MedPath

Golotimod

Generic Name
Golotimod
Drug Type
Small Molecule
Chemical Formula
C16H19N3O5
CAS Number
229305-39-9
Unique Ingredient Identifier
637C487Y09
Background

SCV-07 (g -D-glutamyl-L-tryptophan) is a novel synthetic dipeptide that acts broadly on the Toll-like receptor pathway. It has been shown to stimulate T-lymphocyte differentiation, macrocytic phagocytosis, and specific immune responses, and enhance IL-2 and INF-g production. Due to this preferential activation of Th1 cytokine production, SCV-07 may show utility in treatment of tuberculosis. It can be administered orally or subcutaneously. In independent studies, treatment of tuberculosis with SCV-07 improved clearance of mycobacteria, improved cavity healing, improvements in immune parameters and reduced symptoms (fever, weakness, sweating, dry cough, productive cough, dyspnea, chest pain, tachycardia) without any adverse local or general effects. SCV-07 has shown efficacy in treating various viral and bacterial infections.

Indication

Investigated for use/treatment in hepatitis (viral, C), infectious and parasitic disease (unspecified), and tuberculosis.

Extension Study SCI-SCV-HCV-P2-001: Long-Term FU in Subj Who Opt for Retreatment With Peg-INF and RBV After Completing Treatment in HCV

Completed
Conditions
Chronic Hepatitis C
Interventions
First Posted Date
2011-03-08
Last Posted Date
2012-03-08
Lead Sponsor
SciClone Pharmaceuticals
Target Recruit Count
12
Registration Number
NCT01310205
Locations
๐Ÿ‡บ๐Ÿ‡ธ

Univ of Louisville Med/Dental Complex, Louisville, Kentucky, United States

๐Ÿ‡บ๐Ÿ‡ธ

Walter Reed Army Medical Center, Washington, Washington, United States

๐Ÿ‡บ๐Ÿ‡ธ

AGMG Clinical Research, Anaheim, California, United States

and more 1 locations

Study to Evaluate the Efficacy and Safety of Three Different Doses of SCV 07 in Attenuating Oral Mucositis in Subjects With Head and Neck Cancer

Phase 2
Conditions
Oral Mucositis
Interventions
Drug: Placebo
First Posted Date
2010-11-24
Last Posted Date
2014-05-26
Lead Sponsor
SciClone Pharmaceuticals
Target Recruit Count
160
Registration Number
NCT01247246
Locations
๐Ÿ‡บ๐Ÿ‡ธ

The University of Illinois at Chicago, Chicago, Illinois, United States

๐Ÿ‡บ๐Ÿ‡ธ

Disney Family Cancer Center, Burbank, California, United States

๐Ÿ‡บ๐Ÿ‡ธ

Arizona Oncology Services Foundation, Phoenix, Arizona, United States

and more 46 locations

Proof-of-concept Study to Evaluate the Safety and Immunomodulatory Effects of SCV 07 as Monotherapy or in Combination With Ribavirin in Noncirrhotic Subjects With Chronic Hepatitis C Who Have Relapsed

Phase 2
Completed
Conditions
Chronic Hepatitis C
Interventions
First Posted Date
2009-08-31
Last Posted Date
2012-06-08
Lead Sponsor
SciClone Pharmaceuticals
Target Recruit Count
40
Registration Number
NCT00968357
Locations
๐Ÿ‡บ๐Ÿ‡ธ

Arapahoe Gastroenterology, Littleton, Colorado, United States

๐Ÿ‡บ๐Ÿ‡ธ

A Professional Corporation, Palm Springs, California, United States

๐Ÿ‡บ๐Ÿ‡ธ

University of Louisville, Louisville, Kentucky, United States

and more 13 locations

Dose Ranging Study to Assess the Safety and Efficacy of SCV-07 for the Delay to Onset of Severe Oral Mucositis in Patients Receiving Chemoradiation Therapy for Head and Neck Cancer

Phase 2
Completed
Conditions
Oral Mucositis
Head and Neck Cancer
Interventions
Drug: Placebo
First Posted Date
2008-09-22
Last Posted Date
2009-11-23
Lead Sponsor
SciClone Pharmaceuticals
Target Recruit Count
59
Registration Number
NCT00756951
Locations
๐Ÿ‡บ๐Ÿ‡ธ

Washington University in St Louis, St Louis, Missouri, United States

๐Ÿ‡บ๐Ÿ‡ธ

Karmanos Cancer Institute, Detroit, Michigan, United States

๐Ÿ‡บ๐Ÿ‡ธ

James Graham Brown Cancer Center, Lousiville, Kentucky, United States

and more 16 locations
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