and none of the current treatments are ideal. Vaccination could be an effective strategy to provide sustained control. In this review, the current global situation with regard to leishmaniasis, the immunology of Leishmania infection and various efforts to identify second generation vaccine candidates are briefly discussed. The variety of clinical trials conducted using the only current second generation vaccine approved for clinical use, LEISH-F1+MPL-SE, are described. Given that epidemiological evidence suggests that reducing the canine reservoir also positively impacts human incidence, efforts at providing a vaccine for leishmaniasis in dogs are highlighted. Finally, potential refinements and surrogate markers that could expedite the introduction of a vaccine that can limit the severity and incidence of leishmaniasis are discussed.

01 Apr 2010·VaccineQ3 · MEDICINE

Treatment of canine visceral leishmaniasis by the vaccine Leish-111f+MPL-SE

Q3 · MEDICINE

Article

Author: Melissa Abbehusen ; Steven G. Reed ; Yasuyuki Goto ; Jeffrey Guderian ; Geraldo Pedral-Sampaio ; Randall F. Howard ; Eduardo M. Netto ; Robson Silva de Jesus ; Joelma Trigo ; Maria Nakatani

Immunotherapy of canine visceral leishmaniasis (CVL) may provide an alternative to both marginally effective chemotherapy and undesired euthanasia of infected dogs and could have a great impact not only on animal welfare, but also on control of human disease. Therefore, we examined the potential immunotherapeutic efficacy of the subunit vaccine Leish-111f+MPL-SE, which has undergone rigorous preclinical testing and been demonstrated safe in human clinical trials. Two separate trials were performed in Salvador, Brazil, to evaluate the vaccine for therapeutic efficacy against CVL caused by natural infection: an Open Trial and a Blinded Trial. In the Open Trial 59 dogs with clinically active CVL were sequentially allocated to four groups: group 1 received Leish-111f+MPL-SE; group 2 was treated with Glucantime; group 3 received a combination of the vaccine and Glucantime; and group 4 was given no treatment. At the 6-month assessment, the 13 non-treated dogs had either died or showed no clinical improvement. In contrast, most dogs in groups 1-3 showed initial improvement (100%, 80%, and 92%, respectively). Upon evaluation for a mean of 36 months after therapy, the following cure rates were observed: 75% for group 1 dogs (exact 95% confidence interval [CI] 43-95%), 64% for group 2 dogs (exact 95% CI 31-89%), and 50% for group 3 dogs (exact 95% CI 19-81%). Therapeutic efficacy of the Leish-111f+MPL-SE vaccine was reconfirmed in a subsequent Blinded Trial. The vaccine was effective for mild cases of CVL and was compromised in dogs with severe disease. Although further studies are required to understand mechanisms of action, the Leish-111f+MPL-SE vaccine is a promising tool to control VL in both dogs and humans.

01 Mar 2010·VaccineQ3 · MEDICINE

Intranasal immunization with Leish-111f induces IFN-γ production and protects mice from Leishmania major infection

Q3 · MEDICINE

Article

Author: Takashima, Yasuhiro ; Matsumoto, Yasunobu ; Matsumoto, Yoshitsugu ; Reed, Steven G ; Hayashi, Yoshihiro ; Sakai, Shun-Ichi

The mucosal vaccination is a non-invasive alternative approach for not only mucosal pathogens but also parenteral pathogens, since it induces both mucosal and systemic immunoreactions. The purpose of this study was to evaluate the application of intranasal (i.n.) immunization with a recombinant leishmanial protein against Leishmania infection. BALB/c mice were i.n. administered 1-3 times with Leish-111f plus cholera toxin (CT) adjuvant (Leish-111f/CT). Splenocytes from i.n. immunized mice produced high level of IFN-gamma but not IL-4 in response to Leish-111f. When infected with 1x10(6) of Leishmania major promastigotes 2 weeks after the final administration, lesion development was completely controlled in all mice i.n. administered with Leish-111f/CT. Mice i.n. administered with Leish-111f alone showed neither cytokine productions nor lesion control even after 6 administrations, suggesting the importance of CT adjuvant. This report demonstrated for the first time that i.n. administration of a recombinant leishmanial protein induces Th1 type immunity and protects mice from Leishmania infection.

100 Deals associated with Leish-111f

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Leishmaniasis, Visceral	Phase 2	India	Access To Advanced Health Institute	01 Apr 2007
Post-Kala-azar dermal leishmanioid	Phase 2	India	Access To Advanced Health Institute	01 Apr 2007
Leishmaniasis, Cutaneous	Phase 2	Colombia	Access To Advanced Health Institute	01 Aug 2005
Leishmaniasis, Mucocutaneous	Phase 2	Peru	Access To Advanced Health Institute	01 Jul 2004
Leishmaniasis	Phase 2	United States	Infectious Disease Research Institute	01 Aug 2002